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Letter on Inaccurate Communications Regarding Risks of Breast Implant-Related Cancer

Margaret A. Hamburg, M.D.
Food and Drug Administration
Department of Health and Human Services
WO 2200
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002

Jeffrey E. Shuren, M.D., J.D.                                                                                  
Director, Center for Devices and Radiologic Health
Food and Drug Administration
Department of Health and Human Services
WO 66, Room 5442
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002

Dear Drs. Hamburg and Shuren,

A concerned plastic surgeon has just sent us portions of a transcript from a members-only webinar held on February 3, in which the 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.

The webinar was held just a week after the Food and Drug Administration (FDA) announcement on January 26 that there have been a growing number of published cases – now 34 – documenting an unusual kind of cancer (anaplastic large cell lymphoma (ALCL)) surrounding the breast in women with implants. 

When recommending during the webinar how to respond to patients who were concerned about this, Dr. Phil Haeck, president of ASPS, said, in referring to ALCL in association with breast implants:

 “[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 addition, the webinar also stated that “surgery was curative.”

Advising against the use of the words “cancer” or “tumor,” stating that this “condition” has a “benign course” and stating that “surgery is curative” when speaking to women are all strongly contradicted by evidence from the published cases.

Our detailed review of the 34 published case reports of women who developed breast implant-associated ALCL[1-18] reveals the following:

– For 17 patients (50%), the reported treatment included chemotherapy (nine patients), chemotherapy and radiation therapy (seven patients), or radiation therapy (one patient). (For most of the other patients, the course of treatment was not adequately described.)

– For 15 of these 17 patients, there were follow-up data indicating that three patients were reported to have recurrent disease after initial treatment:

o One patient after an initial clinical remission developed shortness of breath and cough and was found to have pleural and pericardial effusions and mediastinal adenopathy; pleural fluid cytology was positive for T-cell lymphoma.

o One patient developed recurrent ALCL three months after completing chemotherapy. The patient subsequently underwent implant resection and chemotherapy and was disease-free eight months after completing treatment.

o  One patient developed contralateral axillary lymph nodes after implant resection and then underwent six cycles of chemotherapy; subsequent follow-up by PET scan suggested ALCL involvement of the liver and contralateral breast.               

– Two additional patients (not among the 17 mentioned above) had recurrent disease after initial unspecified therapy, underwent stem cell transplantation, and were disease-free two years after transplantation. Thus, a total of five patients, of the 20 for whom follow-up data were available (for 14 patients, no follow-up data were available), had recurrence of their cancer.

– In addition, a total of five patients (some also in the above groupings) had evidence of ALCL involvement outside the implanted breast before or at the time that breast ALCL was diagnosed.

The ASPS and the ASAPS have ignored the currently available facts from published case reports of breast implant-associated ALCL. There are no data to support their assertion that surgery alone is curative. For most 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 findings from review of these published cases are therefore inconsistent with phrases such as a “benign course” or a “condition” rather than cancer, a tumor, or a malignancy.

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.

Finally, the literature case reports likely represent a minority of actual cases, and the total number of cases, as well as the number of ALCL patients with recurrence following treatment and spread of disease beyond the site of the breast implant is likely to be much higher.

Reasons for the number of cases or recurrences thus far reported being low include:

– Doctors likely have under-diagnosed ALCL because it is not uncommon for plastic surgeons to surgically treat a breast implant capsule/seroma in a breast augmentation patient and not send pathology or cytology specimens.

– Since the average time, as best can be determined, from implant to occurrence of ALCL is about nine years, many of the more than one million women who have had implants in the past five years may still be in the latency period for ALCL

– The median follow-up time for all of the cases of ALCL is only 12 months, meaning that one-half of the women have had follow-up for less than this time and could possibly experience recurrences in the future

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. 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.

We look forward to a prompt response to this information which, as far as the contents of the webinar, we assume you have been previously unaware. 


Sidney Wolfe, M.D.

Michael Carome, M.D.
Deputy Director
Public Citizen’s Health Research Group

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