AP

FDA sets stronger safety warnings for breast implants

Oct 27, 2021, 1:46 AM | Updated: 1:47 pm

FILE - In this Dec. 11, 2006 file photo, a silicone gel breast implant is shown at Mentor Corp., a ...

FILE - In this Dec. 11, 2006 file photo, a silicone gel breast implant is shown at Mentor Corp., a subsidiary of Johnson & Johnson, in Irving, Texas. On Wednesday, Oct. 27, 2021, U.S. health regulators finalized stronger warnings for breast implants, including a new requirement that people receive detailed information about their potential risks and complications before getting them. (AP Photo/Donna McWilliam, file)

(AP Photo/Donna McWilliam, file)

WASHINGTON (AP) — U.S. health regulators on Wednesday finalized stronger warnings for breast implants, including a new requirement that people receive detailed information about their potential risks and complications before getting them.

The Food and Drug Administration announced the new regulations mainly aimed at implant manufacturers, who are also being required to add a boxed warning message — the most serious type — to their written patient materials.

The FDA requirements are the latest step in a decades-long effort to manage safety issues with the devices, which are primarily used for breast augmentation, the most common cosmetic surgical procedure in the U.S. Roughly 400,000 people get implants each year, 100,000 of them after cancer surgery.

The FDA had originally proposed the rules as voluntary measures in 2019, but Wednesday’s action makes them legal requirements for breast implant makers, including leading manufacturers like Johnson & Johnson’s Mentor unit and Allergan.

In the biggest shift, plastic surgeons and other health professionals who work with the implants must give their patients a checklist detailing possible side effects, such as scarring, pain, rupture and even a rare form of cancer. The checklist also explains that breast implants often require repeat surgeries and they should not be considered lifelong devices.

The doctors must sign the document and confirm that the recipient was given an opportunity to review it before surgery. Companies that sell implants to doctors who don’t comply could face fines and other penalties from regulators. The rules begin to take effect in 30 days.

In recent years, the FDA and regulators worldwide have grappled with a link between a rare cancer and a type of textured implant. That’s on top of a separate issue involving tens of thousands of people who blame their implants for a host of other health problems including rheumatoid arthritis, chronic fatigue and muscle pain.

The concerns led the FDA to convene a public advisory meeting in 2019 followed by the new proposals to give patients more information about safety problems.

The devices have a silicone outer shell and are filled with either saline or silicone. The FDA’s regulations also provide updated recommendations for regular screening to catch potential implant ruptures.

___

The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education. The AP is solely responsible for all content.

Copyright © The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.

AP

Image: A cargo ship is stuck under the part of the structure of the Francis Scott Key Bridge after ...

Associated Press

Authorities identify 2 bodies recovered at site of Baltimore bridge collapse

A major bridge in Baltimore snapped and collapsed after a container ship rammed into it early Tuesday, and several vehicles fell into the river below.

1 day ago

Photo: Mountaineer Jim Whittaker has died at 95....

Gene Johnson, The Associated Press

Lou Whittaker, among the most famous American mountaineers, has died at age 95

Lou Whittaker, a legendary American mountaineer who helped lead ascents of Mount Everest, K2 and Denali, has died at age 95.

1 day ago

File photo: Former Sen. Joe Lieberman speaks in Washington on Jan. 18, 2024....

Associated Press

Former Sen. Joe Lieberman, Democrats’ VP pick in 2000, dead at 82

Former U.S. Sen. Joe Lieberman of Connecticut, who nearly won the vice presidency on the Democratic ticket with Al Gore in 2000, has died.

1 day ago

islamic state attack...

Vanessa Gera, The Associated Press

What we know after the Islamic State group claims responsibility for Moscow massacre

The Islamic State group has claimed responsibility for an attack on a suburban Moscow concert hall that killed at least 133 people.

5 days ago

Moscow shooting...

The Associated Press

Russia: 60 dead, 145 injured in concert hall raid; Islamic State group claims responsibility

Assailants burst into a concert hall in Moscow on Friday and sprayed the crowd with gunfire, killing over 60 people, injuring more than 100.

7 days ago

Photo: Britain's Kate, Duchess of Cambridge visits 282 (East Ham) Squadron, RAF Air Cadets, Cornwel...

Associated Press

Kate Middleton announces she has cancer, is undergoing chemotherapy

Kate Middleton, Princess of Wales, says she is undergoing chemotherapy to treat cancer. She has been out of view since Christmas.

7 days ago

FDA sets stronger safety warnings for breast implants