Skip to main content

FDA Declines to Ban Breast Implants

In recent years, it has become increasingly clear that breast implants aren’t safe and can lead to incredibly damaging consequences. Many women who have undergone breast augmentation or reconstruction surgeries have reported adverse health effects, leading to a condition called Breast Implant Illness (BII). Despite mounting evidence, the FDA has decided not to ban breast implants from the U.S. market.

A Contentious Decision By The FDA

In March 2019, the FDA held a two-day meeting of the General and Plastic Surgery Devices Panel to address the safety of breast implants. During this meeting, concerns were raised regarding the potential link between textured breast implants and BIA-ALCL, a rare cancer of the immune system. Testimonies from plastic surgeons and affected women shed light on the adverse health consequences experienced post-implantation.

Despite growing concerns and actions taken by other countries to ban implants, the FDA decided not to follow suit. The FDA acknowledged that textured breast implants are associated with BIA-ALCL, but it decided against banning any specific implant models from the market.

Breast Implant-Related Health Risks

BIA-ALCL is a cancer closely tied to textured breast implants. As of August 2023, the FDA has received a total of 1,358 US and global medical device reports (MDRs) of BIA-ALCL, resulting in a total of 59 deaths. While the FDA acknowledges the link between textured implants and BIA-ALCL, it considers the risk to be very low.

Beyond BIA-ALCL, there is a growing concern over BII. For decades, women with breast implants have reported a constellation of symptoms experienced after receiving breast implants. These symptoms include chronic fatigue, pain, cognitive issues, immune system problems, and more. However, women have consistently been led to believe that their symptoms were psychosomatic or caused by other unrelated issues.

The FDA holds that there isn’t definitive evidence proving that breast implants cause these symptoms. However, as evidence grows, the FDA has acknowledged that some women’s symptoms improve upon implant removal. In fact, Dr. Shaher Khan specializes in breast implant removals, and he has consistently found that women report overall improved health and quality of life once their implants are removed.

Informed Consent and Warning Labels

In response to these safety concerns, the FDA has included a black-box warning – its most severe form of caution – for breast implants. Additionally, doctors must discuss implant risks with patients using a checklist before surgery. These measures aim to ensure patients can access comprehensive information about the potential risks associated with breast implants.

However, Dr. Khan and many patient advocacy groups believe it’s simply not enough. While the FDA’s statement indicates progress in addressing breast implant safety concerns, the use of terms like “would” and “could” in its proposed actions leaves room for doubt. Furthermore, more needs to be done to make patients aware of the real risks of breast implants.

Dr. Shaher Khan strongly advocates for the recognition of Breast Implant Illness (BII). He refuses to perform breast implant surgeries on his patients and specializes in implant removals. If you are concerned about breast implants or suffering from symptoms that you can’t attribute to any specific condition, please schedule a consultation with Dr. Khan.

CONTACT 734.419.1615