RIO DE JANEIRO, BRAZIL – Irish Silicone implant manufacturer Allergan has announced a worldwide recall this Wednesday, July 24th, in reaction to the warning that its products may increase the risk of cancer.
The alarm was prompted by the Food and Drug Administration (FDA), the U.S. regulatory agency, which said it had information concerning the product’s link with the majority of cases of a rare type of lymphoma.
In a statement also released in Brazil, Allergan said that the recall would include the following products: Natrelle Tissue Expander, Natrelle Textured Breast Implant, and Natrelle Double Lumen Breast Implant.
The company states that it is taking action as a precaution “after having been notified of recently updated safety information regarding the unusual incidence of large-cell anaplastic lymphoma associated with the breast implant (BIA-ALCL) provided by the FDA.”
The company added that breast implants and texturized tissue expanders filled with Biocell saline and silicone would no longer be distributed or sold in any market where they are currently available.
“From now on, surgeons should no longer use the mentioned prostheses and tissue expanders, and all products in stock should be returned to Allergan. Allergan will provide all information and guidance to customers on how to return unused products,” it stated in a public announcement.
The FDA is not recommending the removal of implants because cancer is rare, but considered that a medical follow-up is recommended in case of symptoms, such as pain and swelling. Health authorities began linking implants to cancer in 2011.
The condition is not a type of breast cancer, but rather a lymphoma that grows in the breast scar tissue. Growth is slow and can typically be treated by the surgical removal of implants.
The agency stated that over eighty percent of the 570 confirmed cases of lymphoma in the world are linked to Allergan’s implants. The decision was taken after the FDA received 116 cancer reports. These cases have led to an increase in the number of deaths, from nine to 33; at least twelve of them concern women with Allergan implants.
The company said patient safety is their priority. “We advise patients to talk to their doctors regarding the risks and benefits of their type of implant should they have any concerns.”
Allergan stated that it is available to answer questions from patients and doctors by telephone 0800 14 4077, Monday to Friday, from 8 AM to 5 PM.