Commentary on: The Macrotextured Implant Recall: Breast Implant–Associated Anaplastic Large Cell Lymphoma Risk Aversion in Cosmetic and Reconstructive Plastic Surgery Practices

See the Original Article here.

In response to a growing realization that the incidence of breast implant–associated anaplastic large cell lymphoma (BIA-ALCL) was increasing, the Penn State group stopped using any textured breast implants and embarked on a process to identify and notify our patients. The results of this process were published in 2019.¹ The duty to inform patients who already have these implants is now generally accepted.

This report by Mankowski et al provides important insights into how patients will react to new information they receive about BIA-ALCL.² The study group was made up of patients with macrotextured implants who were followed up with in-person clinic visits. We do not know how many patients were contacted, but as the authors point out, patients sufficiently concerned to have an in-person clinic visit are more likely to have surgery. Almost 50% of the cosmetic patients and 60% of the reconstructive patients scheduled implant removal or exchange. That more reconstructive patients who have had to deal with breast cancer elected to have surgery is not surprising. It was interesting to see that although fear of BIA-ALCL was the prime concern of the cosmetic patients, additional motivating factors included pain and cosmetic concerns. A higher percentage of the cosmetic patients have in fact elected to or have undergone additional cosmetic procedures at the time of implant exchange. The authors also reported on the longer time to treatment for the reconstructive patients. Multiple factors such as a mix of self-pay, government insurance, and operating room availability explain this observation. There will be some local variation, but this is likely true in other parts of the world.

Surgery is not currently recommended for nonsymptomatic patients with any textured implants,³ but is this really the best advice for patients with macrotextured implants? The fact that 3 of the 123 cosmetic patients who have so far undergone surgery in this cohort were diagnosed with BIA-ALCL is striking. This study only addresses what motivates patients to have surgery, but this finding is further evidence that we are almost certainly underestimating the true incidence of BIA-ALCL.

Cordeiro et al published data on a large cohort of patients with textured implants, indicating rates as high as 1:355.⁴ Uniquely this is a single surgeon’s experience. Dr Cordeiro’s practice is also unusual in that he has documented yearly follow-up on each of his patients, a practice that very few of us can replicate. Australia and the Netherlands report the highest prevalence rates (1:2976 and 1:2696, respectively).⁵ Both counties have opt-out breast implant registries and thereby provide the most accurate data for large populations. Making the correct diagnosis of BIA-ALCL requires a high index of suspicion and sophisticated laboratory resources. It is likely that many of these cases are misdiagnosed as either recurrent or primary breast cancers, a warning previously published in this journal.⁶ One fact is clear: the harder we look, the more cases we find.

Press surrounding the calls for banning and recalls of Allergan’s macrotextured implants together with warnings required for operative consents and warning letters to existing patients have all heightened patient awareness of BIA-ALCL. However, as the authors point out, the information patients receive is inconsistent. It is certainly going to be influenced by their surgeon’s personal view of the risk. Unfortunately, many of our colleagues still downplay this risk and denigrate fellow colleagues who report otherwise.⁷ One thing we have not done well is to update our patients as we learn about the increased risk they face. I am sure that Dr Cordeiro’s patients are more likely to request implant removal with a complete capsulectomy than patients at most other practices. I wonder how the cohort of patients presented here would react to the news that so far 3 asymptomatic patients have been diagnosed with ALCL?

The authors have made the ethical recommendation that we have a duty to report everything we know in an open and transparent fashion that helps our patients make their treatment decisions. They framed this as a need to avoid unnecessary treatment. Perhaps we ought to be thinking more about preventing BIA-ALCL.

Disclosures

The author declared no potential conflicts of interest with respect to the research, authorship, and publication of this article.

Funding

The author received no financial support for the research, authorship, and publication of this article.

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