Global pharmaceutical company Allergan issued a worldwide recall of Biocell breast implants and tissue expanders this past Wednesday, July 24. These textured breast implants have been linked to an unusual type of cancer and are being recalled in the United States at the request of the Food and Drug Administration (F.D.A.).
The F.D.A.’s decision is based on an increasing number of cases and deaths from implant-associated cancer. Worldwide, 573 cases and 33 deaths from this cancer have been reported. 481 of these cases are clearly attributed to Allergan’s Biocell implants. While the recall was announced in the United States just this past Wednesday, these Allergan devices were effectively banned in Europe late last year.
The Biocell implants are linked to an anaplastic large-cell lymphoma, a rare cancer of the immune system, known as BIA-ALCL. While not breast cancer, the disease develops in the tissue that surrounds the implant. The condition has occurred with implants placed for cosmetic breast enlargement and with those used for reconstruction after mastectomy for breast cancer.
The FDA does not recommend the removal of these breast implant products in individuals without symptoms of BIA-ALCL, according to the agency’s announcement. The recall means that doctors and hospitals should not implant any more of the devices and should return any on their shelves to Allergan. However, individuals should be aware of the disease’s symptoms and monitor the area around the breast implants for any changes. Main symptoms include swelling and fluid accumulation around the implant. If those symptoms occur, the fluid should be drained and tested for cancer. Individuals who experience these symptoms should contact a doctor immediately.