FDA Proposes Black Box Warning for Breast Implants

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(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.”  

About Palm Beach Plastic and Cosmetic Surgery

Headed by Fredric M. Barr, MD, Palm Beach Plastic & Cosmetic Surgery is one of the finest providers of plastic and reconstructive surgery in Palm Beach County, Florida. With a successful track record for over thirty years in the area, Palm Beach Plastic & Cosmetic Surgery is the surgical specialist that even physicians choose. The practice believes in three basic patient principles of understanding the unique needs of each patient, providing each patient with the utmost care and compassion, and making sure no question or issue goes unaddressed. It is for those reasons, along with the extensive skills and experience of Dr. Barr, that Palm Beach Plastic & Cosmetic Surgery is a premier choice for those desiring to be renewed in both beauty and spirit. When it’s time to look anew, look to Palm Beach Plastic & Cosmetic Surgery. With offices conveniently located in West Palm Beach and Palm Beach Gardens, call today 561-833- 4122.

Palm Beach Plastic and Cosmetic Surgery

1411 N Flagler Dr
suite 5800
West Palm Beach, FLORIDA 33410
United States