FDA Takes Closer Look Into Implant Safety During Two Day Hearing

By: Courtney Floyd

Blogs

March 26th, 2019 concluded the US Food and Drug Administration’s two-day hearing reviewing the safety of breast implants.

The hearing included breast implant manufacturers, physicians and patients who have experienced health complications they believe are directly linked to their implants. Some of the described conditions included chronic fatigue, hair loss, joint pain and headaches—collectively known as “breast implant illness."  The most alarming complication mentioned was cancer.

Although there has not yet been any scientific evidence to prove implants are the cause of “breast implant illness,” there is evidence to support that textured implants can cause a rare form of cancer known as Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA-ALCL).

About 300,000 breast augmentations and 100,000 implant-based breast reconstructions occur in the U.S. each year, according to the American Society of Plastic Surgeons.  To date, over 660 women have been diagnosed with BIA-ALCL with a reported 12 deaths. 

Some of the patient testimonies during the hearing called for a complete ban of textured breast implants. However, the FDA did not recommend any immediate restrictions at this time, stating that more information would be needed to fully understand the causes of the implant related health problems.  In fact, later this summer, the US National Breast Implant Registry is expected to launch, providing a national database to collect real time data on patients diagnosed with BIA-ALCL to better understand this rare complication.

The FDA did however strike Mentor and Sientra (manufactures of breast implants) with warning letters last week for failing to fully meet post-market study requirements. Mentor cited falling rates of textured implant use as a challenge, while Sientra said they faced proper study issues due to women healthy and satisfied with their implants not participating in follow-up studies.

A common agreement throughout the hearing was the need for better education and surveillance of breast implant related health problems.  Patients consistently reported not being informed of the potential risks associated with breast implants or the potential need for additional surgeries down the road. Some patients testified they felt "blindsided" by their doctors and called for new legislation on informed consents.

In conclusion, textured implants are likely not going off the US market anytime soon, even though they have been pulled from the shelves in Europe.  We can be encouraged however in knowing that patient and physician advocates are making an impact and their voices are being heard.  With calls for more research and better patient education, we can have hope that there will be better understanding of implant's long-term impact on patient health and improved patient education. 

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