In 2011, the FDA announced a POSSIBLE association between textured implants and a lymphoma called Anaplastic Large Cell Lymphoma (ALCL). By 2016, a DEFINITE association was established and became widely known. There has never been a confirmed case of BIA-ALCL associated with only smooth implants. Patients with smooth implants who developed BIA-ALCL were all found to have been exposed to textured implants at some point in their prior implant history. Originally, the incidence of the lymphoma was estimated to be only one in 1 million (1:1,000,000). Unfortunately, the incidence has since been estimated to be much higher. For example, the incidence of BIA-ALCL is reported to be as high as 1:16,700 for those with micro-textured Siltex implants manufactured by Mentor. Much worse, the macro-textured implants from Allergan (Biocell) have since been found to have an incidence of BIA-ALCL of 1 in 400, prompting the voluntary recall of Biocell implants from the market in July 2019. Doctor Peter Cordeiro at Sloan Kettering in New York did all of his breast reconstructions with textured Allergan implants and found that the incidence of BIA-ALCL amongst his patients may be as high as one in 100. Unfortunately, as time passes and more cases of BIA-ALCL are being diagnosed, the incidence appears to be even higher.
The normal reaction of the human body to any foreign object (including breast implants) is to form a capsule around that object. That is completely normal for the human body. With textured implants, the rough surface between the implant and the capsule is thought to create a chronic and constant inflammatory response, which may ultimately lead to BIA-ALCL. The classic presentation of BIA-ALCL is the development of fluid around the implant–capsule, formation of a mass, deep itching over the implant, swelling of adjacent lymph nodes or contracture (hardening of the capsule around the implant), typically about 7-8 years after breast augmentation. Unfortunately, a small percentage of patients with BIA-ALCL will not develop any of these signs, leading to delayed diagnosis and treatment. Current guidelines recommend biopsy of the mass or collection of the fluid to rule out BIA-ALCL, using the CD 30 marker. The treatment for CONFIRMED BIA-ALCL includes capsulectomy-en-bloc, an oncologic term which implies the removal of the implant, its capsule as well as a cuff of normal surrounding tissue.
The American-Canadian recommendation for patients with textured implants BUT NO DIAGNOSIS OR STRONG SUSPICION OF BIA-ALCL dates from 2016 and is to simply follow these patients and biopsy if a suspicious fluid collection or mass develops. Understandably, patients with textured Allergan implants find that recommendation difficult to accept. These patients are often heard saying “I feel like I have a bomb in my chest, waiting to explode”. However, a very recent study by Di Pompeo et al suggests that capsulectomy for textured implants may reduce the risk of developing BIA-ALCL.
Dr. Nicolaidis: “It’s one thing to follow patients with a 1 in 17,000 risk of lymphoma for the signs of BIA-ALCL. But for patients with a risk of 1 in 400, I cannot in good conscience simply tell them to watch for the signs of BIA-ALCL… because that’s NOT what I would do if a loved one had Biocell implants. In difficult situations such as this, doctors should not play God and simply tell patients what to do. Rather, patients must be told and understand the FACTS in order to make an informed decision themselves.”
So here are the facts. These recommendations to follow patients with textured implants for the signs of BIA-ALCL come primarily from MD Anderson in Texas, where they have been collecting all the cases of BIA-ALCL. And the basis for the recommendations are the following:
1) BIA-ALCL is still not well understood.
2) There has been at least one case of BIA-ALCL developing in a patient who supposedly had a prophylactic capsulectomy. The problem is that it is not certain that the capsule was completely removed.
3) Acceleration of BIA-ALCL has been seen following capsular biopsy.
4) Risks of capsulectomy are significant.
Dr. Nicolaidis disagrees with the 4th point; Plastic Surgeons experienced in explant surgery do NOT find the risks to be significant (discussed later). Once again, patients must be told and understand the risks of capsulectomy in order to make an informed decision themselves.