FDA Taking a Closer Look at Breast Implant Safety

Consumer advocates have long been opposed breast augmentation surgery for the simple fact that it offers no medical benefit and puts the patient at risk of serious and even life-threatening complications. The FDA admits that almost all breast implants will have to be removed at some point during a recipient’s life, with nearly half needing to be removed within the first 10 years. But despite this knowledge the agency’s stand on breast implants remains to be that the products are “safe and effective.” See the USA Today story here, and the BNet story here.

A campaign to ban breast implants, led by the National Women’s Health Network, the National Organization for Women, and the National Physicians Alliance, took center stage earlier this week as an FDA Advisory Committee listened to the concerns from advocates during a 2-day panel meeting.

The biggest complaint voiced by advocates is that the FDA relied on faulty data to come to their “safe and effective” viewpoint. Advocates claim that although the nation’s two largest breast implant manufacturers, Johnson & Johnson’s Mentor unit and Allergan, were required by the FDA to monitor the health of some 40,000 of the 400,000 women who undergo breast augmentation surgery each year, the companies somehow managed to lose track of 31% and 79% of their patients respectively, leaving them with too little data to properly measure risks.

Advocates told the panel that the implants should be banned unless drastic improvements are made in the participation of the post implant studies conducted by Mentor and Allergan.

Without proper post implant monitoring it is impossible to properly evaluate the safety of these products.

The FDA said it wants to find ways to improve post-approval safety studies and to identify new approaches to mandated studies and surveillance of silicone implants that are likely to yield valuable information on their safety and performance.