Breast Implants Linked to Rare Cancer Are Recalled Worldwide


Ms. Hollrah, who testified at the F.D.A. meeting in March, added, “Our work is not done yet.” She said she and other advocates heard from patients every day seeking help with lymphoma, including some who had implants that were not part of the recall. Many of those patients had received incorrect diagnoses or had difficulty getting doctors to take their symptoms seriously.

The recalled devices listed by the F.D.A. 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 stock price of Allergan, which makes an array of products like Botox and treatments for dry eyes, dipped slightly on the news. It was down about 0.3 percent midday Wednesday.

F.D.A. officials said they were continuing to monitor the incidence of lymphoma linked to other types of implants and would take action against them if needed.

They also said they were considering changes to the labeling of breast implants, like adding a black-box warning to draw attention to the risks, and requiring doctors and patients considering the surgery to go over a checklist to help women understand the benefits and risks of the devices.

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 and helps hold the device in place, have been singled out as the cause of the lymphoma.

Why the texturing leads to cancer in some patients is not known. Some people may be genetically predisposed to have an inflammatory reaction to the texturing that can gradually lead to cancer, Dr. Clemens, the plastic surgeon, said. Some researchers also suspect that bacteria trapped in crevices in the roughened surface might somehow lead to the lymphoma.



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