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FDA to hear silicone breast implant data

http://www.firstcoastnews.com/health/news-article.aspx?storyid=28907

WASHINGTON (AP) -- Makers of silicone breast implants will try to
persuade the government next spring to lift a long-term ban on most
uses of the devices, presenting new data about safety and durability.

Inamed Corp., a California company whose gel implant was rejected last
January by the Food and Drug Administration, said it had been notified
that an advisory panel would review new information submitted by the
company at a meeting in April.

Nick Teti, president of Inamed, said in a statement that the firm also
has submitted an approval application to the FDA for a new, improved
gel breast implant which the company already is selling in Europe.

The FDA disapproved the Inamed application in January and set new
guidelines for the scientific questions that must be answered before
the silicone breast implants can be used for figure augmentation. The
implants are approved for women seeking reconstruction after breast
cancer surgery.

Silicone breast implants were sold routinely in the United States for
some 20 years, but starting in the 1980s many patients complained that
the devices broke, allowing the silicone to spill into their bodies.
Many blamed illnesses on the silicone and thousands sued the implant
manufacturers. A major settlement, involving billions of dollars and
thousands of lawsuits, was approved in 1999.

The FDA in 1992 banned use of the silicone implants for all but breast
reconstruction.

A study by the Institute of Medicine in 1999 said there was no evidence
that implants cause major illnesses, such as breast cancer or lupus.
The study, however, said that complications, such as breakage and
scarring, are frequent.

Dan Cohen, an Inamed vice president, said Inamed will present the
advisory panel new studies re****yzing the causes of breast implant
breakage and reporting on the results of new mechanical testing on the
devices.

"Our goal is to get these devices back on the market," he said.

Cohen said that studies by the company show that among women receiving
the breast implants for augmentation only - as opposed to cancer
reconstruction - about 26 percent required new or additional surgery
and that 7.5 percent had the implant removed. He said that only about
1.2 percent of the implants actually ruptured while in place, however.

Mentor Corp., another silicone breast implant maker, is also expected
to provide testimony at the April meeting.

Sybil Goldrich, a claimant in the 1999 settlement against implant
makers, said she worried that the FDA will approve the sale of silicone
implants even without adequate safety data.

"This product has been on the market for more than 40 years and they
are still not able to prove that it is safe," said Goldrich. "I believe
in implants, but I want to see implants that actually work."

Goldrich, a cancer survivor, went through four sets of broken implants
in the 1980s, and filed formal complaints to the FDA starting about 15
years ago. She also participated in the multi-billion-dollar breast
implant settlement.