Statement of Dr. Diana Zuckerman, President, National Center for Health Research on July 24 Announced Recall of Allergan Biocell Breast Implants and Expanders
“The FDA announced today that at its request, Allergan is implementing a worldwide recall of their Biocell textured breast implants and expanders. This recall is an important step toward reducing the risk of a type of cancer of the immune system called Anaplastic Large Cell Lymphoma (ALCL) caused by breast implants. Many other countries had already banned this type of Allergan textured breast implant, but the FDA had previously stated that such a ban was premature. However, it was inevitable that either the company would voluntarily decide to withdraw them from the market to protect from lawsuits, or the FDA would persuade Allergan to do so. It is a little surprising that the FDA is taking credit for the recall, since most recalls of medical devices are described by the companies as voluntary.
“When women decide to get breast implants for reconstruction after mastectomy or for breast augmentation, they should not be putting their lives at risk for lymphoma. This recall will reduce that risk but it won’t eliminate it.”
For more information, see the FDA’s Press Release here.