Increase in breast implant cancer

More cases of an unusual cancer linked to breast implants have been reported to the US Food and Drug Administration, the agency said last week.

The case count rose in the past year, to 414 cases from 359, the agency said in an update on its website. The number of deaths it has recorded, nine, has not changed from one year ago; a professional society of plastic surgeons is now reporting 16 related deaths.

The FDA’s figures include cases from the US and other countries. The agency began publicly reporting on the problem in 2011, and some of the increase may be due to increased awareness and diagnosis. The disease is not breast cancer but is a malignancy of the immune system called breast implant-associated anaplastic large-cell lymphoma.

When detected early, it can usually be cured by surgery alone, by removing the implant and the capsule of scar tissue that forms around it. But some women have needed more extensive treatment, with chemotherapy and radiation, and the disease can be fatal.

A major symptom is swelling around the implant, which has occurred from two to 28 years after surgery, with a median of eight years. In women with no symptoms, there is no reason to remove implants or screen for the disease, the FDA said.

The lymphoma is more likely to occur in women with implants that have a textured coating, as opposed to a smooth cover, the agency said. No connection has been found between the disease and what is inside the implants - salt water or silicone. Nor is the lymphoma associated with breast cancer: it is just as likely to occur in women who chose implants for cosmetic reasons as in those who received them during reconstructive surgery after breast cancer.

Textured implants have roughened surfaces that may act as an irritant, provoking inflammation that can lead to lymphoma, researchers say. Another theory is that the texturing might trap bacteria, and that a chronic infection could also bring on the cancer.

Doctors and patients sometimes prefer textured implants as they are less likely to shift position than smooth ones, as tissue grows into the roughened surface and holds the implant in place. In the US, most implants are smooth; textured are more popular in Europe.

The lymphoma “appears to develop exclusively in women with textured implants,” said the American Society for Aesthetic Plastic Surgery.

But the FDA said it could not state conclusively that textured implants were the sole cause, because there was not complete information in every case on what type of implants were used. Implants often have to be replaced, and if a woman with lymphoma has had both types of implants it may be hard to tell which is to blame.

Mark Marmur, a spokesperson for Allergan, a major manufacturer of implants, said the company was paying for research by outside investigators into causes of the lymphoma, working with plastic surgery societies on improved techniques, adding information about the disease to its labelling and website, and giving surgeons educational materials for patients. He said on January 1, Allergan changed the warranty on its textured implant to cover treatment for Allergan patients who received a diagnosis of implant-associated lymphoma on or after that date, regardless of implantation date. - The New York Times