Approximately 4% of women in the United States have breast implants. Though this percentage is relatively low, this seemingly small percentage point accounts for millions of women. Some women seek out this treatment for purely cosmetic reasons, while others may seek them in connection with serious medical issues. For instance, it is not uncommon for breast cancer survivors, or women with a family history of breast cancer to undergo surgeries called “mastectomies” to remove their breast tissue. Often, these women then undergo breast reconstruction surgery and may use implants in place of the tissue they had removed. It is a nightmare for patients to discover that something implanted inside their bodies has been recalled because it may pose a risk of causing cancer. Unfortunately, Allergen, a manufacturer of the breast implants, has recalled their textured breast implants called BIOCELL because it may be directly linked to a type of cancer called implant-associated anaplastic large cell lymphoma (BIA-ALCL).
“Manufacturers must provide consumers with safe products, and simply issuing a recall for a dangerous or defective product does not release the company from liability for any damage their product may have caused,” Attorney Robert Marcus of Marcus & Mack explained.
These implants were recalled by Allergen as a precaution when the FDA discovered that some cases of BIA-ALCL that were reported were in patients that had Allergen’s BIOCELL breast implants. While it is important to comply with product recalls for consumer safety purposes, it is also important to note in this instance, that only a small percentage of women with breast implants have BIOCELL implants. Additionally, the FDA states that BIA-ALCL is a rare, slow-growing form of cancer that will not affect the vast majority of people with breast implants.
The FDA recommends that individuals who have BIOCELL breast implants consult with their doctor to determine the patient’s risk level and ensure that they do not have any signs or symptoms of BIA-ALCL. If no symptoms of the cancer are present, the FDA does not recommend removing the recalled breast implants. Instead, the FDA recommends patients familiarize themselves with the signs and symptoms of BIA-ALCL and simply monitor their health and consult their doctor should any symptoms arise.