Textured breast implants made by Allergan, linked to an unusual cancer, are being recalled in the United States at the request of the Food and Drug Administration, the agency announced on Wednesday.
Worldwide, 573 cases and 33 deaths from the cancer have been reported, with 481 of the cases clearly attributed to Allergan implants, the F.D.A. said. Of the 33 deaths, the agency said the data it had collected showed that the type of implant was known in 13 cases, and in 12 of those cases it was made by Allergan.
Women who have these implants, but no symptoms, do not need to have them removed, the F.D.A. said. The recall means that doctors and hospitals should not implant any more of the devices and should return any on their shelves to Allergan.
The recalled devices are Biocell products, including: Natrelle Saline-Filled breast implants, Natrelle Silicone-Filled breast implants, Natrelle Inspira Silicone-Filled breast implants, and Natrelle 410 Highly Cohesive Anatomically Shaped Silicone-Filled breast implants. The recall also includes tissue expanders used by patients before breast augmentation or reconstruction, including Natrelle 133 Plus Tissue Expander and Natrelle 133 Tissue Expander with Suture Tabs.
The disease linked to the implants is anaplastic large-cell lymphoma, a rare cancer of the immune system. It is not breast cancer, but it develops in tissue around the implant. In most cases, removing the implant and the scar tissue around it cure the cancer, but if it is not detected early it can spread and kill the patient. The condition has occurred in women who have gotten implants for cosmetic breast enlargement, and in women who received them for reconstruction after mastectomy for breast cancer.
The main symptom of the lymphoma is usually swelling and fluid accumulation around the implant. If those symptoms occur, the fluid should be drained and tested for the cancer.
The contents of the implant, silicone or saline, are not a factor in the lymphoma. The covering or shell of the implant, which can be either smooth or textured, is the key. Textured implants, which have a slightly roughened surface that adheres to tissue helps hold the device in place, have been singled out as the cause of the lymphoma.
Although several companies make textured implants, the great majority of the lymphoma cases have occurred in women with the Allergan products.
Textured implants account for only about 5 percent of the implants used in the United States, but have been much more common in Europe, where they have already been recalled by many countries.
Source : Nytimes
