An October 2021 article, “FDA sets stronger safety warnings for breast implants“, addresses the Food and Drug Administration’s (FDA) new requirements for breast implant manufacturers. The new regulations will require patients receive detailed information about the potential risks and complications of implants prior to receiving surgery.
However, this is not the only change the FDA is requiring. In addition to the new regulations, breast implant manufacturers are now required to add a boxed warning message to the written patient materials.
New Regulations Laid Out By FDA
According to the same October 2021 article, “FDA sets stronger safety warnings for breast implants“, these regulations were proposed as voluntary back in 2019, but have only recently become requirements:
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.
The rare form of cancer mentioned in this October 2021 article is likely breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), a rare cancer of the immune system. BIA-ALCL has been closely linked with textured surface breast implants.
In addition to the new regulations, the FDA continues to maintain a registry where doctors can report cases of BIA-ALCL. The FDA has also updated the implant rupture screening recommendations for silicone gel-filled breast implants, as well as guidance for what manufacturers need to do with data collected from post-approval studies.
As always, we will continue to monitor the worldwide issues surrounding Biocell textured breast implants as well as other breast implants and BIA-ALCL. We will provide you with any new or relevant information.
We encourage you to visit our Breast Implants Lymphoma Cancer page on our website for more information. Please submit a free case evaluation if you or someone you know has been diagnosed with BIA-ALCL.
Written by: Lauren Schwab, Legal Assistant
Law Offices of Thomas J. Lamb, P.A.