FDA Panel Rejects Silicone Implants

Experts Concerned About Lack of Data on Long-Term Safety

From the WebMD Archives

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.

"It is difficult to predict the probability of rupture by year 10 with available data," Pablo Bonangelino, PhD, an FDA statistician told the panel.

"I feel a pressing urgency on us to approve this device at this time and I don't know why. I don't feel secure about the safety," said Amy E. Newburger, MD, a panel member and dermatologist from Scarsdale, N.Y.

Other experts -- primarily the panel's several plastic surgeons -- said they were confident that relatively few of the implants would fail after three years.

Inamed officials had promised to continue an ongoing study of silicone implants, and to launch a program educating surgeons on the proper handling and follow-up for the products.

Company data also showed that women experienced no symptoms in 86% of cases of rupture, leading several experts to question how physicians would be able to screen patients for leaking implants.

The company's application was strongly backed by plastic surgeons, who performed more than 300,000 breast implant procedures in 2004. "They feel more like breast tissue in their consistency. They ripple less and therefore feel more natural. Patients deserve to have a choice," one surgeon told the panel.

The application was equally opposed by dozens of women's groups and individual patients, who said that companies including Inamed have never shown t that silicone was safe to reside in the body for years.

Venessa Rose Presuto told panelists that she developed heart problems, skin sores, and hair loss after receiving silicone implants as part of an Inamed clinical trial several years ago. Leaking silicone led doctors to remove her breast tissue, she said.


"I was a healthy 26-year-old before I got silicone implants," she said.

Inamed vice president Dan Cohen said in an interview that the company was "disappointed" with the panel's vote but that it would continue to work to gain FDA's final approval of the implants.

"We believe in our data, we think the data is strong, and we disagree with the panel's recommendation," he said.

WebMD Health News


SOURCES: Patricia Walker, MD, executive vice president for research and development, Inamed. Pablo Bonangelino, PhD, safety reviewer, FDA. Amy E. Newburger, MD, dermatologist, Scarsdale, N.Y, member, FDA advisory panel. Venessa Rose Presuto. Dan Cohen, Inamed vice president for global government and corporate affairs.
© 2005 WebMD, Inc. All rights reserved.


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