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Plastic Surgery Organizations Tell Doctors to Downplay Risks of Breast Implant Related Cancer

By Paul Napoli

February 20, 2011

Two leading plastic surgery organizations have decided to call a cancer related to breast implants a 'condition' instead of cancer, tumor or malignancy and tell doctors they should use the same term with patients, despite new warnings from the FDA.

On January 26, 2011, the U.S. Food and Drug Administration (FDA) announced that women with saline and silicone breast implants might have a 'very small but significant' risk of developing a rare cancer called anaplastic large cell lymphoma (ALCL), an aggressive T-cell lymphoma involving cells of the immune system. While ALCL can occur anywhere in the body, in cases related to breast implants the cancer occurred in the fibrous scar tissue surrounding the breast implant.

The FDA felt that the risk warranted the updating of breast implant labeling by manufacturers to warn patients and health care professionals of the danger.

According to a letter sent to the FDA by the nonprofit organization Public Citizen, the presidents of the American Society of Plastic Surgeons (ASPS) and the American Society for Aesthetic Plastic Surgery (ASAPS) told doctors in a members-only webinar, to downplay risks of ALCL in women with breast implants by calling the cancer a 'condition.'

An excerpt from the webinar transcript sent to Public Citizen by a concerned plastic surgeon who viewed the webinar:

'[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.'

The webinar also stated that the surgery for breast implant related ALCL was a cure. However, looking at the ALCL study by the FDA, many patients required other treatments including chemotherapy and radiation. In some cases, the cancer returned even after surgery and treatment.

The New York Times viewed the webinar and confirmed that Dr. Phil Haeck, ASPS President, did recommend doctors call ALCL a condition instead of a cancer. ASPS said Public Citizen took Dr. Haeck's remarks out of context and misconstrued them.

'Far from intending to trivialize or minimize the issue, Dr. Haeck's extemporaneous remarks were well understood by physicians present to mean that the type of ALCL that has been observed in possible association with breast implants does not appear to have the malignant course of classic ALCL which is a systemic disease,' ASPS told The New York Times in a statement.

One of the organizations, the American Society of Plastic Surgeons (ASPS), is in the process of establishing a national registry for breast implants with the FDA.

'In summary, two large national organizations representing plastic surgeons have attempted to trivialize the significance of the findings of increased numbers of cases of breast implant-related lymphomas,' said Sidney Wolfe, director of Public Citizen. 'This campaign is misleading, dangerous and unethical. For the FDA to continue to work with these organizations, the agency should require them to stop such activities. For the breast implant registry that has been proposed, its control needs to be very carefully monitored by the FDA. The agency also needs to undo the misleading 'educational' campaign, one of the main goals of which must be to keep women in the dark so they will continue to ask for breast implants, unaware of this serious risk.'

Originally posted at InjuryBoard by Paul Napoli

Full post as published by New York City Personal Injury Lawyer on February 20, 2011 (boomark / email).