Delay Urged on Decision on Implants
Displaying ruptured implants and gruesome photographs, health and consumer groups Monday called on the government to delay a decision on whether to allow silicone gel breast implants back on the market.
The Food and Drug Administration, which banned the marketing of silicone implants for cosmetic surgery in 1992, could rule later this year on an application from the Santa Barbara-based Inamed Corp.
Although the decision of FDA reviewers will be based largely on two years of clinical trials, the health groups say many implant ruptures and other associated health problems often do not develop until at least seven years after surgery.
The FDA “has a responsibility to assure women ... that what they put in their bodies is safe,” said Kim Gandy, president of the National Organization for Women. She characterized the agency’s current review plan as “grossly inadequate.”
Susan Wood, director of the FDA’s Office of Women’s Health, defended the agency’s decision to consider two years of pre-market research and up to eight years of post-market study. “We do believe that the data [we have] will allow us to make a decision,” Wood said.
The groups’ dramatic news conference publicly opened a new round in a controversial area of women’s health, one in which science has often clashed with public demand.
Researchers estimate that 1 million to 2 million women have received silicone implants since the 1960s.
And despite questions about the safety of silicone and saline breast implants, breast-enlargement surgery has continued to grow in popularity. Almost 250,000 breast augmentation procedures were performed last year, a 147% increase from 1997, according to the American Society for Aesthetic Plastic Surgery. Patients undergoing reconstructive surgery after breast cancer had an additional 70,000 operations.
The FDA had no authority to regulate breast implants until 1976, and it did not require manufacturers of silicone implants to submit safety studies until 1991, one year before it banned them.
The agency conducted its first safety review of saline-filled implants in 2000, and the results reflected its attempts to juggle the competing demands of manufacturers, surgeons, lawyers, consumer advocates, women who wanted implants and those whose implants had caused health problems.
At the time, it ruled that two Santa Barbara firms, the McGhan Medical Corp. and the Mentor Corp., could continue to market saline implants “despite relatively high complications and failure rates.” The FDA said information on the risks should be made available.
Dr. Sidney Wolfe, director of Public Citizen’s Health Research Group, charged Monday that the FDA never fully implemented the 1976 law, which required the agency to certify the safety of medical devices before they were put on the market.
Wolfe also accused the agency of using a “double standard” in regulating breast implants. “It took long-term information to get [silicone implants] off the market, and now short-term information is being used to bring them back,” he said.
Inamed completed the application process for a new silicone implant in December. It submitted data from a clinical trial involving about 1,000 patients who had been followed for at least two years, Peter Nicholson, an Inamed vice president, said Monday.
The company, with $300 million a year in U.S. and international sales, manufactures saline and silicone implants. But based on re-approval of silicone implants in France in 2000, Inamed officials believed that the U.S. market would shift sharply from saline if silicone implants were allowed back on the market, Nicholson said.
Silicone implants provide a more natural breast shape and tend to hold the shape better, manufacturers, surgeons and health advocates agree. But silicone implants also harden and “end up like a rock,” said Paul H. Wooley, a professor at the Wayne State University School of Medicine in Detroit.
Various scientific studies, including some funded by the government, have disagreed on whether the seepage of silicone into surrounding tissues and the lymphatic system can cause rheumatoid arthritis, lupus and other autoimmune diseases.
“We simply don’t know down the line what is going to happen,” said Wooley.
However, many studies have documented a “failure rate” of silicone implants. They indicate that 10% to 17% of silicone implants rupture within five years of surgery and that 70% rupture within 17 years.
Dr. Edward Melmed, a plastic surgeon in Dallas who implanted thousands of silicone sacs before 1992 and now removes them, said they “ooze oil from the word go.” Melmed displayed four silicone implants that he removed last week. Only one was intact. “Plastic surgeons are pushing this product as if nothing’s going to happen,” he said. Yet “the average number of surgeries [he sees per woman] is four.”
Asked what failure rate was too high, Inamed’s Nicholson said, “That’s what the FDA is going to tell us....We feel that there is a growing body of scientific evidence that supports silicone-based implants.”
Nicholson predicted that an FDA advisory committee could hold a public hearing on the company’s applications as soon as October -- or it could form a special advisory panel that would meet before then.
Wood said the FDA had set no timetable.
