FDA Proposes Black Box Warning for Breast Implants

(Newswire.net — November 19, 2019) West Palm Beach, FL — The U.S. Food and Drug Administration (FDA) is proposing manufacturers implement a “black-box warning” on breast implant packaging – a bold step to warn women about the potentially serious dangers of breast implants. 

The proposal was put forth on Oct 23, as a means of aggressively cautioning women and specifying what the risks of saline and silicone gel-filled breast implants could be. 

Many women have accused the FDA of not clearly laying out the potential risks of breast implantation surgery. Potential risks include chronic fatigue, joint pain and a rare form of cancer called breast-implant associated anaplastic large-cell lymphoma. 

According to the FDA, a black box warning “appears on a prescription drug’s label and is designed to call attention to serious or life-threatening risks.” It is the strictest warning, used when there is reasonable evidence of an association of a serious hazard with the drug or medical device. The warning has a black box around it, thus giving the warning its name.

To West Palm Beach Plastic Surgeon, Dr. Fredric Barr – a surgeon who has performed thousands of breast implants over his almost 30-year career – this step by the FDA is good news. 

A Board Certified Plastic Reconstructive Surgeon, Barr recently stopped performing breast implants due to growing concerns that breast implants could be harming women’s health. Barr states some women are reporting symptoms such as “diffuse hair loss, fogginess, skin changes, fatigue and thyroid issues – the list (of symptoms) goes on and on.” 

While the research around Breast Implant Illness is ongoing and hasn’t yet been able to clearly explain some of the health issues that women with breast implants are experiencing, plastic surgeons like Dr. Fredric Barr recognize the need for these patients to have a physician who is willing to listen to their concerns. He emphasizes the need for physicians to take their patient’s health complaints seriously and to address them as soon as possible: “If they tell me they feel their implants are causing them harm, my job is to remove those implants,” says Barr. 

In an effort to improve their health, some symptomatic women are electing to have their implants removed through a procedure called Breast Implant Explantation (En Bloc) when it is suspected their implants be making them sick. Likewise, other women who feel well are choosing to remove their implants for precautionary measures. 

Barr, who immediately posted a video on his website informing visitors of the FDA’s proposal, has seen how taking implants out has improved the health of many of his patients. “Taking implants out, seeing improvements – it’s been amazing.” He also states that this process has been an eye-opening experience for him as a practitioner: “To learn patients know their bodies, and we, as physicians, need to listen and help them.”