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Silicone Implant Lawsuit - (SafetyAlerts) 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.
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