Breast Implant Cancer Risk May be Downplayed by Plastic Surgeons, Group Says

The link between <"">breast implants and a rare form of lymphoma may be being downplayed by some plastic surgeons, according to a leading consumer advocacy group. According to a letter from Public Citizen to the head of the U.S. Food & Drug Administration (FDA), “presidents of the two leading plastic surgery organizations, the American Society of Plastic Surgeons (ASPS) and the American Society for Aesthetic Plastic Surgery (ASAPS), essentially urged members to inaccurately downplay the significance of recent evidence about the risks of breast implant-related cancer when speaking to female patients.”

Earlier this month, the FDA warned that 60 cases of anaplastic large cell lymphoma (ALCL) have been reported in breast implant patients. The agency also said review of the medical literature published between January 1997 and May 2010 revealed 34 unique cases of ALCL. Twenty-seven cases of the lymphoma identified by the FDA involved silicone breast implants. Most of the ALCL cases were diagnosed after silicone implants returned to the market in 2006. The diagnoses tended to occur a median of eight years after implantation, and involved implants for breast augmentation as opposed to reconstruction following breast cancer surgery.

According to a report in the LA Times, ALCL has been reported among women with breast implants for years. Over the past three years, a number of papers on the subject of breast implant lymphoma have been published by researchers, finally prompting the FDA to look into the issue.

According to the Public Citizen letter, which is addressed to FDA Commissioner Margaret A. Hamburg, M.D., as well as Jeffrey E. Shuren, M.D., J.D., Director, Center for Devices and Radiologic Health, the ASPS and ASAPS urged their members to downplay the cancer risks of breast implants in a members-only webinar held on February 3 – a week after the FDA’s announcement on ALCL. The group said it received transcripts from portions of the webinar from a “concerned plastic surgeon.”

In the transcript, surgeons are advised against using the words “cancer” or “tumor,” when advising patients, and told to refer this “condition” as having a “benign course” and that “surgery is curative” when speaking to women about breast implants.

At one point, Dr. Phil Haeck, president of ASPS, says he following:

“[Y]es it’s classically a malignant tumor, but it has such a benign course that when we were discussing ways to talk to the media we decided that we would call this a condition when we talked to the media, not a tumor, not a disease and certainly not a malignancy. Um, because, and I would recommend that you use the same terms with your patients rather than disturb them by saying this is a cancer, this is a malignancy. The best word is this is a condition. If you develop this condition here’s how we are going to treat it, the way we are going to diagnose this condition is this, and that’s very reassuring when you are using that word and not using the word cancer or malignancy. And I think you are certainly justified, with what we know now, in downplaying the malignant potential of these.”

In its letter, Public Citizen asserts that the “ASPS and the ASAPS have ignored the currently available facts from published case reports of breast implant-associated ALCL.” The group points out that for most ALCL patients, chemotherapy and/or radiation therapy will be part of the recommended treatment plan. Furthermore, even with chemotherapy and radiation therapy, ALCL recurrence and spread to additional sites can occur, the letter says.

The letter continues: “Such statements grossly misrepresent what is currently known about the treatment of this cancer and mislead both patients who may have received breast implant or those who may be considering undergoing breast implant surgery and the physicians who may provide care to such patients.”

This entry was posted in Breast Implants, Defective Medical Devices and tagged , , , , . Bookmark the permalink.

© 2005-2016 Parker Waichman LLP ®. All Rights Reserved.