FDA Wants Women To Receive Stronger Warnings About Risks Associated With Breast Implants
The FDA proposed on Wednesday that manufacturers detail possible complications from the devices, including rare cancers, a range of other symptoms and the need for additional surgeries. The move is a response to complaints from patients who said they weren’t adequately told about potential problems before surgery.
The New York Times:
Women Should Be Warned Of Breast Implant Hazards, F.D.A. Says
Women considering surgery to receive breast implants should be warned in advance of the risk of serious complications, including fatigue, joint pain and the possibility of a rare type of cancer, the Food and Drug Administration said on Wednesday. Agency officials are urging manufacturers to print a boxed warning on the packaging of the implants, and to provide a checklist spelling out the risks for prospective patients to review before making a decision and putting down a deposit on the surgery. It will be left to doctors to review those risks with women seeking breast implants. (Rabin, 10/23)
The Associated Press:
FDA Wants Stronger Warning On Breast Implants About Risks
The agency is also recommending patients complete a checklist to make sure they understand all the possible side effects of the implants, such as scarring, pain, rupture and even a rare form of cancer. "We have heard from many women that they are not fully informed of the risks when considering breast implants," the agency said in a statement detailing the recommendations. (Perrone, 10/23)
The Washington Post:
FDA Recommends New Warning For Breast Implants
The FDA’s steps are the latest effort to deal with reports of complications involving devices that have been at the center of sometimes angry debate and legal actions for decades. The devices are used in about 400,000 surgeries in the United States every year, with 75 percent of the women involved getting implants for cosmetic reasons. Most of the rest get them as part of reconstruction after surgery for breast cancer. Over the past few years, patients who say they were harmed by the devices have become increasingly active on social media sites that have enabled tens of thousands of patients to exchange information. (McGinley, 10/23)
In other news on women's health —
Kaiser Health News:
A Million-Dollar Marketing Juggernaut Pushes 3D Mammograms
When Dr. Worta McCaskill-Stevens made an appointment for a mammogram last year, she expected a simple breast cancer screening ― not a heavy-handed sales pitch. A receptionist asked if she wanted a free upgrade to a “3D mammogram,” or tomosynthesis. “She said there’s a new approach and it’s much better, and it finds all cancer,” said McCaskill-Stevens, who declined the offer. (Szabo, 10/22)
