April 12, 2005 -- An FDA advisory panel on Tuesday narrowly rejected a bid to allow silicone breast implants back on the U.S. market after a 13-year partial ban. Panel members cited a lack of data about the long-term safety of the controversial implants.
The expert panel voted 5 to 4 to prevent sales of implants made by Inamed to U.S women for breast augmentation. The panel is due to vote tomorrow on a similar product made by Mentor.
Inamed was seeking to make silicone implants widely available for the first time since 1992, when they were pulled from the vast majority of the U.S. market because of questions about the health impact of leakage from ruptured implants.
Tuesday's vote was the second time in 18 months that FDA advisors passed judgment on the company's implants. The agency withheld clearance even after another panel backed approval of the implants in October 2003, instead telling the company to collect more safety information.
Use of silicone implants -- on the U.S. market for most of the last 30 years -- was strongly backed by cosmetic surgeons who maintained that they are superior to widely used saline implants for women seeking breast augmentation or reconstruction after mastectomies.
Thousands of women have blamed leaking silicone implants for a variety of health problems, including autoimmune diseases, connective tissue disorders, and cancers.
A 1999 Institute of Medicine study declared no connection between the implants and systemic diseases, though that same year former implant maker Dow Corning agreed to pay $3.2 billion to settle claims that its products sickened patients.
Experts on Tuesday praised Inamed officials for a detailed study showing that less than 5% of women with the implants experienced ruptures within three years of surgery. Inamed officials said that they could not link any of the ruptures in their study to serious health effects and instead only found an increased likelihood of local symptoms like pain and breast hardness around broken implants.
"Our data has shown no systemic illness, no connective tissue diseases over and above what you would expect in the general population," said Patricia Walker, MD, the company's executive vice president for research and development.
The company was trying to market a newer implant filled with thicker silicone that officials said was less liquid than in previous models and therefore less likely to leak.
But a majority of experts said it was troubled that the company had no information on the implants' durability beyond four years, raising questions about how many could break after extended use.
Company officials had estimated that 14% of the implants would rupture within 10 years of surgery. FDA scientists had attacked that assertion, saying that it was based on an assumption that the devices would fail at a constant rate each year.