On Wednesday, US health regulators finalized stricter warnings for breast implants, including a new requirement for people to receive detailed information about their potential risks and complications before receiving them.
The FDA has announced new regulations, mainly targeting implant manufacturers, who must also add boxed warning messages – the most serious type – to their written patient materials.
The FDA requirements are the latest step in a decades-long effort to address safety concerns with devices primarily used for breast augmentation, the most common cosmetic surgical procedure in the U.S. Approximately 400,000 people receive implants each year, 100,000 of them after cancer surgery.
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The FDA originally proposed these rules as voluntary measures in 2019, but the environment makes them legal requirements for breast implant manufacturers, including leading manufacturers such as the Mentoring division of Johnson & Johnson and Allergan.
At the most critical point, plastic surgeons and other medical professionals working with implants should provide their patients with a checklist detailing possible side effects such as scarring, pain, rupture, and even a rare form of cancer. The checklist also clarifies that breast implants often require reoperations and should not be regarded as lifelong devices.
Doctors must sign the document and certify that the recipient has been given the opportunity to review it before the operation. Companies that sell implants to doctors who do not comply with the regulations may face fines and other penalties from regulators. The rules take effect after 30 days.
In recent years, the FDA and regulatory bodies around the world have tried to establish a link between a rare cancer and a type of textured implant. This is already a separate issue, with tens of thousands of people involved, who blame their implants for a host of other health problems, including rheumatoid arthritis, chronic fatigue, and muscle pain.
Concerns prompted the FDA to convene a public consultation in 2019, after which new proposals were made to provide patients with more information on safety concerns.
The devices have a silicone outer shell and are filled with saline or silicone. FDA regulations also provide updated guidelines for routine screening for potential implant ruptures.
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