WASHINGTON, -- U.S. regulators have issued stronger warnings about breast implants. They also added a requirement that women receive information about the potential risks and complications of these implants before they are placed.
The Food and Drug Administration has announced new regulations that are primarily targeted at implant manufacturers. They will also be required to include a boxed warning message -- which is the most serious type -- in their written patient materials.
FDA regulations are the latest in a long-running effort to address safety concerns with these devices. They are used primarily for breast augmentation. This is the most common cosmetic surgery procedure in the U.S. Each year, approximately 400,000 people have implants. 100,000 of these are after having cancer surgery.
Although the FDA originally proposed these rules in 2019 as voluntary measures, Wednesday's action makes them legal for all breast implant manufacturers, including top-tier brands like Johnson & Johnson's Mentor and Allergan.
Plastic surgeons and other healthcare professionals who deal with implants must provide their patients with a checklist listing possible side effects such as pain, scarring, rupture, and rare forms of cancer. This checklist also clarifies that breast implants are not considered permanent and may need to be repeated.
The document must be signed by the doctors and the recipients must confirm that they were given the opportunity to read it prior to surgery. Regulators could impose fines or other penalties on companies that sell implants to doctors. Within 30 days, the rules will be in effect.
The FDA and other regulators around the world have been grappling with the link between rare cancers and a type textured implant. This is on top of another issue that involves tens of thousand of people who believe their implants are responsible for other health issues such as rheumatoid and chronic fatigue, muscle pain, and even muscle pain.
FDA was concerned enough to hold a public advisory meeting in 2019. The new proposals were then made to provide more information to patients about safety issues.
These devices are made with a silicone shell and can be filled with saline or silicon. The FDA regulations provide current recommendations for routine screening to detect potential implant ruptures.