While any link to cancer is worrisome, the increased risk among girls with implants, if real, is incredibly tiny, the agency said. “We’ve identified sixty cases of ALCL within the breast among an estimated five [million] to ten million with breast implants worldwide,’’ Dr. William Maisel, chief scientist and deputy director for science within the FDA’s Center for Devices and Radiological Health, said at a news conference.
That particular cancer, though, normally happens within the breast in just 3 girls in one hundred million, therefore the dozens of additional cases — in girls who had either saline or silicone implants for augmentation or reconstruction — that the FDA has collected in its database and from reviewing revealed case reports purpose to potential hassle.
I think it’s a true association; we just don’t find this kind of thing occurring spontaneously in the breast,’’ said Dr. Bruce Chabner, an oncologist and director of clinical research at the Massachusetts General Hospital Cancer Center. Chabner, a paid consultant for implant maker Allergan, served on the company’s scientific advisory board for the past year to examine ALCL reports in those with implants.
The FDA is calling on plastic surgeons to report any diagnoses of ALCL in women with breast implants, but Maisel emphasized that only women who are having trouble with their implants — pain, lumps, swelling, or asymmetry — need to see their doctor for further evaluation.
If symptoms are determined to be caused by excess fluid around the implant, the FDA recommends that surgeons take a small sample and send it to a pathology lab for testing, said Maisel. But he said that “women with no symptoms just require routine follow-up and don’t need prophylactic removal of their implants.’’
Breast implants — once blamed for autoimmune disorders and other systemic diseases — are largely viewed by the medical community as safe and much improved since they were first introduced nearly 50 years ago. They are used for cosmetic augmentation but also by breast cancer patients who opt for reconstruction after a mastectomy.
This report is obviously concerning, but I wouldn’t discourage my patients from getting implants for this reason,’’ said Mehra Golshan, director of breast surgical services at the Dana-Farber Cancer Institute in Boston. Still, women should be told about the possible association, he said, and should factor it in when considering their options for breast reconstruction.
In a statement, Allergan said it supports the FDA’s stance and its recommendations to patients and doctors; the company said it will “continue all efforts to collect and analyze further information about the very rare occurrence of ALCL in patients with breast implants.’’
Mentor Worldwide, the other implant maker, said in a statement that it also “concurs with the FDA’s position.’’
Most likely, the FDA will receive more reports of ALCL cases in women with implants, and Chabner said those will be vital for determining just how the implants might trigger lymphoma and what the best course of treatment is for this rare cancer.
One study suggests implants could lead to mutations in the ALK gene, which is associated with anaplastic lymphomas, while case reports reviewed by Chabner indicate the cancers may be less aggressive than typical ALCL. Often, he said, they were successfully treated simply by removing the implant, fluid, and surrounding scar tissue. Only one of the cancers he reviewed become life-threatening.
Maisel said the FDA is requiring the two implant manufacturers to continue safety studies, including one with more than 40,000 patients. The American Society of Plastic Surgeons announced that it is establishing a national registry for breast implants in collaboration with the FDA to monitor safety issues.