Memphis, TN. – On March 25-26, 2019, the FDA convened a meeting of the General and Plastic Surgery Devices Panel to discuss BIA-ALCL and Breast Implant Illness. While the conclusions from this meeting have not yet been released, Plastic Surgery Group of Memphis wishes to keep our patients and our community informed on this topic as new information comes to light. The safety of our patients is of the utmost importance to us, and we mean for this release to serve as a point of education on what we know at this time. It will be updated as the FDA releases their findings, and as we in the plastic surgery field learn more.
Patients who have concerns about their implants as it relates to this topic are welcome to discuss this with us in our office at no charge.
BIA-ALCL (Breast Implant-Associated Anaplastic Large Cell Lymphoma) is a spectrum of disease that can range from an accumulation of fluid around the breast (seroma) to a potentially metastatic lymphoma, especially when the diagnosis is delayed. BIA-ALCL is rare and is not a traditional cancer of the breast tissue. When diagnosed early, it is a very treatable disease. The cure rate is high, particularly with implant removal and removal of the capsule around the implant. If the disease is advanced upon diagnosis, chemotherapy or radiation may also be required.
BIA-ALCL is currently classified as lymphoma, but there is research underway to further understand the proper classification of this disorder. In the last 20 years, there have been 17 confirmed deaths globally from this disease or complications associated with it. Nine of those deaths occurred in the US. In the global database of cases, there are 457 unique cases of ALCL in patients with both saline-filled and gel-filled implants of the breast, as well as one patient with gluteal implants. These statistics include women who have had implants placed for both cosmetic and reconstructive purposes.
This disease appears to be related to the texturizing of the outer shell of the implant, and not what the implant itself is filled with. According to the latest global reports, there has not yet been a confirmed case of a patient with ALCL who has had only smooth-shelled implants in their lifetime. Therefore, patients who have had or currently have textured implants appear to be more at risk for developing ALCL than patients who have only had smooth-shelled implants. The FDA reports that the risk of developing ALCL ranges from 1:3817 to 1:30000 women with implants, with the risk being greater in patients who have more highly textured implants. There appear to be geographic distributions and genetic predispositions to developing this condition as well.
At the Plastic Surgery Group of Memphis, we have not had a woman present with signs of ALCL or be diagnosed with ALCL at this time. Reports have shown that previous ALCL patients have presented 2-28 years after their surgery, on average around year eight. Patients should look for late-onset swelling of the breast, not swelling that occurs immediately following surgery. ALCL can also present as a lump in the breast or armpit, firmness of the breast, skin changes, or pain. If you develop any of these symptoms, you should call our office and ask to be evaluated. If you are unsure about the type of implant you have, you can refer to your implant card, or call our office. We can provide you with this information from your medical record.
At this time, we recommend continued close monitoring of your breasts with your annual mammogram, plus additional imaging if any change occurs. While the FDA has previously recommended an MRI to monitor breast implants every 2-3 years, breast ultrasounds are also an excellent way to keep track of any changes. Currently, the FDA and our plastic surgery societies are not recommending prophylactic removal of textured implants. However, we have had some patients elect to do so in light of the information currently available.
We value the safety and satisfaction of our patients and welcome questions or concerns about this topic. We are happy to see patients in our office to discuss what we know about ALCL, and to provide an examination if desired. Please see further information below from the American Society of Aesthetic Plastic Surgeons regarding ALCL.
Plastic Surgery Group of Memphis
Phone: (901) 761-9030
Address: 80 Humphreys Center Drive, Suite 100
Country: United States