Earlier this year, the San Francisco Plastic Surgery Blog reported an extremely unusual, but possible association between breast implants and a rare form of Non-Hodgkin’s Lymphoma named Anaplastic Large Cell Lymphoma or ALCL. The tumor is extremely rare. Of the 5-10 million women with breast implants, fewer than 100 cases have been identified. Literature reviews have identified 34 unique cases, and as many as 75 cases may have been identified worldwide. Because of the rare nature of the tumor, it is not clear what the association between ALCL and breast implant is.
Demographics of all Known Reported Cases
Demographics of the cases are as follows:
- Age: Median 51 years old, Range 28-87 years old
- Implant Type: Silicone 24, Saline 7, Not specified 3
- Time from implant to ALCL diagnosis: Median 8 years, Range 1-23 years
- Reason for Breast Implant: Reconstruction 11, Cosmetic 19, Not Specified 4
The American Society of Plastic Surgery (ASPS) and the American Society for Aesthetic Plastic Surgery (ASAPS) have partnered with other international plastic surgery societies like the International Society for Aesthetic Plastic Surgery (ISAPS), to provide an organized way to report, and characterize the diagnosis and treatment of ALCL since its discovery.
ALCL is Not Breast Cancer
Breast cancer dwarfs ALCL in both numbers of cases and lethality. Breast cancer has an incidence of 1 in 9 women. This means for a group of nine randomly selected women, one woman would be expected to develop breast cancer in her lifetime. The actual breast cancer rate is a little higher, and this is why routine mammograms after age 40 are so important for early detection. The risk of getting breast cancer is about 700 times higher than the risk of getting struck by lightning.
No Increased Rate of Breast Cancer for Women with Breast Implants
While the association between ALCL and breast implants is still being worked out, there is no increased risk of breast cancer in women with breast implants. In fact, the results of more than seven long-term follow-up studies show that women with implants have a lower rate of breast cancer than is expected in the general population, and higher survival rates, perhaps due to enhanced breast awareness and early detection.
Looks Like ALCL, but Doesn’t Act Like ALCL
ALCL associated with breast implants is not as aggressive as other types of ALCL. It acts more like cutaneous lymphomas than the more systemic form of ALCL. ALCL associated with breast implants has been characterized as a rarely occurring, low-grade lymphoma, that seems to grow slowly and locally. While the risk of breast cancer is 1 in 9, the risk of ALCL is less than 1 in 300,000, and most resources quote ranges of 1 in 500,000 to 1 in a million. The risk of getting ALCL associated with breast implants is 50 to 150 times lower than the risk of getting stuck by lightning.
Last week, news of the first reported death from ALCL associated with breast implants hit the French news. The details are not known at this time, and unfortunately, the case is further complicated by the use of fraudulent breast implants that were filled with industrial grade silicone instead of the required medical grade silicone. The implants were manufactured by Poly Implant Prothèses (PIP) at La Seybe-sur-Mer in the Var. The company was forced to close in March of 2010, after it was determined that the implants were filled with non-medical grade silicone gel. These implants have more gel bleed, and are ten times more likely to break. Even though the company was forced to withdraw its products from the market when the discovery was made, thousands of French women are known to still have the defective implants. These implants have never been FDA approved in the US. Only Allergan’s Natrelle and Mentor’s Memory Gel breast implants are currently FDA approved.
The Latest ALCL News
The best information currently available on the topic is a review of opinions by a panel of experts from RAND Health, UCLA’s department of medicine’s division of hematology-oncology, the University of Michigan Health System’s department of surgery’s division of plastic surgery and others. The article has been accepted by ASPS’s Plastic and Reconstructive Surgery Journal, but has not yet been published. The results are based on the small number of cases known to exist, represent the opinions of the seven panel members and are not based on prospective randomized evidence. A copy of the article can be found here. The article’s disclaimer reads: Support for this study was provided by the Plastic Surgery Educational Foundation (PSEF) and the Aesthetic Surgery Education and Research Foundation (ASERF) through unrestricted grants from Allergan, L.L.C.; Mentor Worldwide, L.L.C.; and Sientra, Inc. Neither the study sponsors nor the listed companies had roles in the design and conduct of the study; collection, management, analysis, and interpretation of the data; and preparation, review, or approval of the manuscript.
As more information becomes available, I will post more updates. It is important to remember that this is an extremely rare problem. It is a sensational story though, so it is sure to hit the mainstream media soon. The ASPS, ASAPS and ISAPS are actively seeking all known cases of ALCL found around breast implants to determine what, if any association exists, if there is a causal relationship and how best to treat the disease when discovered. If you have, or know someone who has, ALCL associated with breast implants, please contact one of these plastic surgery societies and the FDA.
More Information About ALCL
A current summery of ALCL cases appeared in the June issue of Plastic and Reconstructive Surgery. The abstract can be read here.
The FDA has an ALCL and breast implants FAQ page here. Moreover, all confirmed cases of ALCL in women with breast implants should be reported to Medwatch, the FDA’s safety information and adverse event reporting program. Report online here or by calling 1-800-332-1088.
How to Detect ALCL Associated with Breast Implants
The chances of getting breast implant associated ALCL are extremely remote. I have thousands of patients with breast implants, and chances are that I will go my entire career without seeing one case. This, however, will not keep me from looking for it.
Most cases of ALCL in patients with breast implants have presented with a seroma (fluid collection) around the breast implant more than six months after the initial surgery. To try and detect ALCL as soon as possible, experts are recommending aspirating (draining) seromas around breast implants when they occur later than six months after breast augmentation or breast augmentation revision surgery, and also sending the fluid for cytologic analysis to check for abnormal cells. If you feel you have a problem with your breast implants, do not delay; seek the advice of a Board Certified Plastic Surgeon in your area.