title: The impact of poly implant prothèse fraud on breast cancer patients: a report by the institut curie.
abstract: In March of 2010, French authorities suspended the use of breast implants made by the company Poly Implant Prothèse. Institut Curie is a large cancer center, and Poly Implant Prothèse was one major silicone-filled breast implant brand used. This report describes the impact of the fraudulent implants worldwide and more specifically on patient care at the authors' unit. From 2002 to 2009, the median number of Poly Implant Prothèse implants removed per year was 32. Since the first alert in March of 2010, 252 of these breast implants were removed in 2010 and 2011. The breast implants removed were mainly reported as normal, with a rupture rate of less than 5 percent before 2008. However, the annual rupture rate has increased from 2008 to 2011 (8, 14, 20, and 23 percent, respectively). The Institut Curie, in conjunction with breast cancer patients, has organized a management plan to deal with this major industrial fraud. Its surveillance program of breast cancer patients facilitated the management of patients during this difficult time.
authors.affiliation: Paris, France From the Institut Curie.
authors.forename: Fabien
authors.initials: F
authors.lastname: Reyal
authors.forename: Jean-Guillaume
authors.initials: JG
authors.lastname: Feron
authors.forename: Solene
authors.initials: S
authors.lastname: Leman Detour
authors.forename: Anne Gaelle
authors.initials: AG
authors.lastname: Pourcelot
authors.forename: Morgane
authors.initials: M
authors.lastname: Valentin
authors.forename: Anne-Cecile
authors.initials: AC
authors.lastname: Phillippe
authors.forename: Yaelle
authors.initials: Y
authors.lastname: Levy-Zauberman
authors.forename: Antoine
authors.initials: A
authors.lastname: Agman
authors.forename: Sindy
authors.initials: S
authors.lastname: Monier
authors.forename: Anne
authors.initials: A
authors.lastname: Blondel
authors.forename: Isabelle
authors.initials: I
authors.lastname: Cothier-Savey
authors.forename: Thierry
authors.initials: T
authors.lastname: Guihard
authors.forename: Perig
authors.initials: P
authors.lastname: Le Masurier
authors.forename: Alfred
authors.initials: A
authors.lastname: Fitoussi
authors.forename: Benoit
authors.initials: B
authors.lastname: Couturaud
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D018427:Breast Implants / Q000009:adverse effects* / Q000706:statistics & numerical data*; D001943:Breast Neoplasms / Q000601:surgery*; D005260:Female; D005602:France; D005607:Fraud; D006801:Humans; D008875:Middle Aged; D011475:Prosthesis Failure; D012189:Retrospective Studies
references.citation: Ho A, Cordeiro P, Disa J, et al.. Long-term outcomes in breast cancer patients undergoing immediate 2-stage expander/implant reconstruction and postmastectomy radiation. Cancer 2012;118:2552–2559.
references.citation: de la Peña-Salcedo JA, Soto-Miranda MA, Lopez-Salguero JF. Back to the future: A 15-year experience with polyurethane foam-covered breast implants using the partial-subfascial technique. Aesthetic Plast Surg. 2012;36:331–338.
references.citation: Henriksen TF, Hölmich LR, Fryzek JP, et al.. Incidence and severity of short-term complications after breast augmentation: Results from a nationwide breast implant registry. Ann Plast Surg. 2003;51:531–539.
references.citation: Bengtson BP, Van Natta BW, Murphy DK, Slicton A, Maxwell GP; Style 410 U.S. Core Clinical Study Group. Style 410 highly cohesive silicone breast implant core study results at 3 years. Plast Reconstr Surg. 2007;120:40S–48S.
references.citation: Neaman KC, Albert M, Hammond DC. Rupture rate and patterns of shell failure with the McGhan Style 153 double-lumen breast implant. Plast Reconstr Surg. 2011;127:47–53.
references.citation: Spear SL, Murphy DK, Slicton A, Walker PS; Inamed Silicone Breast Implant U.S. Study Group. Inamed silicone breast implant core study results at 6 years. Plast Reconstr Surg. 2007;120(Suppl 1):8S–16S.
references.citation: Hölmich LR, Friis S, Fryzek JP, et al.. Incidence of silicone breast implant rupture. Arch Surg. 2003;138:801–806.
references.citation: Hedén P, Nava MB, vanTetering JP, et al.. Prevalence of rupture in inamed silicone breast implants. Plast Reconstr Surg. 2006;118:303–308.