Risk Factor Analysis for Capsular Contracture, Malposition, and Late Seroma in Subjects Receiving Natrelle 410 Form-Stable Silicone Breast Implants

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We read with interest the article entitled “Risk Factor Analysis for Capsular Contracture, Malposition, and Late Seroma in Subjects Receiving Natrelle 410 Form-Stable Silicone Breast Implants” by Dr. McGuire et al.,1 and commend the authors for their extensive evaluation of this commonly used breast implant. The authors describe four cases of breast implant–associated anaplastic large cell lymphoma (ALCL) in 17,656 patients, after 1 to 10 years. The mean time to review in the four groups was 2.9 to 4.1 years. Patients diagnosed with ALCL were reviewed approximately 3.5 to 11.6 years after implantation. In the overall group, 6 percent of patients were reviewed between 1 and 2 years after surgery. If we assume that similar numbers were seen between years 2 and 3, the overall number of patients at risk of breast implant–associated ALCL (follow-up longer than 3 years) is 15,501. This equates to an overall risk of breast implant–associated ALCL for patients in this study of one case in every 3875 after 3 years (four of 15,501).
It is assumed that recent reports of breast implant–associated ALCL are attributable to better recognition and discussion of this sometimes fatal condition.2 In the decade since de Jong et al. described this condition in a prospective database of patients with breast implants, most consider the overall prevalence to be one in 30,000 cases.3 The largest cumulative retrospective analysis of cases suggests that the majority of cases arise around textured implants.2
Given the current study focused on textured implants, the findings would suggest a far higher prevalence than previously thought, and we feel this merits further investigation and comment by the authors. It is interesting to note that a single case occurred in each of the four patient cohorts of augmentation, revision-augmentation, reconstruction, and revision-reconstruction, respectively. Furthermore, the nature of this study means that the maximum follow-up time was 10 years even though one patient developed breast implant–associated ALCL at 11 years. As recent literature has suggested a median interval of 9.3 years to diagnosis,2 it is therefore likely that the number of cases arising around Natrelle 410 form-stable silicone implants is perhaps even higher than the authors’ reported rate of four in 17,656, as potential cases may not have arisen during the follow-up period within the study.
We agree that the process of recognition and diagnosis of breast implant–associated ALCL continues to evolve among aesthetic and reconstructive breast surgeons,4 and congratulate the authors on their study. However, concern remains that the true prevalence is perhaps higher than previously reported in light of the findings above.

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