The FDA and Breast Implant Illness

While I was falling down the rabbit hole of BII, there were already steps being taken by doctors, independent researchers, and patients to confront and, hopefully, convince the FDA that breast implants cause cancer and cause breast implant illness.

On March 25, 2019, many brave women spoke at the FDA hearings to call for increased warnings and a total ban on specific types of implants that cause Breast Implant Associated—anaplastic large cell lymphoma (BIA-ALCL), a cancer of the immune system. They told their stories of never being given safety pamphlets, of never being told that the implants should be replaced every ten years, of debilitating illnesses that came after receiving implants, and the miraculous healing that came after explanting.

The type of implant most associated with anaplastic large cell lymphoma are textured implants, meaning that the outer silicone shell is made with a rough texture. However, there are known cases of women with smooth-surface implants developing BIA-ALCL, and many reports do not include the texture of the implants when diagnosed.

To be clear, you do not have to have silicone implants to have problems. Saline implants have a silicone shell. We were always led to believe (and are still being told today) that silicone is inert, but that idea was disputed by Dr. Jan Willem Cohen Tervaert, from the University of Alberta. He said silicone affects the immune system and can set off a series of reactions that can lead to the pain and fatigue.

During these hearings, some of the panel at least voiced their frustration at the lack of data on implants and the failure of breast implant manufacturers to complete promised studies or follow patients for long enough to collect meaningful data. They felt that the FDA fail women with regard to breast implants. I think most people would be completely shocked at how little it actually took for breast implants to become approved devices.

But will these hearings result in a ban on textured implants, as many other countries have already done? Will the FDA acknowledge BII so that the medical community can be made more aware and begin to help us?

To read more on the hearings, you can go here:

Reports of Breast Implant Illness Prompt Federal Review

Women at Breast Implant Hearing Call for Disclosure of Safety Risks