Joint ASPS and ASAPS Advisory to Members on FDA's Update regarding Breast Implant-Associated ALCL
The American Society of Plastic Surgeons (ASPS) and The American Society for Aesthetic Plastic Surgery (ASAPS) would like to make their members aware of a recently issued FDA update regarding breast implants and anaplastic large cell lymphoma (ALCL), or breast implant-associated anaplastic large cell lymphoma, (BI-ALCL).
In 2011, the FDA reported a detailed analysis of 34 cases. The recent FDA update summarizes the data reported to the MAUDE database, which as of September 10, 2015, now represents 258 medical device reports (MDR)s. Based upon this, the FDA estimates total number of US cases of breast implant associated ALCL to be between 100 and 250 cases. The FDA confirms women with breast implants do not need to change their routine medical care and follow up. The FDA specifically recommends reporting all confirmed cases of ALCL and breast implants to both the FDA and the PROFILE Registry.
Where did this new information come from?
The new data appearing on the FDA website is a literature review of current BI-ALCL findings. You can find the relevant clinical information from Plastic and Reconstructive Surgery, the Journal of Clinical Oncology and JAMA.
Does ASPS or ASAPS believe there's a safety risk to women with implants?
No. BI-ALCL is an extremely rare and highly treatable type of lymphoma that can develop around breast implants. BI-ALCL is not a cancer of the breast tissue. Because BI-ALCL is so rare, there is limited data from clinical reports and more information is needed to fully understand the possible association between breast implants and ALCL.
What data is available?
According to the most recent data available, the risk of association between breast implants and ALCL is extremely low. A March 2015 study published in the journal Plastic and Reconstructive Surgery identified 173 individual patients presenting, via a world literature review, with ALCL since the issue was first reported in 1997.
Available data shows that most patients who do develop BI-ALCL have an excellent prognosis following surgical removal of the breast implants and the surrounding scar tissue capsule.
If you have a patient diagnosed with ALCL, it is important to submit case information to the PROFILE Registry
The PROFILE Registry is for the purpose of centralizing and standardizing all reports of BI-ALCL to help determine if an association exists between ALCL and women with breast implants as well as for identifying potential risk factors and disease management practices. To begin submitting case information visit www.thepsf.org/PROFILE.
For Your Patients
- Please encourage patients to follow their normal routine in medical care and follow-up.
- Ask patients to contact you if they notice pain, lumps, swelling, fluid collections or unexpected changes in breast shape, including asymmetry.
- Abnormal screening results or implant-related symptoms may result in additional testing to properly diagnose any abnormalities associated with your patient's implants. Tests and procedures could include but may not be limited to: obtaining breast seroma fluid or tissue for pathology and laboratory evaluation and surgery to remove the scar capsule around the breast implant, implant removal or implant replacement.
- In most cases, women observed changes in the look or feel of the area surrounding the implant after their initial surgical sites were fully healed.
- Considering the millions of women throughout the world with breast implants, the numbers of patients affected are very small, but continue to be investigated, collected, and confirmed. A pattern of presentation includes fluid accumulation around the implant, scar capsular contracture, and capsular mass or lymph node swelling in the armpit. Continued follow-up after any breast implant surgery is suggested and important for patient health.
- Women considering implants deserve choices and need the best information we can give them to see if they're right for them. Patients undergoing plastic surgery procedures, aesthetic or reconstructive, should be thoroughly informed of the potential risks and possible complications known to be associated with the procedure, and any device used in that procedure.
- In the extremely rare case where a diagnosis of ALCL is made, the treatment is removal of the capsule as completely as possible. ASPS and ASAPS are committed to patient safety, advancing quality of care, and practicing medicine based upon the best available scientific evidence. We will continue to monitor and review all new information as it becomes available to keep the plastic surgery community informed.
Important FDA articles regarding ALCL:
Anaplastic Large Cell Lymphoma (ALCL) »
Medical Device Reports of Breast Implants in Women with ALCL »