Be Informed – Allergan Textured Implant Recall

On July 24, 2019, breast implant maker Allergan announced a global recall of their Biocell saline and silicone-filled textured breast implants and tissue expanders after the U.S. Food and Drug Administration (FDA) alerted the company to a heightened risk of cancer with these devices.

The recall comes after data showed Allergan’s Biocell textured implants were linked to a rare type of cancer called anaplastic large-cell lymphoma (ALCL). Lymphoma is a cancer of the lymphatic system. Although this is a very rare occurrence, patient safety is a priority. Biocell implants account for just 5% of the U.S. market. The vast majority of breast implants have a smooth surface. The recall does not affect smooth surface implants or other textured implants under the Microcell brand.

It is important to note, the FDA does not recommend removal or replacement of implants in patients that are asymptomatic and have not tested positive for ALCL because this type of cancer is so rare.

The FDA stated that the most recent figures show more than 80% of the known 570 lymphoma cases worldwide are linked to Allergan’s Biocell textured implants. The new numbers are still very low considering there are estimated to be more than 10 million women around the world with breast implants.

If you are experiencing symptoms such as swelling and/or pain in one or both breasts, it is recommended that you schedule an evaluation with Dr. Nichter or Dr. Horowitz so it can be determined if you need diagnostic testing. Should it be determined testing is recommended, one of the following will be ordered.

• Cell cytology, CD30 immunohistochemistry, or flow cytometry.

• Allergan will cover the cost of the test, if conducted after January 1, 2019, regardless of the results (positive or negative).

If you test positive, you may be eligible for reimbursement up to $7,500 for your surgery costs in addition to receiving new implants at no cost.

Please contact our office if you have questions or would like to schedule an evaluation.