Public Citizen Urges FDA to Require More Testing of Breast Implants Before Approval

By Griet Van Acker

A decades-long debate about the safety of breast implants culminated in an emotionally charged call for better regulation. During a two-day public forum before an advisory committee of the U.S. Food and Drug Administration (FDA) held in March, Public Citizen urged the FDA to stop treating women like guinea pigs.

Breast implants have caused many serious medical conditions in women, including scarring, pain and hardening of the breasts when the implants rupture and leak silicone gel. These implants have also caused hundreds of cases of an unusual type of cancer known as anaplastic large cell lymphoma and have been linked to autoimmune diseases. Hundreds of thousands of women in the United States get breast implants every year for cosmetic and reconstructive reasons.

Public Citizen has sounded an alarm for more than 20 years  about serious health problems linked to breast implants. In 1991, Public Citizen petitioned the FDA to ban silicone gel breast implants because of concerns about implant rupture, other local reactions, carcinogenicity and implants’ link to autoimmune diseases. The FDA removed silicone gel-filled breast implants used for cosmetic reasons from the market in 1992 but in 2006 allowed newly approved implants to be sold under the condition that manufacturers conduct post-approval studies to assess their long-term safety.

But that process was backwards, Public Citizen maintains.

“Trials to obtain information about the risks of breast implants should have been conducted before, not after approval. The long list of dangerous side effects from breast implants shows why much more extensive mandatory pre-approval testing on such permanently implanted devices is necessary,” said Dr. Sidney Wolfe, founder and senior adviser of Public Citizen’s Health Research Group, who testified before the panel.

The FDA panel urged the agency to take steps – including a standardized and easy-to-understand consent form – to ensure that patients have a better understanding of the risks associated with breast implants, but it stopped short at calling for a ban.

To read the complete May/June issue of Public Citizen News, click PC News MayJune.