Monday, April 25, 2011

More on Link Between Breast Implants and ALCL

I have written about this previously. 

ALCL and Breast Implants – an article review (March 9, 2011)

ALCL and Breast Implants (January 31, 2011)

Breast Implants and Lymphoma Risk (June 29, 2009)

 

A quick review:  In January, the Food and Drug Administration (FDA) released a safety alert warning of the possible association of acute large cell lymphoma (ALCL) with breast implants.

After the Plastic Surgery Societies got through being defensive, they did the right thing  reviewed the literature (4th reference below) and the Plastic Surgery Foundation and the Aesthetic Surgery Education and Research Foundation commissioned RAND to conduct an exhaustive review of the medical literature and organize a panel of medical experts to evaluate the evidence for a potential link and its implications.

The results of this RAND review confirmed breast implants do indeed appear to be associated with the rare form of lymphoma ALCL.  The report notes there is not yet evidence to show that the cancer is caused by implants or to suggest an underlying mechanism for how the disease might develop.

The study, published online (3rd reference below) by the journal Plastic and Reconstructive Surgery, also finds that the disease takes a slow course and can be controlled by surgical removal of the implant and surrounding capsule.

The conclusions are based on an exhaustive review of the medical literature regarding breast implants and anaplastic large cell lymphoma or ALCL, a type of immune system cancer that was first linked to breast implants more than a decade ago, and input from a multidisciplinary expert panel.

"Much more research is still needed to explore the link between breast implants and ALCL and the clinical significance of this rare disease, but our findings provide useful information for both patients and physicians in the near term," said Dr. Soeren Mattke, the study's senior author and a senior scientist at RAND, a nonprofit research organization.

The panel concluded that the evidence suggests an association between breast implants and anaplastic large cell lymphoma, but cannot definitely prove that implants cause the disease nor explain how the implants might trigger ALCL.

The experts recommended that the appearance of a fluid-filled sac near a breast implant six or more months after surgery should lead to a thorough diagnostic evaluation for anaplastic large cell lymphoma. They also concluded that the diagnosis of anaplastic large cell lymphoma should result in a complete evaluation to rule out spread of the disease outside of the breast capsule (the lining that forms around the implant), followed by removal of the implant and capsule.

Experts did not believe that disease confined to the implant capsule warrants radiation treatment or chemotherapy after surgery and expressed the belief that the risk of recurrence or development of systemic disease following surgical removal was low, but that close clinical follow-up was necessary.

The U.S. Food and Drug Administration and the American Society of Plastic Surgeons recently announced an effort to create a registry that will collect information on women with breast implants who have been diagnosed with anaplastic large cell lymphoma in order to gather information that will help increase understanding of the disease.

Health care professionals are requested to report all confirmed cases of ALCL in women with breast implants to Medwatch, the FDA’s safety information and adverse event reporting program. Report online at http://www.fda.gov/Safety/MedWatch/default.htm or
by calling 800-332-1088.

 

 

REFERENCES

1.  RAND CorporationPress Release April 19, 2011

2.  FDA safety alert; January 2011

3.  Anaplastic Large Cell Lymphoma and Breast Implants: Results From a Structured Expert Consultation Process; Kim, Benjamin; Roth, Carol; Young, V. Leroy; Chung, Kevin C.; van Busum, Kristin; Schnyer, Christopher; Mattke, Soeren; Plastic & Reconstructive Surgery., POST ACCEPTANCE, 15 April 2011; doi: 10.1097/PRS.0b013e31821f9f23

4.  Anaplastic Large Cell Lymphoma and Breast Implants: A Systematic Review; Kim, Benjamin; Roth, Carol; Chung, Kevin C.; Young, V. Leroy; van Busum, Kristin; Schnyer, Christopher; Mattke, Soeren; Plastic & Reconstr Surgery., POST ACCEPTANCE, 25 February 2011; doi: 10.1097/PRS.0b013e3182172418

1 comment:

Cynthia Bailey MD, Dermatologist said...

I really appreciate your comments on this subject. None of we physicians ever wants to look back over our career and learn that we had recommended something that might have harmed some of our patients, people who have trusted us and whom we care so much about. It's one of my biggest fears, and it guides all of my medical decisions. Medical science is always evolving so there's just no guarantees though.