Biocell-Initial patents versus user instructions guide: A discrepancy at the core of a crisis

Abstract

Purpose: Our aim is to do a comparative qualitative analysis of patents and "User Manuals" of the Biocell textured implants in order to determine if red flags were omitted when marketing and using Biocell textured implants.

Materials and methods: We performed a systematic qualitative analysis using the NVivo software version 11 of the patents describing the Biocell textured implants prior to their approval by the FDA and of user guides published by the 3 companies owning the patents (McGhan, Inamed, Allergan). To guide our thematic analysis, we used a form of systems theory known as the complexity theory.

Results: Four patents related to Biocell and 2 user manuals (McGhan- Inamed and Allergan) were analyzed. Four themes emerged from the patents: invention description, mechanism of action (Tissue ingrowth), the timing of the mechanism of action and hypothetical actions on capsular contractures prevention. Of all patent's content, 34% described the invention, 29% the mechanism of action (tissue ingrowth), 1% the timing of this mechanism of action and 34% a hypothetical action against capsular contracture. Solid evidence was found on the concept of anchoring and very little on capsular contracture. On the user guide side, the main themes were indications and contraindications, surgical techniques and long-term effects. The "directed" content analysis approach of the user guides regarding the patent's themes reflected that 94% of the user guides content related to the patent thematics was about the hypothetical role on capsular contracture while only 4% was about invention description and 1.5% about tissue ingrowth.

Conclusions: This analysis highlights the discrepancies between patents of Biocell textured implants and user guides for these implants. The indications of use of a treatment or device can evolve quicker than the study of its potential complications and side effects. The BIA-ALCL crisis should serve as a cautionary tale to the plastic surgery community which embraces new technologies eagerly, and sometimes precariously, in a mission to advance patient care.

Keywords: Anaplastic large cell lymphoma; Breast implants; Breast reconstruction; Implants mammaires; Implants texturés; Lymphome anaplasique à grandes cellules; Reconstruction mammaire; Textured implants.