FDA has finalized labeling guidance for breast implant manufacturers, including a boxed warning informing patients that the products have been associated with a type of immune system cancer. According to news reports, the product labeling should also incorporate a patient decision checklist, rupture screening recommendations for silicone gel-filled breast implants, materials description and patient device cards, the agency said.
In the United States, J&J brand Mentor, medical aesthetics company Sientra and Allergan still sell breast implants even though Allergan had to remove certain textured implants from the U.S. market last year after they were linked to Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL). FDA’s breast implant labeling guidance was developed with input from a 2019 expert advisory panel that heard from a number of patients who testified about their experiences after developing BIA-ALCL.
Advice and Recommendations for Patients
FDA said its intent in issuing the labeling guidance is to address concerns that some patients are not getting information about the risks or understanding how serious they may be. While the risk of developing BIA-ALCL is relatively lower, the cancer is serious and could lead to death. Apart from cancer, some breast implant patients have reported systemic symptoms such as exhaustion, loss of memory, rashes, and joint pain. The term “breast implant illness” has been used to describe these types of symptoms.
The FDA warning alerts consumers about the risk of BIA-ALCL, especially with textured breast implants such as the ones recalled by Allergan rather than the smooth implants. The guidance from the FDA also advises that patients should receive a decision checklist and information brochure highlighting the risks of BIA-ALCL, systemic symptoms, surgical risks, situations in which the devices should not be used, considerations for a successful implant candidate and a discussion of options other than breast implants.
FDA also recommends physicians provide a device card to patients after surgery that includes the product’s serial or lot number, device style and size, unique device identifier, web link to access the most current patient information, a statement about the boxed warning, and a toll-free number to the breast implant manufacturer.
Product Liability Issues
Product defects and design defects in breast implants are not just limited to textured breast implants. Patients may suffer serious side effects because of leaking or ruptured breast implants as well. If you suspect that you have been adversely affected as a result of receiving a defective breast implant, an experienced product defect lawyer can help you better understand your legal rights and options.
Source: https://www.medtechdive.com/news/fda-finalizes-black-box-warning-for-breast-implants/586033/
