Allergan Inc. issued a worldwide recall of its Biocell textured breast implants as well as tissue expanders due to a link with a rare type of cancer. The announcement came after the U.S. Food and Drug Administration requested that the company voluntarily recall the products after the implants were linked to breast implant-associated anaplastic large cell lymphoma cases, or BIA-ALCL, CNN reported.
The FDA announced in a press release that Allergan was taking action as a “precaution following notification of recently updated global safety information concerning the uncommon incidence of breast implant-associated anaplastic large cell lymphoma.”
The recall includes 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. Also included in the recall are tissue expanders patients may have used prior to surgery, which included Natrelle 133 Plus Tissue Expander and Natrelle 133 Tissue Expander with Suture Tabs.
Textured breast implants are less common in the U.S., with sales totaling less than five percent of all breast implants sold in the country, the FDA said.
However, Dr. Binita Ashar said many women could be affected by the recall.
“It’s our estimation that hundreds of thousands of women have these implants,” she said during a press conference on Wednesday.
CNN reported that the FDA first became aware of a possible association between breast implants and or BIA-ALCL in 2011. The FDA does not recommend having the implants removed because of potential risks. Instead, those with implants are advised to monitor the area around the implants for any noticeable changes. Anyone experiencing symptoms of BIA-ALCL should speak with a health care professional. Symptoms of the cancer include swelling or pain in the area, which can occur years after the initial surgery.
Worldwide, 573 cases of BIA-ALCL have been related to the implants. In addition, 33 patients have died from it. That number is up from last year, according to the FDA.
The agency said it would continue to analyze data and take additional action when necessary.
The FDA is also considering recommendations for changing how breast implants are labeled. Some changes may include a warning along with a checklist to help women consider the benefits and risks of getting breast implants.
While most women don’t ever experience serious complications, they are not meant to last a lifetime.
“Breast implants are not meant to be lifetime devices. They have a lifespan, and that might range from seven to 10-plus years, based on the implant and patient,” Dr. Tommaso Addona, president of the Long Island Plastic Surgical Group, said in March, per CNN.