Textured breast implants made by Allergan that have been linked to an unusual cancer are being recalled in the United States at the request of the Food and Drug Administration, and will also be recalled globally, the agency announced on Wednesday.
The F.D.A. decision, based on an increasing number of cases and deaths from the implant-associated cancer, lags far behind action in Europe, where the Allergan devices were effectively banned late last year.
Worldwide, 573 cases and 33 deaths from the cancer have been reported, with 481 of the cases clearly attributed to Allergan Biocell implants, the F.D.A. said. Of the 33 deaths, the agency said its data showed that the type of implant was known in 13 cases, and in 12 of those cases the maker was Allergan.
“The data regarding deaths was particularly informative of our decisions,” said Dr. Jeffrey Shuren, director of the F.D.A.’s Center for Devices and Radiological Health.
The disease is anaplastic large-cell lymphoma, a rare cancer of the immune system. It is not breast cancer, but develops in tissue around the implant. In most cases, removing the implant and the scar tissue around it cures the cancer, but if it is not detected early it can spread and kill the patient. The condition has occurred with implants placed for cosmetic breast enlargement and with those used for reconstruction after mastectomy for breast cancer. The F.D.A. first recognized the link to breast implants in 2011.
The lymphoma is rare, given that millions of women have breast implants. Breast enlargement is the most popular type of plastic surgery in the United States, with more than 300,000 operations performed in 2017, a 3 percent increase over 2016, according to the most recent data from the American Society of Plastic Surgeons. About 100,000 other women received implants in 2017 during reconstructive surgery after mastectomy for breast cancer in the United States.
Despite the low incidence of the lymphoma, the F.D.A. said in a safety communication for patients that “at the present time, we believe all individuals who are considering a breast implant of any type be informed of the risk of developing” the disease.
The Biocell textured implants carry a risk that is about six times that of other textured implants sold in the United States, the agency said. Hundreds of thousands of women in the United States have Biocell implants, Dr. Binita Ashar, director of the F.D.A.’s Office of Surgical and Infection Control Devices, said at a news briefing on Wednesday about the recall.
The main symptoms of the lymphoma are usually swelling and fluid accumulation around the implant. If those symptoms occur, the fluid should be drained and tested for the cancer.
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, a major international manufacturer of breast implants.
“Patient safety is a priority for Allergan,” the company said in a statement, “and patients are advised to speak with their plastic surgeon about the risk and benefits of their implant type should they have any concerns.”
Dr. Mark Clemens, a plastic surgeon at the M.D. Anderson Cancer Center in Houston, who has been studying the lymphoma, said he supported the F.D.A.’s decision. “We have tried to give them all the data and the information that they need to make this decision,” he said.
CreditThompson et al., via U.S. Food and Drug Administration
The agency held two days of emotionally charged meetings about breast implants in March, hearing from women who had had lymphoma and others who had developed debilitating symptoms like pain and fatigue after receiving implants, which the F.D.A. had acknowledged might occur. The lymphoma patients called for a ban on textured implants.
But in May, the agency declined to ban the implants, saying that the lymphoma risk was low and that there was not enough data to justify taking the devices off the market. But a significant increase in the number of cases and deaths led the agency to act on Wednesday.
Raylene Hollrah was treated for the implant-associated lymphoma in 2013 and has become an advocate for patients. “It’s a win for us, finally,” she said. “We’ve been advocating for a long time, and it’s the right thing to be done. We’re just disappointed it took this long.”
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.
Although several companies make textured implants, a great majority of the lymphoma cases have occurred in women with the Allergan products.
Allergan’s 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. Worldwide, 38 countries have banned textured implants, Dr. Clemens said.
Allergan said on Wednesday that it was halting sales of the textured implants worldwide.
“When women decide to get breast implants for reconstruction after mastectomy or for breast augmentation, they should not be putting their lives at risk for lymphoma,” said Diana Zuckerman, president of the National Center for Health Research, who has studied implants.
She added that the recall would reduce the risk but not eliminate it, because some women with other types of implants also had the lymphoma.
