| Ilena Rose 2005-07-28, 10:54 pm |
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FOR IMMEDIATE RELEASE: Contact:
Howard Gantman
Thursday, July 28, 2005
http://feinstein.senate.gov/
Women Senators Urge FDA to Consider Women’s
Health Safety in Decision on Silicone Breast Implants
Washington, DC – U.S. Senators Dianne Feinstein (D-Calif.) and Olympia
Snowe (R-Maine) along with seven other women Senators today urged the
FDA to carefully consider the safety of American women and the
recommendations of FDA’s own scientists prior to making a final
decision on approval of silicone gel breast implants. They wrote to
express concerns about the recent split decision by the General and
Plastic Surgery Devices Panel of the Food and Drug Administration
(FDA) on the applications of silicone gel implant manufacturers Inamed
and Mentor Corporations.
In 1992, FDA restricted the use of silicone implants amid widespread
claims that ruptured implants were causing health problems in women.
Since the moratorium was put in place, silicone breast implants have
remained available to women who have needed reconstructive surgery.
Later this month, the FDA is expected to rule whether the silicone gel
implants made by Mentor and Inamed are safe and should be available to
women for both breast reconstruction and augmentation. In April, an
FDA advisory panel recommended in favor of Mentor’s application but
not that of Inamed.
Following is the text of a letter Senators Feinstein, Snowe, Hillary
Clinton (D-N.Y.), Kay Bailey Hutchison (R-Texas), Barbara Boxer
(D-Calif.), Mary Landrieu (D-La.), Debbie Stabenow (D-Mich.), Blanche
Lincoln (D-Ark.), and Barbara Mikulski (D-Md.) sent to FDA
Commissioner Lester Crawford:
“We are writing to express our concerns regarding the recent split
decision by the FDA’s General and Plastic Surgery Devices Panel on the
applications of the Inamed and Mentor Corporations for approval of
silicone breast implants. The divergent recommendations of the Panel
on these two manufacturer’s devices appear inconsistent with the very
similar findings as described in the Summary Panel Memoranda for these
applications.
Reconstruction with implants or autologous tissue procedures can offer
significant benefit to women who have undergone a mastectomy. Over
215,000 women will be diagnosed with invasive breast cancer this year,
and for many, treatment will include a mastectomy. For such women,
the benefits of reconstruction can be substantial. We note that both
saline and silicone implants have been available to such patients, and
encourage FDA to continue to examine promising new prosthetics for
breast cancer patients.
The use of breast implants is not without hazards. Surgical risk must
be considered, and each woman must understand that these devices,
whether saline or silicone, have a finite life. In 2000, a study by
FDA scientists reported a failure rate of 55% per implant in women who
had silicone implants for an average of 16 years. Thus women
receiving implants, particularly at a young age, may anticipate
multiple surgeries with added financial burdens.
Silicone implants, while providing a prosthetic with more natural
characteristics, bear greater risks than saline implants. As the FDA
has noted, such implants can interfere with mammography. In addition,
when failure occurs and an implant ruptures, this usually occurs
without symptoms and is detected only via magnetic resonance imaging
(MRI) - and even MRI does not detect some ruptures.
FDA noted three critical problems in its 2005 review of the Inamed
application: long term failure rates for the device couldn’t be
accurately projected due to a short duration of study, the reasons
implants failed were not determined, and the impact of silicone
leakage on a woman’s health was unclear. In its most recent
application, Inamed included data indicating that symptoms of
connective tissue disease were evident as well.
The same basic issues remain unresolved for Mentor’s device. Mentor
Corporation provided short term failure rates which were encouraging,
but this conclusion was based on an unpublished study conducted on a
very select group of patients, all of whom were operated on by a
single surgeon. FDA noted many other problems with Mentor’s data,
including a failure to study women over time and the exclusion of
women who had implants removed – which could include additional
implant failures. As a result of these limitations, FDA does not know
the true failure rate for Mentor’s device, nor the implications of
implant rupture. The FDA memorandum also cited specific signs and
symptoms of connective tissue disease in augmentation patients with
the implanted Mentor device. We are thus extremely concerned that the
risks of this device are far disproportionate to the benefit that a
woman undergoing breast augmentation would realize.
For both Inamed and Mentor’s devices, the inability to project long
term failure rates and the causes of failures is a major concern.
Given that there are typically no symptoms when silicone breast
implants rupture, the cost in morbidity and expense to a woman may be
very substantial, as prudent medical practice could entail routine MRI
to detect ruptures, in addition to periodic surgeries to adjust or
replace implants.
We urge you to note the distinction between the use of implants for
reconstruction and augmentation. The FDA has stated, ‘the literature
does not provide strong scientific support that breast implants have
measurable psychological and psychosocial benefits for women seeking
breast augmentation.’ Such a conclusion of questionable efficacy
calls for the highest level of safety in approval of implants for
augmentation. It is our understanding that if not approved, silicone
breast implants will remain available for breast cancer patients as
they have been since 1992, reflecting the greater benefits for that
population.
Though some have argued that the imposition of post-marketing
conditions would address safety concerns, such conditions have proven
to be ineffective or unenforceable and thus cannot serve as a
substitute for long-term clinical data. Consequently we urge your
careful review of the Panel’s memorandum and consistent application of
the highest standards of safety in evaluating these applications, in
order to protect the health and well being of American women.”
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