Update: Implants and ALCL
- Posted on: Mar 22 2017
Many of you may have seen the NYT article published today regarding implants and risk for a rare type of cancer, Anaplastic Large Cell Lymphoma (ALCL). In light of the concern this may cause many of our patients, we wanted to offer some clarifying additional information on the ALCL and breast implant issue.
History of ALCL and Breast Implants
In 2011, the FDA identified a possible connection between breast implants and the development of ALCL, a rare type of non-Hodgkins Lymphoma. This disease is noted in the general population, but was found to be somewhat more prevalent in women with breast implants. At that time, data was quite scarce as there were so few cases (34 documented cases in an estimated 5-10 million women with breast implants). Additionally, the specific factors that increased risk could not be identified.
Due to concern, however, the scientific community began a more in depth investigation of the disease itself and the patients it was affecting. As a result of those efforts, breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) has been differentiated from ALCL as a rare form of T-cell lymphoma that can develop following the placement of breast implants. Data collection has still been limited but has led to some increased knowledge of the disease, how it presents, and the settings within which it is more commonly seen.
As of February 1, 2017, the FDA has received a total of 359 medical device reports of BIA-ALCL. Of these, 231 reports included information about the implant surface, 203 of which were textured implants. Most reports contained no information about the surface of any previous implants. Of the reported implants, 186 were filled with gel and 126 were saline. Patients who had confirmed BIA-ALCL often presented with late onset persistent fluid collection around the implant. Some patients were also found to have capsular contracture, or a mass adjacent to the breast implant.
Since 2011, a significant body of medical literature has been published about BIA-ALCL. Factors that may influence its development, including the methods used to create surface texture of the implant and the role of biofilm in causing disease have been reviewed. All of the data thus far suggests that women with implants have a small but measurable increased risk of developing BIA-ALCL compared with women who do not have implants. Most cases are treated by removal of the implant and the surrounding capsule. Very rarely, patients have been treated with chemotherapy and radiation.
Implants at NSPS
We at Northwestern Specialists in Plastic Surgery (NSPS) are dedicated to the education and safety of our patients and want our patients to take on this important topic. We also want to ease anxiety about this important issue by pointing out that it is not our normal practice to place textured permanent implants. In fact, I gave a presentation about why I choose smooth implants recently at the annual meeting of plastic surgeons. I noted the concern for new findings regarding BIA-ALCL as one of my important considerations.
Many of our reconstruction patients may have had textured tissue expanders in place temporarily during their reconstruction process. As stated above, most reported cases were patients with textured implants in at the time of diagnosis with abnormal physical exam findings; history of textured implants was often not recorded and, therefore, there is limited information to suggest if having a history of textured implants contributes to risk for BIA-ALCL. As we navigate this issue, we feel limited exposure to a textured tissue expander for 3-6 months is unlikely to contribute to the subsequent development of BIA-ALCL many years later. We do, however, feel it is best practice to avoid textured permanent implants, which patients will have in place for many years or even decades.
What does this mean for you?
As a result of this recent update, we are not recommending any change to the way we monitor our patients with implants. Similar to our longstanding recommendation for monitoring, we recommend having breast awareness. If you notice a lump or bump that is growing, or if you develop a change in the way the breast looks or feels (such as a change in the color or texture of the skin or swelling of the breast itself), we recommend you follow up with us for exam. Remember, although identified as a potential risk, the risk for developing BIA-ALCL is extremely low.
As more information is becoming available, we do, however, anticipate that our patient education will also grow. We have updated our website with additional information here. If you’d like additional information, you can also read the FDA’s initial review or their updated review. And, of course, if you feel you have additional questions or concerns and would like to get direct feedback from us, please feel free to reach out to us anytime. We take caring for you seriously, we take this information seriously, and we are here to help you navigate this issue.
Want to know more? Link to our webpage for additional information.
Tagged with: Neil Fine MD
Posted in: Uncategorized