Last Wednesday, January 26, 2011, the Food and Drug Administration (FDA) communicated to health practitioners and the general public about a possible association between saline and silicone breast implants and anaplastic large cell lymphoma (ALCL), a very rare type of cancer. What was not highlighted by the FDA was that seemingly no cases have been noted when “smooth shell” implants have been used.
Last April, I attended an educational meeting in Washington D.C. where Dr. Garry Brody presented updated information on his research “T-Cell Non Hodgkins Anaplastic Lymphoma Associated With One Style Of Breast Implants”. My interpretation from Dr. Brody’s presentation and data was that no confirmed cases of ALCL had been identified in smooth breast implants.
Interestingly enough, even though the FDA references Dr. Brody’s research as a source for the preliminary findings and analysis, the possible link to texture breast implants and ALCL is not mentioned. It is also important to note that there hasn’t been an actual definitive link between breast implants and ALCL.
Importantly for my patients, I have not used any textured breast implants for breast augmentation. Given this, I wanted to be able to know how to counsel my patients. At the meeting, I specifically asked (Dr. Brody) if any cases of smooth implants had been associated with ALCL and the answer was “No.”
What the FDA Did Say
The FDA stated that “data reviewed suggests that patients with breast implants may have a very small but significant risk of ALCL in the scar capsule adjacent to the implant.” It is evident how exceedingly rare the occurrence is from the data reported by the National Cancer Institute and FDA:
- ALCL is diagnosed in 1 out of 500,000 women in the United States each year appearing in different parts of the body including lymph nodes and skin.
- ALCL in breast tissue is found in about 3 out of 100 million women without implants.
- Out of the estimated 5 million to 10 million women in the United States with breast implants, the FDA has identified 34 unique cases of ALCL.
As noted by the American Society of Plastic Surgeons (an esteemed association in the plastic surgery industry and an association I am a member of):
“The ASPS and the FDA agree this extremely rare form of lymphoma is not breast cancer. While lymphomas can appear anywhere in the body, this condition appears in the scar tissue that forms around the breast implants. At this time, both the FDA and ASPS remain confident that breast implants are safe and effective.”
At Colorado Plastic Surgery Center, we continue to develop steps to prevent capsular contracture in our patients. To learn more about how we strive to prevent capsular contracture, please read: That Voo-Doo That We Do – Preventing Capsular Contracture in Breast Augmentation Patients.
Should I be worried if I have or am considering breast implants?
The FDA’s notification last week point out that there is no need for women with breast implants to change their routine medical care and follow-up. ALCL is very rare; it has occurred in only a very small number of the millions of women who have breast implants, and again, it has to date not been shown in smooth implant patients.
ALCL does have noticeable symptoms. If you have breast implants, please notify your physician if you develop any symptoms of pain, swelling, lumps or change in shape or feel of your breast implants after your breast augmentation surgery.