Natrelle Biocell implants (Allergan) have the shortest time-to-explantation and the highest proportion of implants associated with implant performance failure, according to a study of breast implant explanation at an aesthetic practice between January 2005 and 2017.
The retrospective review, which appears in the journal Plastic and Reconstructive Surgery, consists of 539 breast implants that were explanted during the study period: 249 saline, 147 smooth gel, 123 Biocell and 20 other nonaggressively textured breast implants.
The average time from placement to explantation for the Biocell implants was 4 years compared to 7.5 years for saline, 5.6 years for other textured implants and 4.9 years for smooth gel.
The study also found that the percentage of implants removed due to implant performance failure was 85.4% for Biocell implants versus 75% for other textured, 57.5% for saline and 50.3% for smooth gel.
“Biocell implants may present for explantation due to pain, which represents an unusual subset of failed implants not previously described in the literature,” says principal investigator Nicholas Carr, M.D., FRCSCS, clinical professor of dermatology at the University of British Columbia (UBC) in Vancouver, Canada. “Intraoperatively, our findings strengthen the previous association between Biocell implants and double capsules and late seromas.”
Perhaps what was most surprising about the study was this link between Biocell implants and pain, Dr. Carr tells The Aesthetic Channel. “The pain that we are seeing with Biocell implants is an unusual presentation, which we suspect is related to failed tissue adherence with the implant itself,” he says. “We think that due to shearing forces, the implant starts to tear away the zones of adherence, creating pain as the layers separate.”
First author Aaron Van Slyke, M.D., a senior resident in plastic surgery at UBC, tells The Aesthetic Channel that he and Dr. Carr believe that what they have demonstrated “…is just the tip of the iceberg when it comes to the problems seen with Biocell implants. While it is still unclear what the etiology is behind many of these findings, we propose that the array of problematic clinical presentations and intraoperative findings discussed here are likely to arise from failed tissue adherence and when present, may perpetuate a chronic inflammatory state.”
In the genetically predisposed patient, “it is possible that these clinical and intraoperative findings could lead to the development of breast implant associated-anaplastic large cell lymphoma (BIA-ALC),” Dr. Van Slyke says. “But further studies are needed to confirm this.”