New silicone breast implants appear to be safe, FDA says

Rob Stein

The Washington Post | June 22, 2011

Two recently approved silicone gel-filled breast implants appear to be safe for most women according to preliminary data, the Food and Drug Administration said Wednesday.

The early data from the two companies’ studies on the safety of the implants found no evidence that they cause any significant health problems, the FDA said in a statement released in advance of a news briefing for reporters. The agency required the companies to perform the studies as a condition for the devices’ approval.

“Based on the totality of the evidence, the FDA believes that silicone gel-filled breast implants have reasonable assurance of safety and effectiveness when used as labeled,” the agency said in a summary of the data.

The safety of silicone breast implants has long been questioned. The implants were banned for most U.S. women in 1992 after there were concerns that they may be linked to a variety of health problems, including cancer and rheumatoid arthritis. But after subsequent studies appeared to exonerate the implants, the FDA allowed sales to resume in 2006, despite protest from some consumer advocates.

In January, the FDA warned that implants might increase the risk of developing a rare form of lymphoma known as anaplastic large cell lymphoma (ALCL), a cancer of the immune system.

In the report on the two new devices, the FDA said an update of the scientific evidence available on the implants confirms that silicone gel-filled breast implants are safe and effective when used as intended.” A possibility of a small increased risk for ALCL remains, however.

In addition, the agency cautioned that women should fully understand the risks before considering silicone gel-filled breast implants for breast augmentation or reconstruction.

“Breast implants are not lifetime devices. The longer a woman has silicone gel-filled breast implants, the more likely she is to experience complications,” the FDA said, noting that one in five patients who received implants needs to get them removed within 10 years.

Among the the most common complications are “capsular contracture,” a painful hardening of the area around the implant, the FDA said. The devices can also rupture, wrinkle, shift out of position and cause scarring, pain and infections, the agency said.

However, preliminary data do not indicate that the implants cause breast cancer, reproductive problems or diseases such as rheumatoid arthritis, but larger, longer studies would be needed to know for sure, the FDA said.

The report includes preliminary safety data from studies conducted by Allergan Inc. and Johnson & Johnson’s Mentor Corp.

“The FDA will continue to monitor and collect safety and performance information on silicone gel-filled breast implants, but it is important that women with breast implants see their health care providers if they experience any symptoms,” said Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health. “Women who have enrolled in studies should continue to participate so that we may better understand the long-term performance of these implants and identify any potential problems.”

Diana Zuckerman of the National Research Center for Women & 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 the safety information that they were required to provide,” Zuckerman said in an e-mail. “The studies show many women with implants have complications, but so many of the women dropped out before the research was completed that it is impossible to say what percentage of women need additional surgery or have health problems five or 10 years after getting breast implants.”

The FDA acknowledged the problems with the studies and said the agency was convening a panel of outside experts in the next few months to discuss how additional studies can be more effective.