Commentary on: The Influence of BIA-ALCL on the Use of Textured Breast Implant and its Placement: A Survey of Dutch Plastic Surgeons

See the Original Article here.

Bletsis et al’s article “The Influence of BIA-ALCL on the Use of Textured Breast Implant and its Placement: A Survey of Dutch Plastic Surgeons” aims to provide an instant picture of breast implant use among Dutch plastic surgeons and the influence breast implant–associated anaplastic large cell lymphoma (BIA-ALCL) has on this.¹ The authors designed a simple but efficient study in a country in which BIA-ALCL awareness is very high.² In fact, the Netherlands is one of the few European countries with an active opt-out breast implant registry,³ and many articles with solid epidemiologic data on BIA-ALCL in the Netherlands have been published.⁴ A survey's validity depends on both response rate and sample size, and a high rate (>80%) from a small, random sample is preferable to a low response rate from a large sample.⁵ Although this survey is limited by a low response rate of 21% from a small sample (ie, the Netherlands plastic surgeon population), important conclusions regarding trends at European level can be drawn. Bletsis et al’s statement that BIA-ALCL has had a significant impact on the use of macrotextured breast implants in the Netherlands in both reconstructive and aesthetic breast surgery is important: they are reporting an issue that has been predicted but not yet demonstrated, and they prove that the protection of European citizens’ health enacted by the European Commission on Health through its independent Scientific Committee on Health, Environmental, and Emerging Risks (SCHEER) was worthwhile. Based on a statistical analysis of the literature for 2021, SCHEER first demonstrated a causal relationship between textured breast implant use and BIA-ALCL, and then determined that texturization was the principal risk factor and the best way to reduce the occurrence of BIA-ALCL was to limit the use of macrotextured implants. Following such a statement, a smart market is likely to react to the risk of BIA-ALCL by shifting towards safer micro/smooth surfaces, and I am quite sure this trend could be even more pronounced among younger colleagues. Although this new knowledge may well promote a swift shift of colleagues towards implants with safer surfaces to preserve the health of their patients and practices, it is even more important for the medical industry and health authorities. The former, equipped with advanced knowledge of market preferences, can be expected to act promptly by redirecting their implant production to micro and smooth surfaces; while the latter may consider, when planning their strategies, that by, say, 10 years from now the occurrence of BIA-ALCL will have faded and more financial resources will be available for a reasonable prophylactic explantation campaign based on risk stratification of patients bearing textured implants. The authors address this important issue with a statement from the Dutch health authorities: “Even though most cases of BIA-ALCL in the Netherlands concern macrotextured Biocell breast implants, patients are not recommended to have them preventively explanted as the risks of developing lymphoma are small and are outweighed by the risk of regular surgical complications.” Unfortunately, no link to the full document and the date of issue is provided; recent literature has demonstrated that the risk of BIA-ALCL has increased substantially, whereas explantation surgery has zero reported mortality and risks of complication comparable to those of any other explant or capsulectomy performed for other indications such as implant rupture or capsular contracture.⁶ Another very important piece of information provided by this review is that surgeons did not change their surgical technique when switching from macrotextured to smooth surface implants, meaning that the choice of the technique is independent of the transition to new devices, and thus does not require a demanding learning curve. Nevertheless, the gel in smooth implants is less cohesive and softer, potentially allowing for an easier prepectoral positioning without the unpleasant effect of superior ridge show typical of anatomic textured implants, which have a stiffer gel filler. Based on our personal experience with using exclusively smooth implants since 2016, we have increasingly switched to the prepectoral plane and have achieved consistent aesthetic outcomes after acquiring more confidence with smooth devices. The authors sometimes get sidetracked by stating that texturing was introduced to reduce capsular contracture rates, although the main reason for a textured surface is to avoid rotation of anatomic implants.⁷ Capsular contracture is also erroneously attributed to smooth implants, but only when studies with first-generation smooth implants that presented significant silicone leakage are considered.⁸ New-generation smooth implants (according to the ISO classification) are not associated with higher capsular contracture rates in both animal and clinical studies.^9,10 Moreover, the narrative regarding biofilm formation, bacterial contamination, and BIA-ALCL, although it represents one of the discussed etiologic mechanisms, has never been validated as a potential stimulus.¹¹

Therefore, any measures to eliminate biofilm and BIA-ALCL are based purely on theoretical and unconfirmed studies that only aim to minimize BIA-ALCL.¹² BIA-ALCL is considered an uncommon pathology with a possible multifactorial etiology (genetic predisposition, bacterial contamination, shell shedding of particulates, shell surface characteristics, exposure to implant-associated reactive compounds) and a pathology where chronically stimulated T cells would be assumed to acquire malignancy-promoting mutations.¹³

It would have been interesting to ask Dutch surgeons regarding rates of implant replacement requests from patients aware of BIA-ALCL and the link with textured surfaces. Recent literature reviews offer insight regarding stratification of patients at risk and the consideration of prophylactic replacement/explantation.¹⁴ The main concluding message is the importance of promoting awareness of BIA-ALCL among scientists and patients, and how scientific research is the only way to obtain definitive answers.¹⁵

Disclosures

Dr Santanelli di Pompeo reports that the NESMOS Department with which he is affiliated has received research funds from Motiva, Establishment Labs (Alajuela, Costa Rica) in 2017, and from GC Aesthetics (Dublin, Ireland) in 2018 and 2020. The NESMOS Department has also received mini-implants from Establishment Labs, GC Aesthetics, and Sebbin (Boissy-l’Aillerie, France) for research purposes. Dr Santanelli di Pompeo is a paid consultant for BellaSeno GmbH (Leipzig, Germany); has received reimbursements for travel/lodging expenses from ICEAG in 2015 and SCHEER-WG in 2019, 2020, and 2021; and is a member of Notified Body 0373, part of the Superior Institute of Health, which carried out CE mark certification activities for the Italian Ministry of Health for the year 2021. In December 2022, Dr Santanelli di Pompeo received from Establishment Labs a speaker fee of US$1000. Dr Santanelli di Pompeo has no ownerships or investments to disclose and has no financial interest in any of the products, devices, or drugs mentioned in this manuscript.

Funding

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

REFERENCES

Author notes