title: Incidence of breast implant rupture in a 12-year retrospective cohort: Evidence of quality discrepancy depending on the range.
abstract: OBJECTIVE
  The majority of studies assessing the rupture rate of breast implants were performed by the breast implant manufacturing industry with questionable independence. After repetitive removals of ruptured implants from the same model, our team decided to assess the rupture rate and the estimated risk thereof for most of the silicone gel-filled implants we have used since they regained market approval in France in 2001.
  
  
  METHODS
  Our study is a retrospective cohort of 809 patients operated in our University Hospital from 2001 to 2013 for cosmetic or reconstructive goals. We could track 1561 implants, 90% of them from the same manufacturer, Allergan (Irvine, CA, USA). For each of those, we gathered their exact reference, date of implantation, surgical approach, status, last follow-up visit or the eventual date, and cause of removal.
  
  
  RESULTS
  Of 225 explanted devices, only 27 were ruptured, all from the Allergan brand. Risks of removal for rupture were estimated: 0.5% at 1000 days, 6% at 2000 days, and 14% at 3000 days. Risks were significantly different between the models from this same manufacturer. One of the range of macro-textured round implants showed risks of removal for rupture of 33% at 3000 days compared to 6% for the anatomically shaped range.
  
  
  CONCLUSIONS
  These results suggest a qualitative discrepancy among the different ranges of breast implants of a single manufacturer within the same timeframe of implantation. To determine the in vivo lifespan of the implants that we use more precisely and sooner, we suggest that each removed implant should be analyzed for wear and tear, independently from the industry.
authors.affiliation: Department of Plastic Surgery, University Hospital of Strasbourg, France. Electronic address: frederic.seiglemurandi.hus@gmail.com.
authors.forename: Frédéric
authors.initials: F
authors.lastname: Seigle-Murandi
authors.affiliation: Department of Public Health, University Hospital of Strasbourg, France.
authors.forename: François
authors.initials: F
authors.lastname: Lefebvre
authors.affiliation: Department of Plastic Surgery, University Hospital of Strasbourg, France.
authors.forename: Catherine
authors.initials: C
authors.lastname: Bruant-Rodier
authors.affiliation: Department of Plastic Surgery, University Hospital of Strasbourg, France.
authors.forename: Frédéric
authors.initials: F
authors.lastname: Bodin
mesh_terms: D019928:Breast Implantation; D018427:Breast Implants / Q000009:adverse effects*; D000068598:Data Accuracy; D020878:Device Removal / Q000706:statistics & numerical data*; D005260:Female; D006801:Humans; D015994:Incidence; D011474:Prosthesis Design; D011475:Prosthesis Failure; D012189:Retrospective Studies; D012306:Risk; D020034:Silicone Gels; D013997:Time Factors
chemical_list: D020034:Silicone Gels
keywords: Breast implants; Medical device vigilance; Rupture; Silicone