Statement of Diana Zuckerman, PhD on FDA Approval of Breast Implants

Diana Zuckerman, PhD, National Center for Health Research, September 21, 2005

Today the Food and Drug Administration (FDA) issued an “approvable letter” to Inamed Corporation for their silicone gel breast implants. Inamed Corp. was granted this first step in the approval process based on a revised application that is missing most of its breast cancer patients. After their application was rejected by the FDA a few months ago, Inamed belatedly decided to eliminate a defective style of breast implant (Style 153) from their application for approval. Unfortunately, two-thirds of the breast cancer patients in their study had this defective style of implant, which had a tendency to break even during the first three years in the body. When the company resubmitted their application, they removed those women from their study, apparently leaving fewer than 30 breast cancer patients who underwent MRIs to determine if their implants had ruptured or were leaking silicone. Yet the agency had asked that at least 250 breast cancer survivors be studied. In August, the Mentor Corporation also received an approvable letter.


“It is absolutely unacceptable to approve a breast implant that hasn’t been carefully studied to make sure it is safe for breast cancer patients. Sadly, this isn’t the first time — rival implant maker Mentor’s long-term data included zero breast cancer patients.

“The approvable letter was sent despite FDA scientists’ scathing criticisms of the company’s data and a vote from FDA’s advisory panel recommending that the implants not be approved. This action by the FDA once again raises questions about whether the agency is making decisions based on scientific evidence.

“This sounds familiar. Just a few weeks ago, the FDA ignored their own scientists when they refused to approve the morning-after pill for over-the-counter sales. Once again, the FDA is ignoring the concerns of their own scientists, this time potentially endangering breast cancer survivors.

“Only scientific evidence and solid safety data can protect women. Wishful thinking should not be a basis for approval.”