Not All Breast Implants are Equal: A 13-Year Review of Implant Longevity and Reasons for Explantation.

Breast implants are currently available in a variety of shapes, sizes, volumes, surface textures, filler materials, and contours. Numerous companies, all of whom have subtle trade secrets related to the manufacturing of breast implants, are in the business of marketing these devices.

Each will attest to their implant being better than the competitions implant based on different manufacturing strategies and clinical outcome studies. Of the many manufacturing differences, variations in surface texturing and gel cohesivity are two prominent areas of divergence.

Thus, it is evident that all breast implants are not created equally; however, the question remains as to whether or not all implants perform equally.
In a recent publication from Plastic and Reconstructive Surgery entitled, Not all breast implants are equal: a 13-year review of implant longevity and reasons for explantation, Van Slyke et al retrospectively reviewed their experience with 248 patients that had 552 explantations following breast augmentation.

The purpose of the manuscript was to determine if one named implant (Allergan Biocell device, Irvine, CA, USA) performed differently when compared to a cluster of other implants (manufacturers not listed).

The authors assessed “performance failure” based on 8 random parameters that included malposition, malrotation, seroma, rippling, Baker grade III/IV capsular contracture, rupture, pain, double capsule and any other abnormal intraoperative finding. The authors concluded that Biocell implants had the highest rate of performance failure (85.4%) followed by other textured gel (75%), saline (57.5%) and smooth gel (50.3%).

My response to the manuscript was critical based on its methodology, use of a non-validated measurement tool (“performance failure”), and an arbitrary classification system. Of the 123 Biocell devices, 105 were categorized as exhibiting “performance failure” that was calculated at a rate of 85.4%. Interestingly, of these 105 devices exhibiting “performance failure”, 45 were associated with double capsules at the time of explantation.

It is important to appreciate that double capsules are completely asymptomatic, incidental findings at time of reoperation and most often associated with macro surface textured devices such as Biocell. They do not constitute a reason for explantation.

Based on the “performance failure” rate of 85.4%, the authors opined that Biocell devices were more prone to rupture, pain, and performance failure compared to all other implants in the setting of aesthetic breast augmentation.

The reason for my response was that I had been using Biocell implants for several years and my experience was completely different than what these authors had reported. It seemed that there was an inherent bias against these devices based on the parameters studied. I therefore decided to recalculate “performance failure” by omitting double capsules from the analysis because double capsules do not constitute performance failure.

By subtracting 45 (the number of double capsules) from 105 (the number of performance failures), the recalculated Biocell “performance failure” would drop to 48.8%. Ironically, this value results in Biocell having the best rating and therefore exhibit the lowest “performance failure” rate. Clearly, this arbitrary system for “performance failure” is biased and because it is not validated, the results are misrepresentative. What was noteworthy from the manuscript was that of the 123 Biocell devices with 7 late seromas; there were no cases of ALCL.

In summary, plastic surgeons would generally agree that the perfect breast implant does not exist. No implantable device will last forever. Over time, the risk of capsular contracture, rupture, pain, and malposition may lead to explantation regardless of the device used. Plastic surgeons should be cognizant of these facts and not persecute devices based on incidental findings that do not contribute to explantation.

References
1. Van Slyke AC, Carr M, Carr N. Not all breast implants are equal: A 13-year review of implant longevity and reasons for explantation. Plast. Reconstr. Surg. Epub ahead of print. June 4, 2018.

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Maurice Y. Nahabedian MD, FACS

Plastic Surgeon at National Center for Plastic Surgery.