Breast implant-linked lymphoma can be controlled by removing the implant and the surrounding tissue, researchers said.
The industry-funded study by the Rand Corp. is based on a review of 29 cases of a rare form of immune-system cancer in breast-implant patients and input from a panel of experts. While the aesthetic devices have been linked to the lymphoma for more than a decade, there is still no evidence to prove the disease is caused by the implant, researchers also said in the study published online yesterday by the journal Plastic and Reconstructive Surgery.
The U.S. Food and Drug Administration issued a notice in January linking anaplastic large-cell lymphoma and breast implants. The agency didn’t recommend removal of the implants because the cancer is rare and only associated with patients who are experiencing pain, lumps, swelling or asymmetry.
“If the FDA were really concerned, they would have pulled the product from the market,” said Soeren Mattke, the study’s senior author and a senior scientist at Rand, a policy institute in Santa Monica, California. “The good news here is that in those very few cases in which this type of cancer develops it can be successfully treated by removing the implant.”
About 60 cases of the lymphoma have been reported globally in women with breast implants, including 34 published in studies from January 1997 to May 2010, the FDA said in its January notice. About three cases of these tumors in the breast are diagnosed annually per 100 million women, the agency said.
“These results take away a huge shadow from these implants,” Mattke, who heads Rand’s health consulting practice, said yesterday in a telephone interview.
Allergan Inc. in Irvine, California, and New Brunswick-based Johnson & Johnson, the world’s second-largest health products company, each control about half of the implant market, according to Gary Nachman, an analyst at Susquehanna Financial Group. About 5 million to 10 million women worldwide received implants, the FDA said.
The report identified 29 cases of the cancer involving implant patients and found 12 had a history of cancer, including eight who had had mastectomies, before the implants.
“We can’t rule out causality; we just can’t prove it,” Mattke said. “The risk of developing this lymphoma is extremely small, but this is a cosmetic procedure and you don’t die if you don’t get” an implant.