FDA Adds Boxed Warning to Breast Implants – .

FDA Adds Boxed Warning to Breast Implants – .

After hearing testimony in 2019 from women who said their doctors had not properly warned them of the potential health complications of breast implants, the FDA said it had decided to restrict the sale of breast implants to breast implants only. health care providers who provide patients with a standardized checklist that explains the risks. The changes require doctors to explain these potential problems to patients and give the patient the option to sign the checklist to show that they have been properly informed of the risks to their health.

The older the implants, the more health risks they pose, and those risks may require additional surgery.

The warning and checklist will explain the symptoms that some implant patients have experienced, including fatigue, joint pain, fatigue, brain fog, and memory loss. He will also explain the possible link between implants and a rare type of cancer in the immune system known as anaplastic large cell lymphoma (BIA-ALCL). Cancer occurs more frequently in patients with textured breast implants than in those with smooth implants. Many documented cases were linked to textured implants produced by Allergan that the company voluntarily recalled in 2019.

The FDA maintains a registry to which doctors are supposed to report cases of anaplastic large cell lymphoma in people with breast implants.

Breast augmentation is among the top five most performed cosmetic surgeries, but the number of people who have had it decreased by 33% in 2020 compared to the previous year. Nearly 200,000 people had breast implants in 2020, according to the American Society of Plastic Surgeons’ Statistical Report on Plastic Surgery 2020. Plastic surgery procedures were down across the board, but breast augmentation was down the most.

About 75% of those who have an implant do so for cosmetic reasons. Others get them after breast cancer surgery.

The FDA has also updated the implant rupture screening recommendations for silicone gel-filled breast implants and updated its guidelines on what manufacturers will need to do with post-approval studies.

“In recent years, the FDA has looked for other ways to increase patient access to clear and understandable information about the benefits and risks of breast implants,” said Dr. Binita Ashar, director of the Bureau of Devices. Surgical and Infection Control Department at the Center for Devices and Radiological Health, said in a statement.

“By strengthening safety requirements for manufacturers, the FDA is working to fill the information gap for anyone considering breast implant surgery. ”


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