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Coalition of Silicone Survivors

Coalition of Silicone Survivors

http://www.siliconesurvivors.net/newsletters/jun.02.news.html

~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~

 

June 2002 news (Lynda Roth, Sat Feb 22 10:00:54 2003)

COALITION OF SILICONE SURVIVORS
2739 W. 23rd St., Greeley, CO 80634
Lynda Roth - (970) 506-9288 Fax (970) 506-9288 (call first)
e-mail: : coss1@qwest.net
Website: http://www2.privatei.com/~coss/coss

June 1, 2002

Dear Silicone Survivors and Friends:

Since the court had held the appeals hearing (June 14, '02) and a ruling
will probably not be issued for at least 30 days, we are putting this
newsletter out with the latest information that we have. It would be nice
to be able to report that we will receive some funds soon, but I do not
expect any payouts until at least next June (2003).

We continue to lose wonderful women. One that I knew since the early
'90's, Alice Cooke of Ohio, died recently. I hear about at least one woman
a month that has lost her life due to silicone poisoning. It does not get
easier.

LEGAL INFORMATION: Please feel free to contact one of the Telehelp
information numbers or websites listed for further information. Dow Corning
Bankruptcy Telehelp and Other Information Sources List: Dow Corning
Bankruptcy Case General Information Line: 800-651-7030 (recorded message);
US Bankruptcy Court Information Line: 800-222-7198; Dow Corning Info. Line:
(800) 997-1700.

TCC Mailing Address: Tort Claimants Committee, P.O. Box 61406, Houston,
Texas 77208-1406. TCC website: www.tortcomm.org Phone: (713)
547-2271. For the actual Dow Corning website: www.implantclaims.com
The settlement facility website is: www.dcsettlement.com

If you have a change of name or address, send it to: Settlement Facility
DCT, P.O. Box 52429, Houston TX 77052. Their phone #: (866) 874-6099 for
the US and Canada, other countries dial (713) 874-6099. You must submit
address or name changes in writing. You must also submit any name change or
address change to: Bankruptcy Claims Administration Facility, P.O. Box
7500, Midland, MI 48641-7500.

For inquiries not involving Dow Corning but the different legal case
generally referred to as the MDL Class Action and Revised Settlement
Program, you should contact different numbers: MDL Claims
Center: 800-600-0311 (outside the U.S.
call 713-951-9106) MDL Claims Center
Mailing Address: P.O. Box 56666, Houston, Texas 77256.

If you have not filed a claim for implants other than Dow Corning,
Cox-Uphoff, Mentor, McGhan, or Bioplasty (ie. Bristol-Myers, etc.) and you
are now ill, late registration for the MDL-926 Revised Settlement Program
(Long-term diseases only) you have until Dec. 15, 2010 to file. If you
filed under the long-term disease category and were paid for less than 100%
disability and you are now 100% disabled, you may refile in a higher
category. If you filed in a fixed amount category in levels ABC, you may
not refile even if you are worse. I know this sounds confusing. The MDL
Claims Center #, above, will be useful in making this clearer.

UPDATED JUNE 18, 2002: This is an update on the hearing before United
States District Judge Denise Page Hood on Friday, June 14, 2002 in Detroit.
The hearing concerned objections and appeals filed by certain Nevada and
Australian claimants and several pro se claimants (claimants who are
representing themselves without an attorney). These objectors argued that
the Dow Corning Settlement Plan could not legally release Dow Chemical,
Corning and subsidiary companies of Dow Corning from liability for Dow
Corning's breast implants. The objectors want the ability to collect money
from Dow Corning in the Settlement Plan AND also be able to sue Dow
Chemical and/or other related companies outside of the bankruptcy court
proceedings. In January 2002, the 6th Circuit Court of Appeals addressed
their objections and ruled that the release of liability of the non-debtor
companies under a bankruptcy reorganization plan was permissible. In other
words, the 6th Circuit court ruled that Dow Chemical and the other related
companies could be released from liability for Dow Corning's breast
implants as part of a reorganization of Dow Corning in bankruptcy. The 6th
Circuit Court Āsent the case back to Judge Hood for further proceedings to
determine if the trial record contained facts that support the release of
liability in this case. Specifically, the 6th Circuit Court ordered the
District Court Judge to determine if there were facts in evidence regarding:

"whether there is evidence that Dow Corning and Dow Chemical for example
have an identity of interests such that a lawsuit against Dow Chemical is,
in essence, a lawsuit against Dow Corning or will deplete the assets of Dow
Corning;

" whether Dow Chemical and the other non-debtor companies contributed
substantial assets to the Settlement Plan in exchange for the release;

"whether the release of liability of Dow Chemical is essential to Dow
Corning's ability to emerge from bankruptcy free of liability from claims
by Dow Chemical;

"whether the Settlement Plan provides a way to make sure that the claimants
affected by the release will be paid; and

"whether the Settlement Plan provides an opportunity for claimants to
litigate in court and be paid in full.

Written briefs and objections on the "release" issue were submitted to
Judge Hood earlier this year. The Tort Claimants Committee believes that
the trial record has sufficient facts in evidence to justify the release of
Dow Chemical and the other related companies in this case. The hearing on
June 14th was to allow all parties to make any additional oral arguments
regarding the release of liability issue. The release of Dow Chemical,
Corning and the subsidiary companies is the ONLY issue left to resolve in
the pending appeals.

Judge Hood heard the oral arguments and indicated that she would like to
move quickly in issuing a ruling. We do NOT know when she will issue her
ruling. We will post any news or developments on this issue on the website.

SETTLEMENT WITH U.S. GOVERNMENT ANNOUNCED AT THE HEARING

During the June 14th hearing, the Tort Claimants Committee and Dow Corning
announced that they had successfully negotiated a settlement with the
United States Government. The U.S. Government informed the Court that it
was in the process of obtaining final approval from the various federal
agencies and hoped to have the necessary signatures within approximately
30-45 days. To recap, the U.S. Government filed claims in the bankruptcy
alleging that it paid money to doctors and hospitals on behalf of women who
had Dow Corning implant related treatment (such as removal of a Dow Corning
breast or other type of implant or medical treatment for illnesses caused
by ĀDow Corning implants). The U.S. Government sought to recover these
types of medical expenses directly from Dow Corning under various Medicare
recovery provisions. The U.S. Government has objected to the Settlement
Plan since it was announced in 1998, and has filed appeals to the 6th
Circuit Court of Appeals.

Theproposed settlement will settle and release from liability Dow Corning
and all "Personal Injury Claimants" (i.e., persons who filed an
implant-related claim) for any payments they receive from Dow Corning, the
Settlement Facility or Litigation Facility. For claimants who filed an
implant claim in the bankruptcy case and received Medicare or other type of
medical assistance for your Dow Corning implants, this means that if you
receive any money from the Dow Corning settlement plan regardless of
whether you settle your claim or litigate your case in court you will NOT
have to pay or repay any money to the U.S. Government for claims arising
pursuant to Medicare Secondary Payer Statute or the Medical Care Recovery
Act.

EXAMPLE: If you received Medicare or Medicaid coverage (or medical
coverage from the Department of Veteran Affairs, Department of Defense or
Indian Health Services) for medical treatment related to your implant, AND
you receive a payment from the Dow Corning Settlement Plan, then you will
NOT be required to repay the U.S. Government back for those medical
expenses.The proposed settlement releases claimants and Dow Corning from
this obligation. If you do not receive any payments from the Dow Corning
Settlement Plan, then the U.S. Government may still pursue you for
reimbursement of any compensation you received from other implant companies
for your Medicare medical expenses (i.e., you do not qualify to receive any
money from the Dow Corning Settlement Plan but you received money from the
MDL or from a settlement with one of the implant companies, then you are
still responsible to reimburse the U.S. Government for any Medicare
implant- related expenses).

If you received Medicare or Medicaid coverage for a breast implant, you
have a breast implant made by Dow Corning AND another breast implant made
by someone else AND you receive any money from the settlement plan
regardless of whether you settle your claim or litigate your case in court
you will not have to pay or repay any money to the U.S. Government EXCEPT
THAT the U.S. Government may assert a claim for any costs it incurred for
paying for the removal of the non-Dow Corning breast implant.

EXAMPLE: If you received Medicare or Medicaid coverage (or medical
coverage from the Department of Veterans Affairs, Department of Defense or
Indian Health Services) for medical treatment related to your implant, AND
have a Dow Corning breast implant and an implant made by Bristol, AND you
receive money from the Dow Corning settlement plan, then you will NOT be
required to repay any of that money to the U.S. Government except for costs
the U.S. Government incurred for removal of your non-Dow Corning breast
implant.

A hearing on the proposed settlement with the U.S. Government will be held
on July 18th in Detroit. We will post all updates and developments on this
website. www.tortcomm.org

Sincerely,
Dianna Pendleton, Counsel to the TCC

I contacted Patrick Hughes to ask about this recent hearing, and this was
his comment: "As I understand it, Friday's hearing was unfortunately
uneventful in that there were no rulings issued. The sense was that Judge
Hood is prepared and wants to rule soon, but apparently wanted to allow
some pro se claimants to first have the chance to present some additional
arguments and briefing by month end before doing so. As a result, we may
not see any rulings for 30 days. The request is that she rule based on the
current evidence before her and to confirm that the plan and releases are
adequate and supported to allow the plan to be implemented. But the
opposition remains, and a request by the Nevada claimants has been made for
the Supreme Court to review the matters before there are further
proceedings below. That is where we are for now."

So, if you are wondering, the appeals are still in progress and we do not
expect all of them to be resolved until 2003 sometime.

Here's the latest from the Nevadans re Appeals, etc.: Unlike the U.S.
Government, the Nevadans did not seek a second hearing before the 6th
Circuit Court of Appeals and ask for them to reconsider. It should be
remembered that the 6th Circuit did not find that there were "unusual
circumstances" that would justify, on the record, what Dow Corning and the
Tort Claimants' Committee tried to do in this case, namely wipe out the
Nevadans' claims against the non-bankrupt Dow Chemical. However, the
Nevadans' victory in the 6th Circuit is not a complete victory unless and
until the U.S. Supreme Court resolves the conflict in the Circuit Courts of
Appeals in this country and rules that, regardless of "ununusual
circumstances," a non-bankrupt party like Dow Chemical is not entitled to
the benefits of bankrtupcy law (e.g., a free ticket out of litigation)
without undergoing the burden of filing bankruptcy itself.

So, rather than wait till the end of the upcoming hearings before Judge
Hood (held June 14th) where the TCC and Dow Corning get a "third bite" at
the apple in hopes of showing Judge Hood that "unusuual circumstances"
exist to allow Dow Chemical to ride Dow Corning's coattails out of
litigation - - the Nevadans sought to speed
up that process by filing a Petition for Certiorari (akin to an appeal) to
the U.S. Supreme Court asking them to rule, like Judge Spector ruled, that
a bankruptcy court does not have the legal power to extinguish the
liability that a non-bankrupt party (Dow Chemical) owes to non-consenting
creditors who refuse to go along with this charade (the Nevadans).

While Petitions for Certiorari are routinely denied by the U.S. Supreme
Court, the Nevadans hope their Petition will be the exception to the
rule. And, while we have every confidence that Judge Hood will conclude
that no "unusual circumstances" exist to wipe out the Nevadans' claims
against Dow Chemical, we have asked the U.S. Supreme Court to intervene at
an early stage in hopes of short-circuiting the necessity of such a
hearing, which would be followed by an inevitable round of appeals by
whoever the losing parties are following such a hearing. Further, it was
necessary for the Nevadans to file said Petition to preserve their
objection to that portion of the 6th Circuit ruling which said that in rare
and unusual circumstances a company like Dow Chemical might be able to get
a release from liability without filing for bankruptcy. (While I disagree
with the philosophy behind the Nevadans claims, as over 94% of women voted
for the bankruptcy settlement, I totally support their right to appeal
these decisions. This is what America is about! Lynda)

This is a response to a question about Mentor ruptures and the Dow
Bankruptcy. "Unfortunately there is no rupture benefit in the Dow Corning
plan for anyone other than those who have implants actually made by Dow
Corning. So only those seeking to litigate--itself a hard road as you can
imagine given the Dow's tenacity--would have an opportunity to try to
recover for a rupture and even then it would be extremely difficult given
the fact the Dow Corning did not make the actual implant and thus might
have no legal responsibility for a rupture, as opposed to possible
consequences arising from gel that Dow Corning may have supplied. And as
you may already know, in a litigation context rather than settlement, the
gel claims face huge hurdles even aside from causation, given the bulk
supplier defense that other makers have successfully used to obtain a
summary judgment. Regards.
Patrick L. Hughes
Haynes and Boone, L.L.P.
1000 Louisiana, Suite 4300
Houston, Texas 77002
713-547-2550 (direct)
713-236-5401 (direct fax)
713-547-2000 (main number)

MEDICAL INFORMATION:. San Francisco (Reuters Health) 11/16/01: Brain Scans
Show Increased Pain Sensitivity in Fibromyalgia: - Brain scans have
revealed that women with fibromyalgia differ from depressed women in their
sensitivity to pain, researchers reported here on Wednesday at the American
College of Rheumatology's annual meeting. Because nearly half of
fibromyalgia patients have had clinical depression at some point in their
lives, some doctors consider the condition to be a physical manifestation
of an underlying mood disorder, said Dr. Leanne R. Cianfrini, a psychology
researcher at the University of Alabama at Birmingham.

"Because fibromyalgia doesn't have a clear-cut etiology, it leads many
rheumatologists to interpret their pain as a simple physical manifestation
of an underlying depression," she said. "This can be frustrating and
counterproductive to patients." To see if there are physiological
differences between patients with fibromyalgia and patients with
depression, the investigators compared pain thresholds and brain activity
among 21 women with fibromyalgia, 8 women with depression and 22 healthy
women. Dr. Cianfrini and colleagues administered pressure calculated to be
a level above each woman's pain threshold to three points on the women's
bodies. The women were asked to evaluate their pain levels. The
researchers also used brain imaging to measure blood flow during reports of
pain.

The investigators found that the women with fibromyalgia had lower pain
thresholds and reported more pain after pressure stimulation than the
healthy women. The fibromyalgia patients also showed greater activation of
brain structures that process pain. The pain threshold and experience of
pain among the depressed women was similar to that of the healthy women,
the study found. "We can't deny depression is associated with
fibromyalgia, and it may exacerbate it," Dr. Cianfrini said. "But
depression does not seem to be a necessary factor." In a similar study,
Dr. Richard H. Gracely, a research psychologist at the National Institutes
of Health, presented findings on how the brains of fibromyalgia patients
react to pain.

Dr. Gracely and colleagues used functional MRI to compare fibromyalgia
patients with healthy patients experiencing pain. The research team found
that patients with fibromyalgia who were given relatively low levels of
pressure seemed to experience the same amount of pain and subsequent brain
activity as healthy people experiencing high levels of induced pain. "One
of the big issues of pain patients is credibility they don't have the
luxury of physical signs; nobody believes they have what they say," Dr.
Gracely said. However, these findings provide physical evidence to confirm
what fibromyalgia patients report, he added.

Some Quit Joint Replacement Settlement (AP) Cleveland: About 120 patients
who experienced faulty hip and knee replacements plan to opt out of a $1
billion settlement in a class action lawsuit. Nearly 3,500 patients
nationwide who received faulty artificial joints made by Austin,
Texas-based Sulzer Orthopedics are covered by the settlement. Parent
company Sulzer Medica, located in Switzerland, said Thursday that it will
negotiate to reduce the number of patients opting out of the settlement.
Sulzer's lead counsel, Richard Scruggs, has said that patients who choose
to pursue litigation independently could bankrupt the company.

Those who got the implants replaced without complications will each receive
about $200,000 under the settlement. The payment will be higher for
patients with complications. About $40,000 of each patient's share will go
toward attorney fees. Cleveland U.S. District Judge Kate O'Malley approved
the settlement last week following a two-day hearing. In December 2000,
the company was forced to recall thousands of artificial joints due to a
manufacturing problem that had contaminated some with an oily residue. The
substance prevented the new joint from bonding with patients' bones. The
agreement specifies that Sulzer Medica should pay $725 million toward the
settlement.

Residual Capsule and Intercapsular Debris As Long Term Risk Factors by Dr.
Pierre Blais: Contamination of the space between the capsule and the
implants by micro- organisms, silicone oils, degradation products and gel
impurities constitutes a major problem which potentiates the risk of
implants. Such problems include inflammation, infection, deposition of
mineral debris, as well as certain auto-immune phenomena. These problems
can be present when implants are in situ (in the body) and are often
attributable to the implant. The logical expectation is that, upon removal
of the implants, adverse effects will cease. This is an unjustifiably
optimistic view. It is well documented from case histories that removal and
or replacement of implants without exhaustive debridement of the prosthetic
site leads to failure and post surgical complications.

Plastic surgery procedures tend to favor speed and immediate cosmetic
results. For these reasons, leaving or "reusing" tissue from an existing
capsule may seem more "gratifying" However, adverse effects resulting from
the practice are widespread but have not been well documented. Typically,
patients who require removal of faulty implants and undergo immediate
re-implantation in the same prosthetic site habitually relapse with the
same problem which motivated the previous surgery; the most common example
is exchange of implants and/or sectorizing or bisecting the capsule without
removing it completely.

Such patients rarely achieve a significant capsular correction and
habitually return for more similar surgery. A more illustrative situation
is that where patients do not receive replacement implants. They form the
basis of knowledge for evaluating the risks that arise from remaining
capsules. An example is described in a paper published in 1993 (Copeland,
M., Kessel, A., Spiera, H., Hermann, G., Bleiweiss, I. J.; Systemic
Inflammatory Disorder Related To Fibrous Breast Capsules After Silicone
Implant Removal; Plastic and Reconstructive Surgery: 92 (6), 1179-1181,
1993): reported problems derived primarily from immune phenomena and
inflammatory syndromes with pain, swelling, serologic abnormaladies and
alarming radiologic presentation. Numerous similar cases have been noted
amongst implant patients but have not been theobject of publications. Some
are cited in FDA Reaction Reports. Others appear in theU.S. Pharmacopoeia
Reporting Programs.

A residual capsule is not a stable entity. It may collapse upon completion
of surgery and remain asymptomatic for some time, however, it will fill
with extracellular fluid and remain as a fluid-filled space with added
blood and prosthetic debris. As the wall matures and the breast remodels to
accommodate the loss of the prostheses, the capsular tissue shrinks. Water
as well as electrolytes are expelled gradually from the pocket or else the
mixture is concentrated from leakage of water from the semi-permeable
capsular membrane wall.

In most cases, calcium salts precipitate during that stage and may render
the capsule visible as a radiodense and speckled zone in radiographic
projections. Prosthetic debris is also radiodense and may be imaged to
further complicate the presentation. The average size of the residual
capsules after 6-12 months is in the 2-7 cm range: most are compact,
comparatively small and dense. Surgical removal should present no
difficulty for most patients if adequate radiographic information is available.

Later stages of maturation include the thickening of the capsule wall,
sometimes reaching 0.5-1cm. Compression of the debris into a cluster of
nodules which actually become calcified follows for some patients. A few
mimic malignancies. Others appear as small "prostheses" during mammographic
studies. They are alarming to onocologists and are habitually signalled for
further studies or biopsies by oncologic radiologists.

In light of the present knowledge and considering the probable content of
the residual closed capsules, an open or needle biopsy is not advisable.
The risks of releasing significant amounts of hazardous contamination and
possibly spreading infective entities outweighs the advantage of the
diagnostic. At any rate, such a capsule requires removal for mitigation of
symptoms and a more direct surgical approach appears more economical and
less risky.

In summary, a capsule with a dense fibro-collagenous wall behaves as a
bioreactor. Worse yet, it is fitted with a semi-permeable wall that may
periodically open to release its content to the breast. The probability of
finding the space colonized with atypical micro-organisms is elevated and
the control of infective processes by classic pharmacologic approaches is
difficult if not impossible.

Such closed capsular spaces may be comparable to "artificial organs" of
unpredictable functions. Their behavior will depend on the content and the
age of the structure, its maturity and the history of the patient. There is
a high probability that these capsules will continue to evolve for many
years, adding more layers of fibro-collagenous tissue and possibly
granulomatous material. If bacterial entities are present within the
capsule space, they can culminate in large breast abscesses with will
resist conservative treatments.

Even with less active capsules containing mostly oily and calcitic debris,
the thickening of the wall leads eventually to solid "tumor-like
structures" and are, by themselves, alarming on auscultation and self
examination. At best, such structures are unique environments for protein
denaturation and aberrant biochemical reactions with unknown long-term
consequences.

Pierre Blais, Ph.D.
Innoval 496 Westminster Ave.
Ottawa, Ontario
Canada KeA 2V1
Phone: (613) 728-8688
Fax: (613) 728-0687

12/25/01 (CNN) -- Imagine getting only three or four hours of sleep a
night for eight
years. Then having a pain as severe as a toothache throughout the entire
body at the same time. Add to that the feeling that memory is fading.

That's what life can be like for people who suffer from chronic fatigue
syndrome (CFS), says Dr. Jacob Teitelbaum, an internist who specializes in
treating this mysterious illness.
This is a serious disease that can destroy people's lives," says
Teitelbaum, who directs the Annapolis Research Center for Effective
Fibromyalgia and CFS Therapies in Annapolis, Maryland. He became interested
in the illness after succumbing to it in medical school in 1975. "There was
not even a name for it back then," recalls Teitelbaum, who says he battled
the disease for years before being cured.

Poorly understood and difficult to diagnose:
Characterized by debilitating fatigue that doesn't improve with bed rest,
chronic fatigue syndrome usually is accompanied by a number of other
symptoms, including muscle pain, weakness, memory impairment, joint pain and
insomnia, according to the Centers for Disease Control and Prevention.

The illness is thought to affect 500,000 to 800,000 Americans, according to
health officials, though some advocates say the number of sufferers is much
higher. Whatever its prevalence, the condition is poorly understood and
difficult to
diagnose. Unlike other diseases, a blood test can't determine definitively if a
patient has the condition, Teitelbaum says. Moreover, many symptoms are
common to other diseases so doctors first must rule out other explanations
for the illness. But Teitelbaum says many doctors don't recognize the
condition when they see it. He likens treatment to the early days of
multiple sclerosis and polio.
Those diseases were not immediately recognized as serious medical
conditions, he says, but dismissed as the effects of psychological problems.

As many as 90 percent of patients who have the disease have not been
diagnosed and are not being treated, according to the Chronic Fatigue and
Immune Dysfunction Syndrome (CFIDS) Association of America, an advocacy
group. The group recently surveyed 8,100 medical professionals across the
United States and found that 77 percent of them said the amount of education
doctors receive about the condition is inadequate. "Unfortunately for most
patients, the standard treatment is to be told,
'There's nothing wrong with you,'" Teitelbaum says. Other advocates agree
problems exist. "There are seriously ill patients out there who are being
dismissed as malingerers or hypochondriacs," says Jill McLaughlin,
executive director of
the National CFIDS Foundation, a grass-roots organization that works to
raise awareness and promote research of chronic fatigue syndrome.

What's in a name? One of the main reasons chronic fatigue syndrome isn't
taken as seriously as other diseases, advocates say, is the name itself.
Once a sufferer of chronic fatigue syndrome, Dr. Jacob Teitelbaum
specializes in treating patients with the illness. "No matter how much you
describe it, the name undermines every definition
you can give of the illness because fatigue isn't an illness," McLaughlin
says. "You can't convey the clinical severity of a disease whose name
connotes tiredness." Kim Kenney, CEO of the CFIDS Association of America,
agrees. Often, she says, people don't grasp the impact of the condition
until they see the dramatic change in a sufferer who was once healthy. But
there are other difficulties.

The disease was discovered in the early 1980s around the same time as AIDS.
But unlike AIDS, no causative agent such as HIV has been found that can
become a target of research, Kenney says. "There is no body count" to
capture public attention, she says. "People who die from [chronic fatigue
syndrome] -- it's often suicide that's
involved," Kenney says. "They've lost family, friends, jobs and choose not
to go on anymore."

Focus on more research: So what can be done to help people who suffer from
a debilitating condition that few doctors recognize or understand? First
and foremost, advocates say, is a need for more research. Doctors must
determine what causes the condition, a virus, immune system dysfunction,
hormone dysfunction, brain abnormalities or other factors, before they can
find a cure. In the meantime, patients have to make due with a patchwork of
treatments that target various symptoms.

Typically, patients initially are treated for insomnia since sleep
disruption often makes other symptoms worse. They're also given pain
medication and treated for any infections. Teitelbaum focuses on proper
nutrition and on regulating the activity of the
hypothalamus, a "control center" in the brain that affects sleep, hormones,
immune function and other functions. Even alternative therapies such
massage, cognitive therapy or lifestyle adjustments can be helpful, Kenney
says. But raising awareness about the nature of the disease, advocates say,
is as important as funding research and improving treatment. "It's a
serious illness. It's a complex illness. It impacts nearly every system in
the body," Kenney says. "It's worth learning more about because chances are
somebody you know is dealing with it."

12/27/01 (Reuters Health) NEW YORK:
Women treated with tamoxifen, no therapy, or radiotherapy, after undergoing
breast-conserving lumpectomy all have similar median disease-free survival
rates, Japanese researchers report.
Dr. T. Tominaga, from Toyosu Hospital, and colleagues randomly assigned 112
women, who underwent lumpectomy for breast tumors 2 cm in diameter or
smaller, to no therapy or to 20 mg tamoxifen for 2 years. For women who
received no treatment the median 5-year disease-free survival rate was
86.0% and for women receiving tamoxifen it was 78.5%, a
non-significant difference (p= 0.308). The difference in overall survival at
5 years was not significantly different between the group (92.5% no
treatment versus 94.3% tamoxifen, p = 0.745), the researchers found.

When Dr. Tominaga's team retrospectively studied 70 patients who had opted
for radiotherapy after lumpectomy, 5-year disease-free survival and overall
survival was comparable to the tamoxifen and no treatment groups combined,
according to their report in the November issue of Clinical Drug
Investigations.
Median 5-year disease-free survival rates were 82.2% in the combined groups
and 86.6% in the radiotherapy group (p = 0.352). There was also no
difference in the median overall survival between the combined groups and
the radiotherapy group (p = 0.224), they note.

"Our findings suggest that breast cancer patients may not always require
radiotherapy after breast-conserving surgery, although the generally
favorable prognosis of patients treated in this study and the low number of
tumor recurrences did not allow the equivalence of the treatment regimens to
be proved statistically," Dr. Tominaga and colleagues comment. "However,
because of this finding, and the facts that local tumor
recurrences have been reported at 10 to 15 years after radiotherapy and that
its late-onset adverse effects after 20 to 30 years are unclear, the
development of newer treatment methods to replace radiotherapy is needed."
Clin Drug Invest 2001;21:775-782.

Maggie Fox, 12/10/01: A new class of breast cancer drug seems to work even
better than
the standard tamoxifen in fighting the disease, at least in some women,
researchers said on Monday. They said it was too soon to say if the new
drugs, called aromatase inhibitors Fox says
should replace tamoxifen as a favored
drug, but they shrank tumors better and helped more women survive.
London Several studies presented at a breast cancer conference in San
Antonio show one brand of aromatase inhibitor called Femara, made by Swiss
drugmaker Novartis under the generic name letrozole, may work in a wider
range of women than tamoxifen.
"Letrozole is associated with a higher rate of tumor shrinkage, and a
better one- and two-year survival than tamoxifen," Duke University's Dr.
Matthew Ellis, who presented one study to the conference, said in a
telephone interview.

Femara is a member of a new class of drugs called aromatase inhibitors,
which work differently from tamoxifen to prevent certain kinds of breast
cancer. Tamoxifen is made under the name Nolvadex by AstraZeneca Plc but is
now available generically as well.
"It has a very simple mechanism of action that is not prone to the problems
that tamoxifen is," Ellis said. "It reduces the ability of the body to make
estrogen." About 80 percent of women with breast cancer have what is called
estrogen
receptor positive cancer - caused by the female hormone's effect on cells.

Ellis, working with researchers in Germany, Spain, France and Britain,
followed 324 women taking either tamoxifen or Femara. They saw tumors
shrink in 60 percent of women taking Femara for four months, compared to 41
percent of women taking tamoxifen. Breast cancer is the second biggest
cancer killer of women in the
industrialized world, after lung cancer. It kills 40,000 women each year in
the United States.

New drugs block estrogen better:
"Although our results are preliminary, letrozole appears to block estrogen
more effectively than does tamoxifen, suggesting that letrozole may work for
women whose tumors are relatively resistant to tamoxifen," Ellis, who is a
paid consultant to Novartis, which also funded the study, said in a
statement. In a second study, Dr. Martine Piccart of the Jules Bodet
Institute in Brussels, Belgium, and colleagues followed 453 women taking
Femara and 454 taking tamoxifen.

Overall median survival was 34 months with Femara and 30 months with
tamoxifen. Piccart said 64 percent of patients were alive two years after
starting Femara, compared to 58 percent of tamoxifen patients. Ellis' team
worked with women whose breast cancer had progressed to the late stages,
but another study presented at the conference showed a related drug,
Arimidex, could help women with early breast cancer. Made by AstraZeneca
under the generic name anastrozole, Arimidex also reduced breast cancer
deaths. After a median of 30 months' treatment and 33 months of follow-up,
317 of 3,125 women given Arimidex suffered
relapses, compared to 379 of 3,116 women taking tamoxifen - a 17 percent
reduction.

"This advance is as important for women fighting early breast cancer as the
advent of tamoxifen was 20 years ago," Michael Baum of University College
Hospital in London, who presented the results, said. "The results of the
(latest) study ... may support the use of anastrozole, rather than
tamoxifen, as the future treatment of choice," he added.

Tamoxifen mimics some of the action of estrogen and by doing so blocks its
cancer-causing effects - usually. But sometimes it does not, and tamoxifen
can increase the risk of a very rare form of cancer of the uterus. Femara
and related drugs stop the action of an enzyme called aromatase, which
converts androgen, a precursor hormone, into the female hormone estrogen.

Women taking letrozole make almost no estrogen. Tamoxifen has been shown to
reduce cases of breast cancer in healthy women who are known to have a high
risk of the disease. The researchers said it was too soon to tell if the
new drugs would have the same effect. A third company, Pharmacia, makes an
aromatase inhibitor called
Aromasin. (Personally, I was offered tamoxifen when I had breast cancer, I
read the research and refused to take it. I probably would feel the same
way about the other drugs. Women who do chemotherapy are chemically forced
into menopause, and that alone decreases dramatically the amount of
estrogen in their bodies. Lynda)

The peri-implant breast capsule: an immunophenotypic study of capsules
taken at explantation surgery. J Biomed Mater Res
2001;58(1):88-96 (ISSN: 0021-9304) Kamel M; Protzner K; Fornasier V;
Peters W; Smith D; Ibanez D Laboratory of Bone and Joint Pathology,
Department of Anatomic Pathology & Cytology, Wellesley Central Site, St.
Michael's Hospital, University of Toronto, Toronto, Canada.

Silicone-based breast implants continue to be the focus of many studies
attempting to correlate implant failure to clinical and pathological
factors. Routine pathology of peri-implant capsule is extensively described
in the literature. The actual significance of the cellular events remains
unconfirmed, particularly with reference to clinical outcome. This study
reviews our experience with explanted capsules. The study makes specific
reference to the immunohistochemistry of the cells participating in the
capsule and the significance of the immunophenotypic characterization of
these cells to clinical outcome. The use of a wide selection of
immunomarkers for T and B lymphocytes and histiocytes provided no
supporting evidence for local cell participation in the capsule, which may
indicate the presence of an immunological reaction present in the capsule
at the time of explantation. One was only able to confirm the presence of a
low-grade inflammatory process and progression to fibrosis and
calcification over time. Statistical correlation was obtained only between
Baker grade of capsular contracture and CD3/CD68 immunomarker positivity.
CD45RO did show correlation with pain. No correlation was demonstrated with
calcification. The results obtained in this study highlighted the need for
further investigations into the mechanism of histiocyte and fibrocyte
recruitment and activation in the capsule, a possible source of pain and
contracture, which is a serious long-term clinical finding leading to the
necessity for explantation.

Aetna Coverage Policy Bulletins: Subject: Breast Implants/Removal: Policy:
Aetna U.S. Healthcare covers the removal of breast implants for patients
who meet the following selection criteria.

For patients who have undergone either cosmetic augmentation mammoplasty or
breast reconstruction following a medically necessary mastectomy (e.g.,
mastectomy for breast cancer or a prophylactic mastectomy), removal of
breast implants is covered for ANY of the following indications: 1) Breast
cancer, or 2) Extruded implants, or 3) Implants complicated by recurrent
infections, or 4) Implants with Baker Class IV contracture associated with
severe pain, or 5) Implants with severe contracture that interferes with
mammography, or 6) Ruptured silicone gel-filled implants.

For patients whose breast reconstruction followed a medically necessary
mastectomy (i.e., mastectomy for breast cancer or a prophylactic
mastectomy), breast implant removal is also covered for these additional
indications: 1) Baker Class III contracture, or
2) Ruptured saline implant. Removal of ruptured saline-filled breast
implants is not covered for patients who have previously undergone cosmetic
breast augmentation mammoplasty. If any of the above coverage criteria for
removal of a breast implant is met
unilaterally, Aetna will also cover removal of the implant in the other
breast if both implants are removed at the same time. Requests for removal
of breast implants for any of the following indications should be referred
to a medical director for review: 1) Breast malposition or asymmetry; 2)
Baker Class II contracture; 3) Baker Class III contracture that does not
follow a medically necessary mastectomy; 4) Removal of breast implant due
to patient anxiety about developing an autoimmune disease; 5) Implant
removal for biopsy of breast mass that has not been proven to be cancerous; or
6) Implant removal for a mastectomy or lumpectomy that can be performed
with the implant in place.
Silicone implant removal for autoimmune disease: Aetna U.S. Healthcare does
not cover any of the following because an FDA panel concluded that there
was no convincing evidence linking silicone implants to the development of
autoimmune disease:

1) Removal of silicone implants for autoimmune disease unless the patient
meets one or more of the selection criteria listed above (e.g., rupture of
silicone-gel filled implant, etc.); 2) IgG testing in connection with
silicone implants (the development of IgG antibodies is neither specific to
silicone implants nor indicative of autoimmune disorders).

Reinsertion of breast implants: Although Aetna U.S. Healthcare covers the
removal of breast implants for medical indications even if the implants
were originally inserted for cosmetic purposes, Aetna will not pay for the
reinsertion of new breast implants in this situation. We will provide
coverage for insertion of initial breast implants and for the replacement
of breast implants inserted following a medically necessary mastectomy
(i.e., mastectomy for breast cancer or a prophylactic mastectomy).

Baker Classification: Class I augmented breast feels soft as a normal
breast, Class II augmented breast is less soft and implant can be palpated,
but is not visible, Class III augmented breast is firm, palpable and the
implant ( or distortion ) is visible, Class IV augmented breast is hard,
painful, cold, tender, and distorted.

Application to Products: Unless indicated otherwise above, this policy
applies to all fully insured Aetna U.S. Healthcare HMO, POS and PPO plans
and to all other plans, unless a specific limitation or exception exists.
For self-funded plans, consult individual plan sponsor benefit
descriptions. If there is a discrepancy between this policy and a
self-funded customer's plan of benefits, the provisions of the benefits
plan will govern. With respect to fully insured plans and self-funded
non-ERISA (e.g., government, school boards, church) plans, applicable state
mandates will take precedence over either. Unless otherwise specifically
excluded, Federal mandates will apply to all plans. With respect to
Medicare and Medicaid members, this policy will apply unless Medicare and
Medicaid policies extend coverage beyond this Coverage Policy Bulletin.
HCFA's Coverage Issues Manual can be found on this website:
www.hcfa.gov/pubforms/06_cim/ci00.htm

Washington, 11/19/01 (AP): Major reversal on product originally deemed too
risky. The Food and Drug Administration made an unprecedented about-face
Monday, approving a gel that promises less internal scarring for women
undergoing certain surgeries even though regulators originally deemed the
product too risky. A study of 281 women found 5.6 percent of Intergel
recipients suffered an infection at the surgical site, versus just 2.9
percent of women who received standard surgical treatment, the FDA
warned. THE FDA had initially rejected Lifecore Biomedical Inc.'s
Intergel, which promises to reduce internal scarring from certain
gynecologic operations.
The reason: In studies, women given the gel during open pelvic surgery had
only one fewer internal scar but almost twice the risk of infection as
women given standard treatment. Lifecore argued that Intergel was better
than that, citing study results that suggested even if women did have
internal scars, they were smaller and less severe when their surgeons used
the lubricating gel.

So Lifecore became the first company to test a new law ordering the FDA to
allow appeals without making manufacturers go to court. The government
picked a panel of independent scientists to review the Intergel decision.
These mediators ruled in September that the FDA had erred and should
approve Intergel and the agency did. Still, the FDA's approval
announcement was lukewarm at best. The agency called use of Intergel
"reasonably safe," and provided surgeons with a list of warnings
restricting how it should be used.

The gel, formally named Gynecare Intergel Adhesion Prevention Solution, is
intended to reduce adhesions, internal scar tissue that can cause chronic
pain or intestinal obstruction. Various adhesion-preventing treatments
already are sold, but Intergel is the first liquid one. It is only for use
during open gynecologic operations not the increasingly common "keyhole"
surgeries where doctors operate through a small incision, the FDA warned.
Nor is it for women with abdominal or pelvic infection, or
who have cancer or are pregnant.

Also, the FDA warned, a study of 281 women found 5.6 percent of Intergel
recipients suffered an infection at the surgical site, versus just 2.9
percent of women who received standard surgical treatment. "We don't care
how it got approved, we just care that it got approved," responded Lifecore
President Jim Bracke. "They'll be watching us carefully for safety and
that's fine. It'll prove out."

The FDA's mediators ruled that agency scientists used too harsh a
statistical interpretation in judging Lifecore's U.S. studies, and wouldn't
consider better data from Europe, where the product has been sold for
several years. The case shows the government established "a fair and
impartial appeals mechanism" and "that industry could get a fair shake,"
said FDA ombudsman Les Weinstein, who arranged the potentially
precedent-setting appeal. He said he was surprised that no other companies
have sought similar mediation. But one veteran FDA watcher called the
Intergel saga "a very dangerous precedent," questioning why outside
scientists who reviewed the product for one day were trusted more than
FDA's own scientists who had pored over Lifecore data for months. FDA
rejects few medical products, and "needs to be strong enough to stick with
its guns" when it does, said Dr. Sidney Wolfe of the consumer advocacy
group Public Citizen. Intergel should begin selling in February and cost
about $200, said Minnesota-based Lifecore.

CHICAGO, Nov. 26 - The Associated Press and Reuters contributed to this
report: A new technique may allow women who have had a cancerous lump
removed from a breast to complete radiation treatment in a single session,
without the six straight weeks or more of therapy now required, researchers
reported Monday. The experimental treatment could make lumpectomy, a
breast-saving type of cancer surgery in which only the lump is
removed, available to many more women who would otherwise have to undergo
mastectomy, or removal of the entire breast.

"If this new technique is proved effective, it should make lumpectomy
available to many more patients," said Dr. Jayant Vaidya, a surgeon at
University College London in England who led the study. "Early tests are
promising." Many women who are diagnosed with early breast cancer decide
against a lumpectomy because they cannot spend six weeks receiving daily
radiation treatments, he said. Mastectomies typically do not require
radiation. Mastectomies are often the only option for women who live far
from cancer treatment centers or find the standard radiation schedule
unworkable.

Concentrated radiation dose: An experimental technique called
intra-operative radiotherapy uses a miniature radiation probe right after a
lumpectomy. The probe is inserted inside the cavity created by the removal
of the tumor, and radiation equivalent to six weeks of doses is emitted for
about 25 minutes. The technique was just as effective as six weeks of
radiation in preliminary results from Vaidya's study of 29 women, which was
prepared for presentation at a meeting of the Radiological Society of North
America.

The women all underwent lumpectomies for tumors of less than about 1½
inches. About half got the single dose and half received the standard six
weeks of radiation. All have remained cancer-free during 1½ years of
follow-up. Since peak time for cancer recurrence is two to four years
after treatment, it is too soon to call the technique a success, said Dr.
LaMar McGinnis, senior medical consultant for the American Cancer
Society. But "so far, so good," Vaidya said.

Jeffrey Tobias, a tumor specialist at University College London, said: "We
believe this is going to work. Most cancer recurrences occur immediately
adjacent to the tumor - an area which receives radiation with this method."
Dr. Paula Schomberg, a Mayo Clinic radiologist, said the approach requires
more study. "It would certainly be advantageous if there was some way to
replace an extended course of radiation with a shorter course, for patient
convenience," she said. "It remains to be seen whether it's safe to do that."

The report said the technique is not sufficient for a form of breast cancer
called lobular carcinoma, which accounts for up to 15 percent of all breast
cancers. Vaidya said victims of such cancer still need an extended
period of radiation but the radiating sphere can be used initially.

Westport, CT (Reuters Health) 11/06/01: Obesity and smoking significantly
increase the risk of complications following transverse rectus abdominus
myocutaneous (TRAM) flap breast reconstruction, according to a report
presented at the 70th annual scientific meeting of the American Society of
Plastic Surgeons in Orlando, Florida. Active and former smoking and
obesity are linked to significantly higher rates of single and multiple
flap complications," Dr. Ivica Ducic of Georgetown University in
Washington, DC told Reuters Health. He and colleagues retrospectively
analyzed the risk factors associated with donor site and flap complications
in 224 women who underwent pedicled TRAM flap breast reconstruction over a
period of 10 years.

Obesity is a significant risk factor for overall donor site and flap
complications, as well as multiple flap complications, delayed wound
healing and minor flap necrosis, Dr. Ducic noted. Fifteen percent of the
women in the study were obese (BMI over 30). Another 38% were overweight
(BMI between 25 and 30), but Dr. Ducic's team found that being overweight
was not a significant risk factor for any complications. "Active smoking
significantly increases the risk of multiple flap
complications, flap infection, and delayed wound healing," Dr. Ducic said.
The researchers identified 15.5% of the women as current smokers. Dr.
Ducic's group also found an increased risk of multiple flap complications
and delayed TRAM wound healing in the 17.5% of women who were former
smokers, which was defined as not smoking for at least 4 weeks. The
investigators identified no significant risk factors for any complication
from presurgery radiation and chemotherapy or the use of double pedicled
TRAM flaps. "TRAM is a reasonably safe procedure in properly selected
patients," Dr. Ducic told Reuters Health. These findings suggest that
physicians could help patients reduce their risk factors by counseling them
to quit smoking and to reduce their BMI to below 30 before undergoing TRAM
flap breast reconstruction.

11/16/00, Delayed Diagnosis for Ovarian Cancer Can Cost
Lives: Symptoms Exist, but Both Patients
and Doctors Often Ignore Them. Elaine Zablocki
WebMD Medical News, Reviewed by Dr. Pamela R. Yoder: Vague symptoms, such as
abdominal bloating and gastrointestinal upset, may be a sign of ovarian
cancer and should not be ignored, according to a study in the Nov. 15 issue
of Cancer.

Ovarian cancer is often called a "silent killer,"
according to study author Barbara A. Goff, MD, who is
with the University of Washington department of
obstetrics and gynecology in Seattle. She writes that
the disease is usually not detected until
an advanced stage because it has been
thought that most women with ovarian cancer don't have
specific symptoms. In fact, ovarian cancer does produce
symptoms, but both patients and doctors may not give
them proper attention.

Goff and colleagues surveyed more than 1,700 women with
ovarian cancer and found that 95% of them did experience
symptoms before their diagnoses, most often
increased abdominal size, abdominal bloating, abdominal
pain, and fatigue. Other symptoms included indigestion, constipation, back
pain, and change in urination frequency. Most importantly, only a quarter
of the women experienced specific pelvic symptoms, such as pelvic pain or
pain with intercourse.

Today, all women know that a breast lump is a warning sign for breast
cancer, something you don't ignore. Now women need to become aware that
vague abdominal symptoms possibly could point to an ovarian tumor or the
spread of a cancerous tumor. About one in five of the women who took the
survey ignored their symptoms at first. When the women did go to see the
doctor, 30% said they had been given an incorrect diagnosis such as stress,
depression, or irritable bowel syndrome. Still, more than half of them did
get a correct diagnosis in less than three months from the time they first
talked to the doctor; 11% waited more than a year.

One in five of the surveyed women believed doctors' attitudes toward their
symptoms were a barrier to accurate diagnosis. Among the women who weren't
diagnosed for more than a year, almost half felt one of the reasons was
their provider's attitude. "Women must pay attention to these symptoms and
go to a doctor if they have them. Consumers sometimes have to be an
advocate for themselves," says Anil Sood, MD, assistant professor of
gynecologic oncology at the University of Iowa College of Medicine in Iowa
City.

James Fiorica, MD, agrees. "The message from this study is, don't ignore
these symptoms. Don't assume it's just some virus. See your physician and
ask if these symptoms could be due to ovarian cancer." Fiorica is program
leader of the gynecologic oncology program at the H. Lee Moffitt Cancer
Center and Research Institute and professor at the University of South
Florida, both in Tampa.

A pelvic exam is one of the most valuable tools we have to diagnose ovarian
cancer, say both Fiorica and Sood. It allows the physician to feel with the
fingers to see whether there's an ovarian mass. It helps the doctor decide
whether further tests, such as ultrasound, are needed. A pelvic exam must
probe the rectum as well as the vagina, Sood emphasizes. "You can miss 25%
of ovarian masses if you don't do a rectal exam. Of course, not every woman
with abdominal bloating will turn out to have ovarian cancer. Still, a
pelvic exam, including a digital rectal exam, is such a simple thing to do.
It should be part of every good physical exam." However, about a third of
the surveyed women said when they first discussed their symptoms with the
doctor, no pelvic exam was done. "Physicians need to comprehend the
potential significance of these symptoms," Sood says. "If a woman finds her
doctor doesn't perform a pelvic exam, she should feel free to seek out
someone who does." "It is so critical that patients not ignore this,"
Fiorica says. "At a bare minimum, have a pelvic done. Then the physician
can decide if anything additional is needed. If we take these steps,
hopefully we can detect these cases earlier, and cure more of them."

NY 10/31/01 (Reuters Health) Merritt McKinney: Scientists announced on
Wednesday that they may have identified how the autoimmune disease lupus
destroys the central nervous system. Antibodies produced by the disease
seem to kill nerves by latching on to a receptor on neurons, according to a
report in the November issue of the journal Nature Medicine. The discovery
eventually may lead to new therapies for the disease, one of the
investigators told Reuters Health. In people with lupus, or systemic lupus
erythematosus (SLE) as it is officially known, the immune system loses the
ability to differentiate between its own cells and outside invaders, and
antibodies attack healthy cells. The condition can vary widely in severity,
manifesting as skin rash and arthritis or leading to damage to the kidneys,
heart, lungs and brain to varying degrees. There is no cure. The disease
disproportionately affects women, particularly those of childbearing age
and of African or Asian descent. If the central nervous system is affected,
the resulting damage can cause a variety of problems including headache,
paranoia, mania, schizophrenia and stroke. Exactly how lupus antibodies
kill nerve cells has been a mystery, however.

Now Dr. Betty Diamond, of Albert Einstein College of Medicine in New York,
and colleagues have discovered in experiments with human tissue and mice
that lupus antibodies latch on to a common receptor found on nerves. Once
the antibodies attach to these receptors--known as the NR2 subunits of the
NMDA receptor--they trigger the death of neurons. The research eventually
may lead to new therapies for lupus, one of the study's co-authors told
Reuters Health. "New insights into disease mechanism often lead to new
therapeutics," said Dr. Bruce T. Volpe, of the Burke Medical Research
Institute of Weill Medical College of Cornell University in White Plains,
New York. "Our work suggests a new hypothesis for the clinical symptom of
cognitive decline in patients with lupus," he said. "Now we need to test
it. "He explained that the antibodies "cross react" with ordinary molecules
in the body, meaning that they recognize the molecules by mistake. This
"accidental recognition" may destroy the cell, Volpe said. Now that
researchers have formulated a new hypothesis about how lupus damages the
nervous system, there are many questions to answer, according to Volpe. The
next steps, he said, include seeing how frequently the nerve-killing
antibodies are present in people with lupus and whether the presence of the
antibodies is linked to neurological symptoms. It will also be important to
find out whether the process of cross-reactivity, or accidental
recognition, is involved in other immune diseases that affect the nervous
system, Volpe said. The authors of an accompanying editorial agree that the
research may open the door to new treatments if it is confirmed. And future
research may show that similar types of "cross-reactivities" also play a
role in other types of lupus-related tissue damage, according to Drs. Brian
L. Kotzin and Elizabeth Kozora, of the University of Colorado Health
Sciences Center in Denver. But the editorialists caution that the results
of the experiments, which included samples from only a few lupus patients,
are preliminary. Source: Nature Medicine 2001;7:1175-1176,1189-1193.
Westport, CT (Reuters Health) 10/01/01 Women with implanted medical devices
are more likely to develop undifferentiated connective tissue disease
(UTCD) than women without these devices, according to a report published in
the American Journal of Epidemiology for October 1. Previous studies have
failed to find a link between silicone-containing implants and specific
autoimmune diseases such as scleroderma or other rheumatic diseases, the
authors note. However, the statistical power of many of these studies may
have been limited in that relatively rare diseases and exposures were examined.

In the current study, Dr. David Schottenfeld, from the University of
Michigan at Ann Arbor, and colleagues compared the device exposure history
of 205 women with UTCD with that of 2095 control women without such
disease. Women who had received any type of silicone-containing device were
2.81 times more likely to develop UTCD than women who had not received a
device, the authors state. An elevated risk was noted with silicone breast
implants, in particular, but the association was not
significant. Implantation of non-silicone-containing devices was also
associated with a significantly increased risk of UTCD, the researchers
note. In fact, women who had received artificial joints were 5 times more
likely to develop UTCD than those who had not. On average, women had
received their implant at least 4 years prior to developing UTCD, the
investigators point out. There was a "suggestive relation" between duration
of exposure and incremental risk of UTCD. Am J Epidemiol 2001;154:610-617.

April 18, 2002: A new report by a panel of international experts casts
doubt on long-standing claims that hormone replacement in postmenopausal
women can prevent or treat a variety of ills, including heart disease,
Alzheimer's disease, major depression, urinary incontinence and broken
bones due to osteoporosis. While hormone therapy is the most effective way
to relieve menopausal
symptoms such as hot flashes and night sweats, scientific evidence is
insufficient to support its use for the other problems, according to the
report, which is to be published in June. And the hormones have
well-documented drawbacks, including an increased risk of blood clots and
gallbladder disease and, with prolonged use, breast cancer.

About 20 percent of women who reach menopause naturally use hormone
replacement at least temporarily, according to the North American Menopause
Society. The figure is higher for women who reach menopause early because
of surgery to remove their ovaries. Hormone replacement usually consists
of estrogen plus another hormone, progestin, or, for women who have had
hysterectomies, estrogen alone.

Given the known risks and limited benefits of hormone treatments, the
report says, each woman and her doctor should weigh her medical history
carefully in deciding whether she really needs it. Drugs to lower
cholesterol and blood pressure are better for reducing the risk of heart
disease for many women, and other nonhormonal drugs work better in
preventing fractures. That advice departs from decades of medical practice:
Many women and their doctors assumed that taking estrogen at menopause was
a way to preserve youth and health.

American women spent $2.75 billion on hormone replacement in 2001,
according to IMS Health, a company that tracks drug sales. Premarin, a form
of estrogen replacement therapy, was the third most commonly prescribed
drug in the United States last year with more than 45 million prescriptions
dispensed. The new report, called the International Position Paper on
Women's Health and Menopause, was financed by the National Institutes of
Health and the Giovanni Loren Zini Medical Science Foundation of
Italy. The full report, which is book-length, is to be issued by the
National Heart, Lung and Blood Institute, but the chapter on hormone
replacement and other treatments was published early and distributed at a
symposium at the National Institutes of Health. Researchers who worked on
the report said some of its findings might shock doctors and patients.

Dr. Vivian Pinn, director of the NIH Office of Research on Women's Health
and a co-editor of the report, said many people, including doctors, had
believed that hormone replacement would prevent heart disease and strokes
and help women live longer. But, she said, "as we're learning more from
long-term studies and better defined studies over the past few years, all
these things we've thought about the wonders of hormone replacement may not
be holding up under scrutiny." Dr. Nanette Wenger, chief of cardiology at
Grady Memorial Hospital in Atlanta and editor of the report, said that
until fairly recently many doctors simply told women: " 'Take this. You'll
look better. You'll feel better.' People acquiesced. There was no
questioning." "Given the fact that hormone replacement has been around for
half a century, it's really only in the last decade that we've begun to get
stringent scientific evidence from randomized controlled trials," Wenger
said. "And in many areas there have been enormous surprises."
For instance, Wenger said, three recent controlled trials have found that,
rather than protecting women from heart attacks and strokes, hormone
replacement increases their risk.
Last year, the American Heart Association said women should not regard
hormone replacement as a means of treating or preventing heart disease.
Even though hormones can help lower bad LDL cholesterol and raise good HDL
cholesterol, the group said statin drugs were far better at doing
so. Hormone replacement can prevent bone loss from osteoporosis, and some
studies have suggested it reduces the risk of fractures. But bone loss
resumes after a woman stops taking hormones. Moreover, no large randomized
controlled trials have determined whether the treatment reduces fractures.
The Food and Drug Administration has approved hormone therapy to prevent
osteoporosis, but not to treat it.

Wenger said doctors had long assumed that hormone replacement would help
older women who suffered from urinary incontinence. "But now two trials
show no improvement, and there may be a worsening," she said. "So many of
the earlier presumptions, as they come to trial, do not show evidence of
benefit," Wenger said. Dr. Deborah Grady, a professor of epidemiology and
medicine at the University of California San Francisco, said, "A decade ago
I thought preventive hormone therapy should probably be prescribed to most
postmenopausal women, except those at high risk for breast cancer." As
lead author of the 1992 guidelines on hormone replacement for the American
College of Physicians, she incorporated that view into the guidelines. But
now, she says, "there have been major changes in the way we use hormone
therapy." Today, Grady said, "rather than prescribing it for most
postmenopausal women, I prescribe it for symptoms, for which it is far and
away the best treatment."

ALTERNATIVE MEDICINE: San Diego, CA (AP) -- Studies exploring the effects
of specific foods on the brains of animals found that diets rich in spinach
and blueberries may help stave off age-related declines in rats' mental
abilities. Rats fed a diet rich in spinach reversed a normal loss of
learning that occurs with age, according to a study by researchers at the
University of South Florida. The study was presented at the Society for
Neuroscience's annual meeting in San Diego this week.

Rats fed a normal diet that contained 2 percent freeze-dried spinach
learned to associate the sound of a tone with an oncoming puff of air
faster than those fed regular rat chow, the study found. The test measured
the interval between the sound of the tone and when the rats blinked, and
was designed to test the ability to associate two distinct but related
events. The speed of the reaction has been shown to decline with age in
rodents, rabbits and humans. Spinach is rich in antioxidants, which
scientists say can block the effects of free radicals. Studies suggest the
lifelong accumulation of free radicals in the brain is linked to mental
declines in old age and is also a probable factor in Alzheimer's and
Parkinson's diseases. "This is a preclinical finding of significant
interest that now needs to be tested in humans," said Dr. Paula Bickford of
the University of South Florida, an author of the study.

Blueberries are also rich in antioxidants. A study by researchers at the
University of Houston at Clear Lake and the Universidad Nacional Autonoma
de Mexico found that blueberries may help fight age-related declines in
rats' memories. Aging rats that were fed a blueberry-supplemented diet for
four months tested as well as younger rats in their abilities to recognize
objects after an hour. Aging rats fed a normal diet failed to recognize the
objects. "This research has rather hopeful implications for prevention of
neurological or psychological disorders in our increasingly aging
population," said Dr. David Malin of the University of Houston, Clear Lake.
The brains of the rats in the experiment are being analyzed to determine
whether blueberries slowed brain degeneration.

Fat-fighting fat shows promise: from Consumer Reports on Health, 06/01. The
supposed wonder fat is conjugated linoleic acid (CLA), a type of
polyunsaturated fat found, in small amounts, in dairy products, beef, and
other meats. It's also widely available in several major brands as a
concentrated dietary supplement (Nature Made CLS and Nature's Way Tonalin
XS-CLA) sold in health food stores and via the Internet. Numerous studies
in animals have shown that CLA can help make them leaner by reducing body
fat, increasing muscle mass, or both. Now studies are starting to show
that the pills may work in humans, too.

In a clinical trial published in the Journal of Nutrition, Norwegian
researchers randomly assigned 60 overweight volunteers to take either CLA
supplements or placebo pills; all were encouraged to exercise but told not
to diet. After 12 weeks, two of the three higher-dose CLA groups had lost
significant amounts of body fat (6% and 4%, respectively). Overall, the
CLA groups lost more fat (though not significantly more weight) than the
placebo group.

A second clinical trial, not yet published, found that taking 3 grams of
CLA daily for six months helped people who were dieting and exercising not
only lose fat but also build muscle. That's important, since dieting tends
to eliminate muscle along with fat, that lose of calorie-hungry muscle can
undermine efforts to maintain weight loss by lowering the body's
metabolism, or basic calorie-burning rate. And replacing fat with muscle
can make you look slimmer even if you don't lose weight.

Researchers theorize that CLA may work either by helping to draw fat out of
the body's fat cells or by inhibiting their incorporation of additional
fat, thereby redirecting food calories into muscle rather than fat cells.

Of course, a few small, relatively brief human studies are hardly enough to
establish that CLA can help overweight people retool their
physique. Moreover, the optimal formulation and dosage of the pills as
well as their long-term safety are unknown. So while CLA looks promising
for trimming down (and possibly other health benefits, too), our
consultants say there's not enough human research to warrant recommending
the pills.

Also from Consumers Reports on Health 05/01: Green foods for the eyes:
Eating lots of leafy greens may help you keep seeing clearly as you age,
according to two recent studies. Previous research has tentatively linked
the destructive chemical process known as oxidation to cataracts, or
clouding of the lens of the eye. The recent studieseach from researchers
at Harvard, roughly a decade long, and including tens of thousands of
peopletend to bolster that link.

The studies found that men and women with the highest dietary intake of the
plant substances lutein and, to a lesser extent, zeaxanthin, had roughly a
20 percent lower risk of serious cataracts. (Lutein and zeaxanthin are
cousins of betacarotene, all in the carotenoid family; they're the only
carotenoids found in the lens of the eye.) Further, the studies linked
spinach and either kale or broccoliall high in luteinwith reduced cataract
risk.

Those findings bolster the argument for eating plenty of highly nutritious,
dark-green vegetables. However, it's too soon to recommend taking lutein
supplementsa lesson learned from the betacarotene saga, where research has
found benefits from the carotenoid in foods but usually not in pills.

Genitourinary syndrome and fibromyalgia: by R. Paul St. Amand, M.D. , 4560
Admiralty Way, Suite #355, Marina del Rey, CA. 90292 (310) 577-7510: Over
the course of some forty years, treating the entity Fibromyalgia, we had
documented that many of our women patients had repeated bouts of vaginal
and urethral symptoms. Since these symptoms like the rest responded to our
treatment of we did not think in terms of a separate syndrome. Fibromyalgic
individuals complain a lot. Ordinarily, the most overwhelming symptoms
are the aches and pains striking anywhere in the musculoskeletal system.
They are devastatingly tired, nervous, tense, irritable, depressed, awaken
frequently and cannot get back to sleep; all this is accompanied by poor
memory and concentration forcing re-reading of material simply to grasp its
gist. Very commonly, headaches arise from the back of the occiput
and neck, sweep over to the front, frequently involve but
one-half though frequently, all of the head. Often present are:
dizziness, experienced as a fleeting, wavery sensation but sometimes true
spinning, known as vertigo; eye complaints of irritation such as dryness
and perhaps morning mattering and excessive tearing; blurring for a few
minutes often requires repeated re-focusing. Occasionally, rapid twitching
of the eyelids (blepharospasm) is felt. Flushing and sweats are common as
are nasal congestion, bad or metallic tastes, ringing or fluttering sounds
in the ears, numbness anywhere but often only of the hands and feet.
Patients are often diagnosed with the "irritable bowel syndrome" or
"spastic colon" which consist of gas, bloating, nausea in waves, cramps and
alternating constipation or diarrhea.

In addition to the above, women will often note burning on urination,
persistent or fleeting, and vaginal irritation or discharge. If pelvic pain
level allows intercourse, vulval or introital chafing, rawness or burning
follows. Excessive vaginal mucus often follows and may permit a medium for
frequent yeast infections. Others may suffer repeated bladder infections.
At other times, similar symptoms arise but urinalyses are clear and no
bacteria can be cultured. These people are often told they have
"interstitial cystitis." This cluster of symptoms is now known as "Vulvar
Pain Syndrome (VPS)" or Vulvodynia. A subset of these women have a more
specialized complaint called Vestibulitis, or vulvar vestibulitis-which
refers to pain and irritation in the area of the entrance to the vagina. In
my experience, all the women I have examined with the Vulvar Pain Syndrome
have had Fibromyalgia.

After forty years in working with Fibromyalgia some things seem apparent. I
think it is inherited, mainly effects women (80% of patients) and has
scattered effects over most of the body. I also think this is an illness
caused by the excess accumulation of something which causes affected cells
in any given system to malfunction. Since this situation occurs almost
anywhere and involves many locales at once, multiple symptoms evolve. I
suspect that the abnormality is chemical and merely due to the excess
retention of some normal body constituent(s) which evoke no inflammatory
response and, initially, no permanent damage. Therefore, all laboratory
tests and X-rays are normal.
I assume Fibromyalgia is caused by one or more defective genes since I have
treated as many as three generations of some families with this diagnosis.
It is unusual not to obtain a history of similar complaints or of
osteoarthritis in older family members.
So common is this information as to make me suspect that osteoarthritis is
often the natural sequel of long-standing Fibromyalgia. Some mutations seem
more rapidly symptomatic than others and cause symptoms in early life.
Other, less-impacting, genetic alterations only slowly effect patients at
very variable ages and levels of severity. Thus we have treated five
four-year old children, several others in the pre- teens but most patients
are more mature at onset. The youngest usually have a bilateral family
history of Fibromyalgia, "rheumatism" or osteoarthritis. There is often a
history of growing pains as a child, "migraine" headaches in the teens and
progressive aching in highly variable cycles after that. At first, long
gaps between attacks are usual causing physician and patient to miss the
connection. Eventually, symptoms merely cycle from bad to worse and allow
no more good days. Many people have been diagnosed as having "chronic
fatigue syndrome," EBV infection, systemic candidiasis etc. All we have
seen, so-grouped, have been fibromyalgic.

My approach to this illness is controversial. It is not the
conventional one outlined and followed by rheumatologists. I do not follow
the diagnostic guidelines of eleven out of eighteen predetermined, tender
points since it is usual to find many more, several not in the anticipated
locations. I definitely do not agree with the accepted treatment approach
since that is mostly an attempt to control symptoms. Though I cannot change
our genetic makeup, I believe we are attacking at the next, best level: the
proximal cause of the illness, and by that, seeking ultimate,
maximally-obtainable relief.

Once my patients helped me stumble into an effective treatment
for Fibromyalgia it seemed proper to form a theory to fit the
results. However incorrect this might prove later, I present the
following. It is my suspicion that the defective genes cause retention of
something that should be excreted by the kidneys in sufficient amounts to
maintain appropriate, inner cell levels. Phosphate retention is a likely
suspect though oxalates or other normal metabolites could be culprits or
accomplices. We have tested twenty-four hour, urine collections before and
after instigating treatment in a few patients. An increase mainly in the
excretion of phosphate but also of oxalates and calcium occurred. My
theory, simplistically stated, is that minimal phosphate retention year
after year is leading to gradual excesses. An elevated phosphate in the
blood is not tolerated since it would depress calcium levels. The
parathyroid glands will not allow this and phosphate must be spread evenly
not only in body fluids but also within cells. This accumulation of
negatively charged phosphates (possibly oxalates and/or other anions)
demands retention of positively charged, cations, most probably calcium
but also sodium and possibly others. The excess intracellular phosphate
depresses formation of energy (ATP) in the cells' "power stations," the
mitochondria. Calcium is drawn into the cell's fluid compartment to
chemically buffer phosphate. This would initially cause the cell to
over-achieve its designated function. However, the cells' deprivation of
sufficient energy (ATP) would not allow extrusion of calcium from cellular
fluid into appropriate storage bins. The afflicted cell then could no
longer adequately perform its usual chores and thus, varying degrees of
cellular and system apathy develops. Afflicted individual would obviously
experience complaints referable to the obtunded areas.

We have learned that any medication used for treating gout by causing
urinary excretion of uric acid, also works for Fibromyalgia though no
connection exists between the two conditions. A gradual evolution in our
use of various agents finally led us to Guaifenesin, which has minimal
effects on uric acid and would not be effective for gout. Guaifenesin has
been used only to liquify mucus. It is present in small amounts in many
cold preparations such as Robitussin or other cold and cough preparations.
For our patients, it has proven the most effective treatment to date. In a
cyclic manner, the illness undergoes reversal several times faster than it
developed. Unfortunately this reproduces all the symptoms of the condition
that are often worse than before since this acceleration involves many
areas simultaneously. Gradually and progressively more good days appear,
cluster and finally restore the patient to normal if no permanent damage
has occurred.

Those of you with vulvodynia and the entire complex of genitourinary
symptoms are being presented with this topic for your information. We have
seen so many patients with your complaints as part of Fibromyalgia that it
would be simple for me to assume it is but one disease. However, I should
also emphasize that I am an endocrinologist, not a gynechologist---so my
experience has been limited to a degree.

We have treated a few thousand patients with Fibromyalgia, many before a
name was available for the disease. These individuals taught us the
symptoms and the approach to treatment by their own, very personal
observations. I too have this condition as do my three daughters and two
sisters--it is my father's legacy! I hasten to repeat that this treatment
is not for wimps since in most patients symptom reversal is intense.
However, health so attained becomes ever more valued since one will always
remember the years of horror. An excellent foundation supports women with
these problems. They have seminars in various parts of the country and are
well-acquainted with FM. I suggest anyone with these problems contact and
consider joining this excellent organization. The address:
The Vulvar Pain Foundation
Post Office Drawer 177
Graham, North Carolina 27253
Phone: (910) 226-0704
Fax : (910) 226-8518
http://www.vulvarpainfoundation.org

(I don't necessarily agree that fibromyalgia is heriditary, because many of
us with toxicity did not have family histories of it, but his theory and
treatment are interesting. Lynda.

Policosanol: This is something I recently discovered, so thought I would
share it with all of you. Since I had my chest dumped full of silicone, my
cholesterol has never returned to normal. This information may repeat
itself somewhat, as I gathered it from three sources.

A newly discovered supplement, policosanol, can lower cholesterol as
efficiently (and often better) than prescription drugs such as Lipitor. It
takes up to 12 weeks to show results, but there are no known side effects
(no liver damage, as can occur with statin drugs). Dosage is 2-10 mg.
tablets at nighttime. I found them at the most reasonable price in
bottles of 120 tablets (30 day supply) on a website: www.smartbomb.com

Policosanol: Taking cholesterol management to a higher level: Ten years of
research has shown that Policosanol decreases the body's production of
cholesterol and assists the removal of cholesterol from blood. Clinical
trials have proven that Policosanol can: Reduce total cholesterol levels,
Reduce LDL*cholesterol levels ie "bad", cholesterol Increase HDL
cholesterol levels, ie. "good" cholesterol, Reduce LDL /HDL cholesterol
ratios, Having balanced levels of HDL and LDL cholesterol is very important
in the maintenance of normal health cholesterol. Positive effects of
Policosanol on cholesterol levels can be expected to occur within 8 weeks.

How does Policosanol compare with other treatments? Fish oils ~ in large
doses (10-12,1 gram capsules a day),fish oils significantly reduce
triglycerides (fats in the blood), but have little effect on
cholesterol. Garlic ~ trials with garlic have been inconsistent and show
only marginal effects on cholesterol. Dosages are typically between 2 to 5
grams of fresh garlic equivalent. As margarines containing plant sterols
work on inhibiting the absorption of dietary cholesterol, they don't impact
the 75% of cholesterol produced by the body.

Policosanol: How sugar can could help reduce high cholesterol: What is
policosanol? Policosanol is a natural product, derived from the waxy
coating of sugar cane, now available to lower high blood cholesterol. What
is policosanol's effect on cholesterol? Policosanol has been shown to be
effective in lowering both total cholesterol and low density lipoprotein
(LDL) cholesterol, the so-called 'bad' cholesterol. It has also been shown
to increase levels of the 'good' type of cholesterol, high density
lipoprotein (HDL) cholesterol. Why is LDL cholesterol important? The level
of LDL in a person's blood is linked to atherosclerosis (narrowing of the
blood vessels due to build up of lipids, sometimes known as 'hardening of
the arteries'). Having a high level of LDL cholesterol puts a person at
risk of having coronary heart disease. Why is HDL cholesterol
important? HDL is called the 'good' cholesterol as it can actually help
carry cholesterol away from the arteries to the liver, where it is
processed and excreted from the body. A relatively high proportion of HDL
in your total cholesterol level may be beneficial in reducing the risk of
coronary heart disease. Policosanol can increase levels of HDL, the good
cholesterol.

How does policosanol work? Doctors have not yet discovered the exact
mechanism of action by which policosanol lowers LDL cholesterol, but
superficially it seems to be similar to that of other cholesterol-lowering
drugs. It appears to decrease the production of cholesterol in the body and
also increase clearance of LDL cholesterol from the bloodstream. Other
effects of policosanol: Policosanol has also been shown to reduce the
stickiness of blood platelets. Blood platelets are the cells that
congregate at sites of bleeding in the body and stick to each other to form
a plug which stops the bleeding. They also release chemicals to attract
more platelets and promote formation of a clot. This is usually a
beneficial effect in the body, particularly when we are injured. This
mechanism can also contribute to the formation of clots in narrowed blood
vessels which become damaged where cholesterol and fats have built up. So,
if the blood platelets are reduced in stickiness which is what policosanol
achieves there is less chance of a clot (thrombus) forming.

How effective is policosanol at reducing cholesterol? Total cholesterol a
single daily dose of 5 mg to 10 mg of policosanol has been shown in some
studies to significantly reduce total cholesterol by between 8 per cent and
18 per cent. LDL cholesterol (bad cholesterol) in some studies a single
daily dose of 5 mg to 10 mg of policosanol reduced LDL cholesterol by
between 11 per cent and 28 per cent compared with the level before
treatment. The reduction in LDL cholesterol with 10 mg of policosanol was
comparable to results obtained with low-doses of statins a class of
cholesterol-lowering drugs, such as pravastatin and simvastatin. HDL
cholesterol (good cholesterol) in other studies a single daily dose of 5
mg to 10 mg of policosanol increased HDL cholesterol by between 17 per cent
and 29 per cent.

These results were achieved after a treatment period of 8 weeks and were
maintained when policosanol was given after that period. How safe is
policosanol? Policosanol has been used overseas for nearly 10 years. So
far, 2 large studies have looked at nearly 30,000 people taking between 5
mg and 15 mg of policosanol daily for 2 to 5 years and monitored them for
adverse effects. Only 48 patients stopped taking policosanol because of a
side effect a rate of less than one in 100. The most common side effect
was weight loss.

Is policosanol suitable for me? Professor Leon Simons, Associate Professor
of Medicine and Consultant Physician in Sydney, states: 'Given the safety
and efficacy profile, policosanol would seem to be indicated, in addition
to standard dietary advice: In patients with mild
hypercholesterolaemia; as an alternative to low dose statin; and in
situations where statins cannot be used.'

What is policosanol? It's a group of eight or nine solid, waxy compounds
(long-chain alcohols) extracted from the sugar cane that reduce cholesterol
levels. These compounds are collectively called policosanol, of which the
most prominent member is a molecule called octacosanol. Because your own
body makes much more cholesterol than you typically consume,
restricting dietary cholesterol is often an insufficient means of
regulating blood cholesterol levels.
There is a growing body of evidence demonstrating that policosanol has
benefits on a par with those of the cholesterol-lowering drugs known as
statins, the best-known examples of which are lovastatin,* simvastatin, and
pravastatin. Policosanol is very effective at lowering the blood
cholesterol in hyperlipidemic patients - individuals with high levels of
lipids (fatty molecules), such as cholesterol. It appears that policosanol
and statins function in much the same way to inhibit the natural formation
of cholesterol in your body. Thus, daily supplementation with policosanol,
as clinical research has demonstrated, results in a significantly improved
blood cholesterol profile. Happily, that generally translates into
improved cardiovascular health as well. Lovastatin occurs naturally in red
yeast rice, a traditional food of Southeast Asia. In the form of dietary
supplements, red yeast rice provides many of the benefits of the statin drugs.

Whjy restricting dietary cholesterol doesn't work. Every cell in your
body requires cholesterol to function properly. This molecule is essential
for forming cell membranes and is an important precursor for creating other
compounds, such as vitamin D (to build and maintain healthy bones), the sex
hormones (estrogen and testosterone, for example), and the bile acids (used
for digestion). Because cholesterol is so important, your liver ensures
that it is made in sufficient amounts to provide for all these functions.
In fact, your liver makes about three times as much cholesterol (normally
about 600 mg/day) as you consume in your food (the dietary recommendation
is 200 mg/day). Because your own body makes much more cholesterol than you
typically consume, restricting dietary cholesterol is often an insufficient
means of regulating blood cholesterol levels. Restricting your fat intake
is far more important, because fats are the primary source of the
cholesterol your body produces.

COMMENTARY: Dr. Zuckerman's Testimony, House Committee on Energy and
Commerce 11/15/01: My name is Dr. Diana Zuckerman and I am president of
the National Center for Policy Research for Women & Families. Our
organization is a nonprofit think tank dedicated to improving the lives of
women and families by explaining and disseminating medical and scientific
research information.

I am honored to be on this panel with Congressman Roy Blunt and these
courageous women, to talk about the need for H.R. 1961, a bill that will
help to ensure and protect women's health and well being. The Breast
Implant Research and Information Act calls for more research on breast
implants. I am here to tell you why this bill is so essential. Breast
implants have been sold in this country for almost 40 years, but we still
know very little about their long-term health risks. In fact, almost a
million women had breast implants before the first epidemiological study
was published about health risks. Before then, there were just a few
studies of rats and dogs, but no published studies of human beings.

In 1990, as a scientist working on what is now the House Reform and
Oversight Committee, I started an investigation of the FDA's regulation of
breast implants. We found that the FDA had ignored the concerns of its own
scientists by allowing the sale of breast implants without requiring that
the manufacturers prove that implants were safe. As a result of our
hearing, the FDA finally required the manufacturers to submit studies of
silicone gel implants. Unfortunately, those studies were so badly designed
that they could not prove whether or not implants were safe.

In response to pressure on both sides, the FDA did something they almost
never do - they refused to approve implants but allowed them to stay on the
market as a "public health need." I think the last two months have shown
us what a true public health need is - and breast augmentation does not
qualify. But, at the time, Congress went along with the FDA decision, but
required the NIH to conduct long-term research.

There were no studies of women with implants in 1990, but quite a few
epidemiological studies have been conducted since then. I have read all of
them. Despite what you may have heard in the media, the research and the
report by the Institute of Medicine does not conclude that implants are
safe -- to the contrary, they show many serious problems related to
implants. In fact, just a few months ago, three major new studies
reported that women who have breast implants are at significant risk for
several debilitating and fatal diseases.

One study, conducted by researchers at the National Cancer Institute (NCI)
reported that women with implants were more likely to die from brain
cancer, lung cancer, other respiratory diseases, and suicide compared to
other plastic surgery patients. A second study, also by NCI, reported
that women with breast implants are more likely to develop cancer compared
to other women their age. Both of these studies were of women who had
either silicone or saline breast implants for at least 8 years. In
contrast, the studies showing no increase in disease for women with
implants included many women who had implants for short periods of time -
even as short as one month. Obviously, cancer and autoimmune diseases do
not develop that quickly. A third study, conducted by scientists at the
FDA, found that women with leaking silicone gel breast implants are more
likely to have several painful and potentially fatal autoimmune
diseases. Implants were found to be increasingly likely to break as they
got older, and most implants were broken by the time they were 10-15 years
old. This study may provide an important clue: it is possible that
illnesses reported by women with implants are a result of leaking implants
- which would explain why most women do not have systemic health problems
until after they have had implants for several years.
At the same time that these new studies were released, the plastic surgery
organizations announced that almost 300,000 American women got breast
implants last year, most of them for augmentation. Although they don't
boast about it, their statistics also show that the number of teenage girls
getting implants has more than doubled in the last 3 years. These three
new studies remind us that, although relatively few women become ill after
having implants for a year or two, we need to be concerned about the
long-term dangers. And women who are considering implants deserve to be
accurately informed about the risks -- what is known, and what is not
known. And yet, hundreds of thousands of women are deciding to get
implants because they mistakenly believe that implants are proven safe for
long-term use.

The two studies conducted by NCI were mandated by Congress. They were
designed to answer two essential questions:
1) do breast implants increase health risks and 2) do women with implants
die at a younger age than other women? These are still the essential
questions and that is the purpose of H.R. 1961. I am especially pleased
that this legislation requires studies of women with implants after
mastectomies. It is unfortunately true that not one single breast cancer
patient was included in the studies that the federal government has
conducted thus far. I want you to know that Congress requested that
mastectomy patients be included in those studies, but the head of NIH at
the time, Dr. Bernadine Healy, refused. It's too late to fix those
studies, but it is absolutely essential that studies of reconstruction
patients be conducted as soon as possible. At this point, most of what we
know is based on the manufacturers' own studies, which show that one in
four reconstruction patients need to have at least one additional surgery
within the first three years after getting saline implants, and that other
complication rates are also extremely high. We need to know what happens
after three years, and we need to tell breast cancer patients about these
complications so that they can make an informed decision about what would
be best for them.

In addition to new studies, it would be very cost-effective for the NIH to
continue to study the breast augmentation patients in the NCI and FDA
studies that I described a few minutes ago. At the time the NCI studied
the women's medical records, they had implants for at least 8 years. They
have now had implants for at least 11 years, so it is important to study
what has happened - whether the cancer rates, autoimmune diseases, and
death rates of women with implants have increased or decreased in the last
three years.
Although I am especially concerned about the lack of information about the
long-term safety of reconstruction, I m also concerned about the thousands
of teenage girls that are getting breast implants every year. We don't
know what will happen to those girls, but unfortunately neither they nor
their parents realize how little is known about long-term risks. It is
time we answered that question. And H.R. 1961 would help ensure that
patients -- and teenage patients' parents -- know what the risks are well
before they decide whether or not to get implants.

In conclusion, I want to thank the Committee for holding this hearing, and
especially thank Congressman Blunt and Congressman Gene Green for their
essential work on this legislation. And, I thank the Committee members
who have supported this legislation and shown respect and support for their
constituents who have courageously shared their experiences with
implants. We need your continued help. If Congress doesn't require that
these important studies be conducted by NIH, it is unlikely that they ever
will be. And so, we're counting on this Committee to make sure that NIH
moves forward as quickly as possible.

I hope the Committee will also undertake a careful review of the role of
the FDA regarding the lack of long-term safety data on breast
implants. Breast implants have been sold for almost 40 years, and yet the
FDA has never required long-term safety data. They have not required that
patients be informed of the risks of implants. Meanwhile, more than
127,000 adverse reactions have been reported regarding silicone gel
implants and more than 65,000 for saline-filled implants - and yet the FDA
has not even bothered to examine them. As this Committee considers
legislation to reform the FDA in the coming year, I urge you to include a
provision requiring long-term
safety data for implanted medical devices that are already on the
market. This is not like a new medical product: women who have had
implants for many years are available to be studied, and the FDA should be
mandated to do so.

I would be glad to answer any questions, and I invite staff to go to our
website, http://www.center4policy.org, to read some of the medical and lay
articles that we have written on the topic, and to link to FDA's consumer
materials about breast implants.
Dr. Diana Zuckerman, Executive Director, National Center for Policy
Research for Women and Families, 1444 I Street, N.W., Suite 900,
Washington, DC, 20005

OFFERED WITHOUT COMMENT!!
Pittsburgh, 11/20/01 (PRNewswire): A new kind of silicone breast implant
will be used in a clinical trial beginning at Magee-Womens Hospital that
may signal a return to silicone gel implants. The study, which is being
undertaken by UPMC's division of plastic surgery, will focus on the CoheSIL
implant manufactured McGhan Medical Corp., a Santa Barbara, Calif.-based
company that makes both saline- and silicone- filled breast implants. "For
a great many American women, breast reconstruction provides a tremendous
psychological, physical and emotional uplift following breast cancer
surgery," said Kenneth C. Shestak, M.D., F.A.C.S., study principal
investigator and interim chairman of the division of plastic surgery at the
University of Pittsburgh School of Medicine. "And for many more, breast
augmentation may lead to a more fulfilling life through better confidence
and an improved self-image."

The study is designed to examine the safety and efficacy of the new
implant, which contains a silicone gel and has a more durable casing than
previous models. "Silicone has been considered by many plastic surgeons to
be a more desirable alternative to saline implants for breast augmentation
and reconstruction," said Dr. Shestak, who is an associate professor of
surgery. The CoheSIL implant is made of cohesive silicone gel and is
encased in a silicone shell that is designed to hold its shape better than
the saline implants currently in wide use, according to McGhan Medical
Corp., a leading supplier of breast implants. In addition, a textured
surface increases tissue adherence to stabilize the position of each implant.

Magee-Womens Hospital is seeking to enroll at least 10 women who are
considering breast reconstruction surgery and who will think about
receiving the CoheSIL implants. Women who enroll should not have undergone
previous implant surgery. Study participants will be followed at specific
time intervals over a 10-year period and undergo thorough examination to
determine the performance and durability of the implants.

In the late 1980s, safety concerns prompted litigation regarding silicone
breast implants, and eventually led to their withdrawal for use in routine
breast augmentation in the United States in 1992. However, links between
the implants and a variety of health problems have been disproved,
according to large collaborative studies of the medical literature in the
United States and the United Kingdom. The U.S. Food and Drug Administration
has designated the implants as Class III medical devices, subject to FDA
approval.

Dr. Shestak, a noted plastic surgeon who has done more than 1,000 implant
procedures during his 18-year career, said a review of virtually all
studies published in peer-reviewed medical journals supports the safety of
silicone implants. Current studies also find no connection between the use
of a silicone implant and any known disease in humans. The National
Academy of Sciences' Institute of Medicine (IOM) reported in 1999 that a
similar study review failed to find a basis for health concerns regarding
silicone implants. "In the evaluation of epidemiological data, the IOM
report indicated that immunological diseases, cancer, neurological and
other systems conditions did not appear to be increased in women with
breast implants when compared to women who did not have implants," Dr.
Shestak said.

A total of 940 patients will participate in the CoheSIL study at 47 centers
nationwide, with about half enrolled for augmentation and the remainder
scheduled for reconstruction or revision surgery. The Magee study is
restricted to breast reconstruction cases. Women who are considering such
breast surgery must be at least 18 years old and meet certain other
criteria to enroll in the CoheSIL trial. For more information on study
requirements or to enroll, call Shane Peters at Magee-Womens Hospital at
(412) 641-4828.

Contact: Michele D. Baum, BaumMD@msx.upmc.edu, or Alan Aldinger,
AldiAL@msx.upmc.edu, +1-412-647-3555, or Fax: +1-412-624-3184, both of UPMC.

FOREIGN ISSUES: EU Issues Guidelines for Safer Breast Implants: Brussels
(Reuters) - The European Commission presented new guidelines for safer
breast implants but stopped short of calling for a ban on silicone. In a
document approved on Thursday, the European Union's executive urged member
states to improve implant quality and make sure women were properly
informed of the risks before undergoing surgery. ``Patients should know the
advantages and the disadvantages of implants and be given all the relevant
information that allows them to make a well informed and thoroughly
considered decision,'' European Commissioner Erkki Liikanen said in a
statement. The Commission did not propose a ban on silicone implants, as
women's health groups have demanded. A recent European Parliament report
said there was no clear scientific link between silicone gel breast
implants and disease. Several studies to determine whether silicone
implants can be linked to cancer and other diseases have been inconclusive.
However, the parliamentary report said problems such as bleeding and
ruptures did occur. Implants are made from a variety of materials,
including silicone, salt water and soybean oil. The US Food and Drug
Administration banned silicone gel implants for most women in 1992 because
of safety concerns. In the 15-nation European Union, only France bans such
implants. The European Commission did not propose a minimum age requirement
for breast implants but said member states could consider recommending one.

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