FDA to hear new data about silicone breast implants
Monday, December 6th 2004, 1:30 pm
By: News On 6
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 reanalyzing 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.