title: Poly implant prothèse asymmetrical anatomical breast implants: a product recall study.
abstract: BACKGROUND
  In 2010 high rupture rates were unexpectedly found among prostheses produced by the French manufacturer Poly Implant Prothèse. Since then, several studies have been performed concerning the round implants, but there are still few data available on anatomical implants.
  
  
  METHODS
  From 2003 to 2006 Poly Implant Prothèse implants were employed at the authors' institute for immediate or delayed reconstruction after mastectomy. All implants were anatomical and asymmetrical. In November of 2010, the authors began offering free consultation with a plastic surgeon and radiologist. Demographic data, type of reconstruction, implant lifespan, indications for implant removal, and rupture rate were recorded.
  
  
  RESULTS
  A total of 578 women underwent postmastectomy immediate or delayed reconstruction with 658 Poly Implant Prothèse implants from 2003 to 2006 at the authors' institute. The authors explanted 409 of 443 prostheses, and 34 were explanted at other centers. Eighty-nine patients died and 120 are alive with the implants in place. The mean implant lifespan was 57.5 months, 76 ruptured implants were explanted (18.5 percent), and in 22 cases (5.4 percent), leakage of silicone gel was detected.
  
  
  CONCLUSIONS
  Poly Implant Prothèse implant failure is to be ascribed to shell structure, although the primary safety issue concerned the gel (an industrial-grade and low-cohesive silicone). These issues produce the known rupture rates in the manufacturer's round implants. The authors' use of only anatomical and asymmetrical implants, with their more cohesive silicone gel and more rigid shell allowing a stable form and projection along with a natural feel and touch, probably reduces the rupture rate and silicone spread, although these events remain unacceptably high compared with similar products of other brands.
  
  
  METHODS
  Therapeutic, IV.
authors.affiliation: Milan, Italy From the Departments of Plastic and Reconstructive Surgery and Breast Surgery, European Institute of Oncology.
authors.forename: Francesca
authors.initials: F
authors.lastname: De Lorenzi
authors.forename: Riccardo
authors.initials: R
authors.lastname: Gazzola
authors.forename: Claudia
authors.initials: C
authors.lastname: Sangalli
authors.forename: Oriana
authors.initials: O
authors.lastname: Villa
authors.forename: Miriam
authors.initials: M
authors.lastname: Marchetti
authors.forename: Massimo
authors.initials: M
authors.lastname: Monturano
authors.forename: Jean Yves
authors.initials: JY
authors.lastname: Petit
authors.forename: Cristina
authors.initials: C
authors.lastname: Garusi
authors.forename: Stefano
authors.initials: S
authors.lastname: Martella
authors.forename: Andrea
authors.initials: A
authors.lastname: Manconi
authors.forename: Benedetta
authors.initials: B
authors.lastname: Barbieri
authors.forename: Alessandra
authors.initials: A
authors.lastname: Gottardi
authors.forename: Marco
authors.initials: M
authors.lastname: Iera
authors.forename: Marco Aurelio
authors.initials: MA
authors.lastname: da Costa Silva
authors.forename: Paolo
authors.initials: P
authors.lastname: Veronesi
authors.forename: Mario
authors.initials: M
authors.lastname: Rietjens
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D018427:Breast Implants; D015331:Cohort Studies; D005260:Female; D006801:Humans; D057052:Medical Device Recalls; D008875:Middle Aged; D011474:Prosthesis Design; D011475:Prosthesis Failure; D012189:Retrospective Studies; D020034:Silicone Gels; D055815:Young Adult
chemical_list: D020034:Silicone Gels