Allergan Announces BIOCELL(R) Replacement Warranty
A disease called Aplastic Large Cell Lymphoma (ALCL) has recently been widely reported in the press. My office has received many calls from patients with concerns for their health and I wanted to post an update from Allergan (Inamed/McGhan), one of the major implant manufacturers, and the one I use most frequently.
First, I want to put things into perspective. ALCL was first reported approximately 6 years or so ago. It is an uncommon cancer that involves the lymph system. The cancer is NOT breast cancer. It occurs in the scar tissue capsule that surrounds every implant. ALCL has been reported in both smooth and textured surface implants as well as silicone gel and implants. Interestingly, ALCL has also been found in the scar tissue of other implantable devices such as cardiac pacemakers!
ALCL is much frequent in textured implants and for this reason, textured implants were removed from the market in Europe. As of July, 2019, Allergan followed suit and removed all textured implants from the market. The attached update explains their policy for replacement along with some FAQ's.
The number of reported ALCL cases is increasing slowly. As of January 2019, the number of cases was in the range of 600 or so. To put this into perspective, there are literally millions of breast implants in women throughout the world, and the FDA still considers them to be safe and effective. It is important to understand that with this low number of reported cases, we as doctors and scientists cannot make any inferences regarding causation. What that means is that we don't know if the implants cause ALCL or they are related to the development of ALCL in some small percentage of people. With such a small number of ALCL patients compared to the large number of people with implants, it is very unlikely that you will get the disease. Fortunately ALCL is very curable if caught early.
ALCL has been reported to occur between about 7 to 9 years after implantation. The disease presents as a swelling of the breast with hardening. Pain may or may not be present and lymph nodes under the arm or neck or perhaps elsewhere may be enlarged. Enlarged lymph nodes are usually firm and not painful.
Work up/evaluation for ALCL involves radiographic studies as indicated to diagnose fluid (ultrasound for example) followed by obtaining a fluid sample which is evaluated by a pathology lab. If positive, further workup may include CT scans, X-rays, and routing testing Treatment includes implant and scar tissue removal at the minimum. Additional treatment would vary with each individual case.
Here is the bottom line. Your individual risk for contracting ALCL is very low, and the disease is very curable if caught early, even if you have textured implants. Despite this, it is important to monitor your health with monthly breast self-exams (BSE), annual visits to your gynecologist, and your plastic surgeon. It is important that you remain vigilant and if anything changes or you have any questions or concerns, contact your plastic surgeon. Remember, you plastic surgeon is your partner and is here to help.