In an official statement released Wednesday, the FDA requested that breast implant manufacturers impose strict warning standards on their products. The statement comes after numerous cases of lymphoma, an immune system cancer, have been linked to certain kinds of breast implants.
The agency called for breast implant manufacturers to include bold, noticeable warnings on their products to alert customers to possible health risks. The agency recommends that breast implants include a boxed warning, also known as a “black box warning“. The FDA describes the black box as its strictest warning, “designed to call attention to serious or life-threatening risks.”
Recent studies have suggested that breast implants, particularly textured silicone implants, create a heightened risk of lymphoma in implant patients. The phenomenon is termed “breast-implant-associated anaplastic large cell lymphoma”, better known as BIA-ALCL. The FDA has reported 573 cases of BIA-ALCL worldwide, with 33 fatalities so far.
Numerous lawsuits have resulted from BIA-ALCL diagnoses, with plaintiffs alleging that they were unaware of the risks of textured breast implants when they underwent their procedures. Many patients report that they were not warned at all of the risk of lymphoma, and that they would not have elected to undergo breast implant surgery if they had been properly informed.
In light of such allegations, many have pointed the finger at the FDA, arguing that the agency should require manufacturer transparency and warnings on breast implants. Although the FDA has published several reports on BIA-ALCL, its statement on Wednesday was the first meaningful step towards holding manufacturers accountable for informing patients of the severe health risks associated with their products.
For more information about BIA-ALCL, its effects, and pending litigation, click here.
If you or a loved one have been diagnosed with BIA-ALCL after receiving breast implants, call the Tennessee breast implant lymphoma attorneys at David Randolph Smith & Associates. Our experienced BIA-ALCL lawyers are prepared to guide you on the next steps in your breast implant lymphoma case.