ALLERGAN, an Irish-based pharmaceutical company have had their breast implants pulled from US markets by the Food and Drug Administration (FDA) after more than 500 cases of uncommon cancer worldwide were linked to the product.
The link is to various forms of Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA-ALCL).
Research has shown that the risk of cancer caused by Allergan’s implants is six times greater than the risk from other manufacturers.
The sale of Allergan’s implants were halted in Europe in December and now the US has followed suit after the high levels of risk were further examined.
“Although the overall incidence of BIA-ALCL appears to be relatively low, once the evidence indicated that a specific manufacturer’s product appeared to be directly linked to a significant patient harm, including death, the FDA took action to alert the firm to new evidence indicating a recall is warranted to protect women’s health,” said FDA Principal Deputy Commissioner Dr. Amy Abernethy in a statement.
The FDA have recorded 573 cases of BIA-ALCL worldwide, and 481 of those are linked to implants manufactured by Allergan.
BIA-ALCL is not breast cancer, but a cancer of the immune system, which causes swelling and skin irritation and pain. After a few years it also causes a malignancy of the immune system.
The FDA have recommended that women who aren’t experiencing any of the symptoms should not seek to get their implants removed.
80% of the Dublin-based company’s sales come from the US, but the majority of Allergan’s implants are sold around Europe, with smoother alternatives offered in America.