Silicone-gel breast implant complications to be watched out for: FDA

By Dr. Ananya Mandal, MDJun 23 2011

The U.S. Food and Drug Administration (FDA) said Wednesday that women receiving silicone-gel breast implants have frequent complications like scarring or hardening breasts, and 20% or more of patients required implant removal within 10 years.

They however said their reports did not show any unexpected or new safety concerns, and the implants will stay on the market. The conclusions were drawn in large part from studies done by the implants' manufacturers, Allergan Inc. and Johnson & Johnson's Mentor Worldwide unit. Silicone breast implants were allowed back onto the U.S. market for cosmetic purposes in 2006, after their sale was sharply curtailed by the FDA in 1992 over perceived safety issues.

FDA said in its analysis of medical data, “Despite frequent local complications and adverse outcomes, the benefits and risks of breast implants are sufficiently well understood for women to make well informed decisions about their use.” Jeffrey E. Shuren, director of the FDA's device division said it is imperative for women with implants to get routine medical images to screen for implant ruptures and other complications. Women should notify doctors if they experience pain, swelling or other changes, he said. “The longer the woman has the silicone implant, the more likely she is to have experienced complications,” said Shuren.

Allergan and Mentor spokespersons said in a statement that silicone gel-filled breast implants are safe and effective when used as intended. “We concur with FDA that women should fully understand there are potential risks associated with breast implants, and they should discuss risks and benefits with their plastic surgeon prior to breast augmentation or reconstruction,” Mentor said in a statement.

According to the data released Wednesday, 20% to 40% of women receiving implants for augmentation had a reoperation in the first eight to 10 years after getting the implants. The figure was 40% to 70% for women who got implants for reconstruction, including after cancer surgery.
Experts said 5 million to 10 million women worldwide have breast implants. The FDA said one of the most common side effects was a hardening of the breast around the implant. Other side effects include rupture and gradual seeping out of silicone as well as scarring, pain and infection. In January, the agency warned there may be a small but increased risk of a rare type of cancer in women with silicone- or saline-filled implants. It didn't release any new information on that risk Wednesday. Shuren said there are 34 cases in published literature and, at most, 60 cases worldwide, of the rare lymphoma among the millions of women with implants.

A preliminary analysis of data being collected by two companies that won approval for silicone gel-filled implants in 2006 and other data found no evidence that the implants cause breast cancer, reproductive problems, rheumatoid arthritis or other major health problems, the Food and Drug Administration said.

Diana Zuckerman of the National Research Center for Women and Families, a Washington-based consumer group, noted that many of the women in the studies ended up dropping out, raising questions about the usefulness of the findings. “The studies don’t provide most of the safety information that they were required to provide,” Zuckerman said.