The FDA Has Added A Boxed Warning To The Package Of Breast Implants

The FDA Has Added A Boxed Warning To The Package Of Breast Implants

Several modifications to breast implant laws were announced by the US Food and Drug Administration on Wednesday, including new labeling that includes a boxed warning and a patient checklist, informing individuals that implants are not a medical device that will last a lifetime.

The FDA Has Added A Boxed Warning To The Package Of Breast Implants

In 2019, the FDA decided to restrict the sale of breast implants to only health care providers who provide patients with an industry-standard checklist explaining the risks after hearing testimony from women who claimed their doctors failed to adequately warn them about the potential health complications of breast implants. Patients will have to complete a checklist to show that they understand the risks to their health in order to comply with the new standards, which require doctors to walk them through these potential challenges.

The FDA Has Added A Boxed Warning To The Package Of Breast Implants

Implants that are more than a decade old come with a host of health risks that may require additional surgical intervention. Fatigue, joint stiffness, exhaustion, brain fog, and memory loss are just a few of the symptoms that some implant patients have reported. These will be listed in the warning and on the safety checklist. Discussing whether or not implants are linked to an uncommon form of immune-system cancer that manifests as swelling in the lymph nodes will also be covered (BIA-ALCL). In the future, patients with surfaced breast implants are more likely to be diagnosed with breast cancer than those having smooth implants. Many of the reported cases were tied to Allergan’s textured implants, which the company voluntarily recalled due to safety concerns in April of this year.

According to the Journal of the American Society of Plastic Surgeons, breast implants have been linked to health problems in women since the 1960s. The FDA requires clinicians to report anaplastic large cell lymphoma cases in breast implant recipients to a register they manage.

Despite being one of the five most popular cosmetic surgical operations, the number of people who have had breast augmentation surgery has declined by 33% in 2020 from the previous year. According to research by the American Society of Plastic Surgeons, breast implants are expected to be performed on roughly 200,000 people in 2020. Breast augmentations were down the greatest, although plastic surgery procedures as a whole were down.

More than 75% of Americans who get implants do so for aesthetic reasons. Breast cancer surgery results in the rest of the women receiving them.FDA recommendations for silicone gel-filled breast implant rupture screening have also been updated, as have the rules for what manufacturers must conduct post-approval research.” The FDA has sought new ways to expand patients’ access to clear and accessible information regarding the advantages and dangers of breast implants,” said Dr. BinitaAshar, director of FDA’s Office of Surgical and Infection Control Devices at the Center for Devices and Radiological Health. The FDA is working to improve the safety criteria for manufacturers in an effort to close information gaps for women considering breast implant surgery.