Important Advisory for ISAPS Members

Breast Implants Non-Hodgkin's Lymphoma

Monday, March 15, 2010

The safety of our patients is our number one priority.

This Advisory has been prepared so that ISAPS members are well informed about the current course of action on this issue by ASAPS and ASPS.

1. Anecdotal cases of anaplastic, large cell lymphoma (ALCL) have been reported recently in breast implant patients. However, it is important to note that to date, the biologic course of these cases has been benign.

2. We know of four (4) confirmed cases of ALCL and another thirty-five (35) cases where ALCL was suspected, but has not been confirmed.

3. The clinical significance and incidence of these cases is, at this time, unknown.

4. Educational foundations that support plastic surgery have joined forces to support a multi-faceted research project to continue evaluating whether there is an association between breast implants and lymphoma.

5. According to industry data, approximately 5.1 million breast implant devices have been implanted in patients worldwide.

6. The medical community has studied the safety of breast implants for decades - more than any other medical device - and the overwhelming body of scientific evidence indicates they are safe and effective.

7. Being proactive, self regulating, and supporting additional research is the responsible course of action for the key medical societies in plastic surgery.

8. The American Society of Plastic Surgery (ASPS) and the American Society of Aesthetic Plastic Surgery (ASAPS), and their respective foundations, have convened an advisory council of experts from several specialties including: plastic surgery, epidemiology, pathology, and oncology to expand our knowledge base and to serve as a clearinghouse of information on this subject.

9. In addition, the National Endowment for Plastic Surgery (NEPS) is funding ongoing research at the University of Southern California.

10. Members of ASPS and ASAPS have been informed about the current and planned research and the leadership of the International Society of Aesthetic Plastic Surgery (ISAPS) has also been advised of this activity

11. Through continued research and extensive communications between medical specialists and plastic surgery societies, specific recommendations related to clinical practice will be developed and disseminated.

12. ASPS, ASAPS and ISAPS strongly support post market surveillance and ongoing monitoring research of breast implants.

Foad Nahai
President
ISAPS