ASPS Response to AAPS Recommendation Regarding Textured Implant Removal
Promoting the highest quality of care among plastic surgeons and enhancing patient safety are paramount to the missions of the American Society of Plastic Surgeons (ASPS) and The Plastic Surgery Foundation (PSF). Keeping plastic surgeons and patients informed of new information is vital to ensuring they remain educated and empowered in shared healthcare decision-making.
Through its scientific journal, Plastic and Reconstructive Surgery, ASPS publishes studies that contribute to the overall body of knowledge in the specialty and may spark further discussion to expand on existing research.
Recently, Plastic and Reconstructive Surgery published the article "Breast Implant-Associated Anaplastic Large Cell Lymphoma: Evidence-Based Consensus Conference Statement from the American Association of Plastic Surgeons." Among the recommendations in this article, Recommendation 8 sets forth several conclusions and observations based on a systematic review of 248 published BIA-ALCL cases. The authors conclude that "prophylactic explantation of macrotextured surface implants may be considered reasonable" based on the potential for risk reduction and "explantation of any textured implants" may be reasonable when coupled with a broader surveillance and care plan.
Anticipating plastic surgeons and patients may have questions about how this recommendation impacts their care, ASPS staff and an independent, external methodologist reviewed the original publication, which forms the basis for the authors' risk reduction rationale (i.e., Di Pompeo et al., 2023 https://doi.org/10.1093/asj/sjac312) along with a published commentary on the article (i.e., Clemens, 2023 https://doi.org/10.1093/asj/sjad004) to better understand these conclusions.
After conducting this review, ASPS believes some additional context is important to share with all stakeholders. In the underlying systematic review, there was no randomization and no control or comparison group (i.e., controls without BIA-ALCL). The time to BIA-ALCL development was indeed longer in those women who had one or more implant replacements, but all 248 included patients developed BIA-ALCL. Therefore, the risk of developing BIA-ALCL does not appear to have been reduced based on this study group alone. The Society believes that to demonstrate a risk reduction or protective effect, the analysis would need to include controls with or without BIA-ALCL to provide either a risk ratio or odds ratio.
While the Society's interpretation is that the evidence cited in the consensus statement does not indicate that the risk of BIA-ALCL is reduced by prophylactic explantation, the Society and authors do appear to agree that it is nevertheless a complex individual decision. The consensus statement authors note that prophylactic explantation is not equally advisable for all patients. Women are encouraged to partner closely with their board-certified plastic surgeon to create a personalized risk-benefit analysis that takes into account personal goals and risk tolerance, current health status, risks associated with different textured implants and an individual surgical risk assessment.
Based on the available evidence, ASPS recommends following current FDA guidance, which does not recommend the removal of breast implants for asymptomatic women. However, ASPS supports patient choice and the shared decision-making process: a woman who desires to have her breast implants removed – for any reason – is encouraged to consult her plastic surgeon.
Additional information: CDRH Statement from the FDA
Published: 02/28/2024