Newsflash on the FDA silicone review.
FDA Advisory Panel Recommends
Conditional Approval of Mentor Silicone Gel-Filled Breast
Implants; Patient Advocates Hail Decision as Victory for
Women Considering Breast Augmentation or Reconstruction
SANTA BARBARA, Calif.--(BUSINESS WIRE)--April 13,
2005--Mentor Corporation, a leading supplier of
medical products in the United States and internationally,
today announced that an advisory panel to the U.S. Food
and Drug Administration (FDA) determined that the
Company's silicone gel-filled breast implants are safe and
effective for use in breast reconstruction and
augmentation patients. The 7-2 recommendation for
approval, with a series of conditions stipulated by the
FDA's General and Plastic Surgery Advisory Panel,
represents a significant step towards full approval of
Mentor's silicone gel-filled breast implants in the United
States.
"This is a major victory for women who are considering
the personal choice of breast implants," said Betsy
Mullen, a patient advocate and founder, President & CEO of
WIN Against Breast Cancer. "The panel clearly recognized
what we've known for years. Silicone implants are a safe
and important option for women who prefer the realistic
feel and better appearance that these products offer."
The vote of the Advisory Panel was based primarily upon
its review of Mentor's pre-market approval (PMA)
application filed in December 2003 and on the company's
PMA amendment filed in August 2004. This vote followed
yesterday's Advisory Panel vote recommending against
approval of Inamed Corporation's silicone gel-filled
breast implant application. If the FDA follows both
recommendations of its Advisory Panel, Mentor's Memory Gel
TM) products would likely be the only approved silicone
gel-filled breast implants in the U.S.
Presently in the United States, silicone gel-filled
breast implants are only available for women who are
eligible and elect to participate in an FDA-approved
continued access study for breast reconstruction and
revision patients.
"This is good news for Mentor, and great news for
doctors and patients," said Joshua H. Levine, President
and Chief Executive Officer of Mentor Corporation. "If
ultimately approved by the FDA, Mentor's Memory Gel TM)
breast implants will be a significant addition to the
options for women seeking breast augmentation or
reconstruction in the United States. The panel deserves a
lot of credit for thoroughly examining the scientific data
before reaching the same conclusion we have reached--that
Mentor's silicone gel-filled breast implants are a safe
and effective option for women."
Mentor is focused on providing smart and effective
solutions for surgeons and the patients they serve. All of
Mentor's silicone gel-filled breast implant products are
filled with Memory Gel TM), a proprietary silicone gel
formulation that holds its shape but remains soft,
resulting in a more realistic appearance. By varying the
ratio of the components of the gel, Mentor is able to
provide a wide selection of products that address the full
range of customers' needs. More than 1,000,000 women in
over 50 countries have received Memory Gel(TM) implants.
While Mentor currently markets saline-filled breast
implants, its Memory Gel(TM) silicone gel-filled products
provide an option for patients seeking a more realistic
feel and appearance. "Mentor's gelatin-like, cohesive
breast implants are designed to mimic the soft tissues of
the human body," said Levine. "While the personal needs of
each patient vary, experienced physicians are able to use
Memory Gel(TM) products to provide both breast
augmentation and reconstruction surgery patients a
realistic breast contour."
"Most of my patients do significant research about
breast implants, and then work closely with me and my
staff to make an informed decision that meets their needs.
These are patients who want to know that all of the safe
options are made available to them," commented Dr. Scot
Glasberg, a New York City plastic surgeon. "As a doctor, I
look forward to the possibility of being able to provide
Mentor's Memory Gel(TM) products as one of those options."
