Breast implants are used in both breast augmentation surgery (to increase the breast size) and in breast reconstruction (to replace breast tissue that has been removed due to cancer or trauma or that has failed to develop properly due to a severe breast abnormality).
Allergan Inc.’s breast implants include saline and silicone devices used in breast augmentation and reconstruction. The company is one of the largest breast implant manufacturers in the world and started selling breast implants in 2006. Allergan’s flagship breast implant brand is Natrelle, but it also sells implants under its subsidiaries Inamed and McGhan. The manufacturer received approval from the U.S Food & Drug Administration (FDA) on 11/17/2006.
The popular product, its textured implants, is linked to a rare type of cancer called breast implant-associated anaplastic large cell lymphoma, or BIA-ALCL. The disease is a type of non-Hodgkin lymphoma.
On July 24, 2019, Allergan announced a global recall of Biocell textured breast implants and tissue expanders after the U.S. Food and Drug Administration (FDA) requested the recall.
The recall came after a rare type of cancer called anaplastic large-cell lymphoma (ALCL) has been linked to textured breast implants. Lymphoma is a cancer of the lymphatic system.
Currently, 38 other countries have recalled this implant because of its link to ALCL.
The FDA also updated the number of worldwide cases of ALCL associated with breast implants: 573 women have been diagnosed, and 33 women have died from the disease.
Of the 573 cases of ALCL, 481 are attributed to Allergan implants. Of the 33 deaths, the FDA reports that the implant maker was known for 13 women. Of these 13 women, 12 of them were confirmed to have an Allergan breast implant at the time of their ALCL diagnosis.
Breast implants are used in both breast augmentation surgery (to increase the breast size) and in breast reconstruction (to replace breast tissue that has been removed due to cancer or trauma or that has failed to develop properly due to a severe breast abnormality). Breast implants may also be used in revision surgery to correct or improve the result of a primary breast implant surgery. Tissue expanders are used in breast reconstruction following mastectomy, treatment of underdeveloped breasts, and treatment of soft tissue deformities. The expander is intended for temporary (less than six months implantation under the skin (subcutaneous) or under the muscle (submuscular).
The FDA requested that Allergan recall all BIOCELL textured breast implants and tissue expanders marketed in the U.S. due to risk of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), a cancer of the immune system. Based on the currently available information, the FDA's analysis demonstrated that the risk of BIA-ALCL with Allergan BIOCELL textured implants is approximately 6 times the risk of BIA-ALCL with textured implants from other manufacturers marketing in the U.S. and continued distribution of Allergan's BIOCELL textured breast implants would likely cause serious, adverse health consequences, including death, from BIA-ALCL.
In February 2019, the FDA warned that breast implants may cause BIA-ALCL, a type of lymphoma. Unlike traditional breast cancer, which affects the breast tissue itself, this cancer develops within the scar capsule that forms around the breast implant during the healing process.
The link between breast implants and cancer was first identified in 2011, but a review of reports prompted the FDA to send out a larger safety announcement as well as contact doctors about the issue.
In early April 2018, France became the first country to ban certain textured breast implants due to their association with breast implant-linked lymphoma.
The disease that has come to be known as breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) is not breast cancer.
Rather, it is a variant of the same lymphoma that has been linked to the use of the herbicide glyphosate, a malignancy that attacks the immune system, specifically targeting the white blood cells, or T-cells. According to the American Cancer Society, ALCL is the result of a genetic mutation, which causes the T-cells to produce excess quantities of a specific protein known as anaplastic lymphoma kinase or ALK-1.
