After hundreds of women reported developing a rare form of blood cancer, the FDA wants manufacturers to issue the strongest kind of warning to remind doctors and patients of risks of breast implants
The US Food and Drug Administration wants manufacturers of breast implants to issue a “box warning” on labeling material for breast implants, much like the warnings on cigarette boxes. It’s the most serious type of warning required by the government administration. The purpose of the warning will be to remind doctors as well as their patients just how risky breast implants can be, as the FDA maintains that most women are not “fully informed of the risks” before getting the surgery. It would be the doctor’s responsibility to relay the warnings to the patient, as patients obviously don’t examine a box of implants prior to surgery.
As of July 6, 2019, 573 people have reported developing a rare type of blood cancer, anaplastic large cell lymphoma or BIA-ALCL, and 33 people have died. Other risks can include rupture, scarring, and pain. Additionally, many women don’t realize that breast implants are not intended to be permanent, and need to be removed or changed out every eight to ten years.
The US Food and Drug Administration has released draft guidance recommending a "boxed warning" on labeling materials for breast implants. Boxed warnings are the strongest form of warning required by the FDA for labeling. https://t.co/xwL5mpfHWt
— CNN (@CNN) October 23, 2019
According to CNN, the boxed warnings would says things like “breast implants are not considered lifetime devices” and “breast implants have been associated with the development of a cancer of the immune system called breast implant-associated anaplastic large cell lymphoma.” They are also proposing that patients considering breast implants review a “decision checklist” with their physician, basically outlining risks and offering other options and recommendations.
Women should be warned of breast implants’ risks, including fatigue, joint pain and the possibility of a rare type of cancer, the FDA said https://t.co/xQrM7e5hM5
— The New York Times (@nytimes) October 23, 2019
The boxed warnings are currently in “draft guidance”, which means that they are up for public commentary and review. “The draft guidance offers numerous recommendations to help ensure women have access to this information, including that manufacturers incorporate a boxed warning and patient decision checklist in the device’s labeling, update recommendations for patient screening for device rupture and more,” FDA Principal Deputy Commissioner Dr. Amy Abernethy and Dr. Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health explained in a statement.
“Taken as a whole we believe this draft guidance, when final, will result in better labeling for breast implants that will ultimately help patients better understand breast implant benefits and risks, which is a critical piece in making health care decisions that fit patients’ needs and lifestyle,” the statement continued. “After a period of public comment, once the guidance is finalized, manufacturers may choose to follow the recommendations in the final guidance or they may choose other methods of labeling their devices, so long as the labeling complies with applicable FDA laws and regulations.”
Breast augmentation is the most popular cosmetic surgery in the country, according to the American Society of Plastic Surgeons. For some, the procedure is purely cosmetic, and for others, especially those who undergo a double mastectomy as a result of breast cancer, it is restorative. While most women don’t experience complications, a surprising number do. According to the FDA, as many as 20 percent of people with implants are forced to have them removed prior to the recommended eight to ten years because of complications.
No matter what type of surgery you are considering, elective or not, let this latest announcement from the FDA serve as a reminder to always do your research. While it should be your physician’s responsibility to educate you about all the potential risks and complications about any procedure, ultimately it is your health on the line.