Allergan has recalled the company's textured breast implants. The company announced the global recall as part of a request by the FDA. "Biocellsaline-filled and silicone-filled textured breast implants and tissue expanders will no longer be distributed or sold in any market where they are currently available," states the company.
The recall comes two years after 359 reports of non-Hodgkin's lymphoma, linked to certain breast implants, were sent to the United States Food and Drug Administration (FDA). The FDA has been investigating the matter since 2011.
FDA officials claim that the risk is low, but requested the recall after evidence found that the product can be directly linked to patient harm and death.
FDA officials are not urging the public to have the implants removed, but the agency is going to provide information for providers and patients to consider. Anyone that has had a textured implant implanted and is suffering from symptoms will want to discuss the option of removal with their doctor.
The recall comes after the release of a previous report in February which found that the implants caused implant-associated anaplastic large cell lymphoma. There have been 116 new cases of rare cancer and 24 deaths since the February report has been released. The rise in occurrence has spurred the agency's decision to demand a recall.
Biocelltextured implants were found to cause a six times higher risk of cancer versus other textured implants. The agency claims to have been monitoring reports of the disease since 2011, and numerous scientific studies have been published linking the implants to cancer.
The FDA claims that there have been 33 patient deaths worldwide and 573 cases of lymphoma. Allergen's implant was linked to 12 out of 13 patients who have known implant manufacturers. Out of the 573 cases of cancer, 481 involved Allergen's product.
Scientists are still trying to determine why the textured implant increases cancer risks, but it is the belief that the texture rubs on the scar tissue in the body which results in an immune response causing cancer. The response is what researchers believe will lead to the person suffering from lymphoma.
Months ago advisers claimed that there was a lack of information linking implants and their health risks to women. The conclusion was that there was not enough scientific evidence linking breast implants to cancer. Allergen is asking that all unused products be returned and claims that the company will work with any customer that has unused products.
