Breast implant maker Allergan Inc. issued a worldwide recall Wednesday for certain textured models after regulators alerted the company to a heightened cancer risk with the devices.
The U.S. Food and Drug Administration said it called for the removal after new information showed Allergan’s Biocell breast implants with a textured surface were tied to the vast majority of cases of a rare form of lymphoma. The move follows similar action in France, Australia and Canada.
The FDA is nor recommending women with the implants have them removed because the cancer is so rare, but say they should check with their doctor if they have symptoms, which include pain and swelling.
Biocell implants feature a textured surface designed to prevent slippage and to minimize scar tissue. These models account for just 5 percent of the U.S. market. The vast majority of breast implants used in the U.S. have a smooth surface.
Wednesday’s recall does not affect Allergan’s smooth implants or a different Allergan textured implant sold under the Microcell brand.
Health authorities first linked breast implants to cancer in 2011. The disease is not breast cancer but lymphoma that grows in the scar tissue surrounding the breast. It grows slowly and can usually successfully treated by surgically removing the implants.
As recently as May, FDA said that the dander did not warrant a national ban on textured devices. But the FDA said Wednesday that new data show a direct link to cancer with Allergan’s implant not seen with other textured implants.
“Once the evidence indicated that a specific manufacture’s product appeared to be directly linked to significant patient harm, including death, the FDA took action”, said FDA deputy commissioner Amy Abernethy, on a call with reporters.
The FDA said the latest figures show more than 80 percent of the 570 confirmed cases of the lymphoma worldwide have been linked to Allergen implants. Regulators estimate that the risk of the disease is six time higher with Allergan’s implants than other textured implants than other textured implants old in the U.S.
The FDA official say the decided to act after receiving 116 new reports on the cancer. Those reports increased the number of deaths tied to the disease from 9 to 33, including at least 12 cases in women with Allergan breast implants.
FDA’s device director Jeffrey Shuren said the death increase played a significant role in their decision to seek a recall.
“Over team concluded action was necessary to protect the public health”, he said.
The new numbers still reflect a rare disease considering an estimated 10 million women globally have breast implants. The FDA estimates that hundreds of thousands of U.S. women have the Biocell implants.
There is no firm agreement on the exact frequency of the disease, known as breast implant-associated anaplastic large cell lymphoma. Published estimates ranging from 1 in 3.000 patients to 1 to 30,000 patients.
Dr Mark Clements of Houston’s MD Andersons Cancer Center said Biocell’s surface differs from other textured implants, producing a large amount of particles that shed into the body.
“But what key factor is most important, we don’t known at this time”, said Clemens, a plastic surgeon who has published extensively on the disease.
Allergan sais in a statement it would no longer sell or disturbed Biocell implants and tissue expanders, which are used to prepare patients for breast reconstruction. The company said it would direct surgeons to return used implants.
Roughly 400.000 Us. Women get breast implant each years. The devices have a silicone outer shell and are filled with either saline or silicone. Silicone-filled implants are more popular in the U.S. because they are considered more natural.
In the U.S., textured breast implants are also made by Johnson & Johnson and Sientra. A smaller manufacturer. Ideal Implant, only sells smooth implants.
Diana Zucherman, a researcher who studied breast implant safety, called the Allergen removal inevitable.