Recall management of patients with Rofil Medical breast implants

Published:April 07, 2014DOI:



      Some Rofil Medical breast implants are relabelled Poly Implant Prothèse (PIP) implants, and it is recommended that Rofil implants be managed in the same way as PIP implants. We report the results of a systematic recall of patients who had received Rofil implants.


      All patients who received Rofil implants at our centre were identified and invited for specialist consultation. In patients who opted for explantation, preoperative and intraoperative work-up was performed in accordance with national guidelines and analysed. In cases suspicious for rupture, an MRI scan was performed.


      Two-hundred and twenty-five patients (average age 56; range 28–80) received a total of 321 Rofil implants an average of 5.8 (range 1–11) years previously, 225/321 (70%) implants were used for reconstruction after breast cancer. A total of 43 implants were removed prior to 2011, mainly due to capsular contracture (CC). A total of 188 patients were still affected at the time of recall. Of the 188 patients, 115 (61%) attended for specialist consultation, of which 50 (44%) requested immediate implant removal. To date, 72 of 115 (63%) women attending consultation (38% of all affected) have chosen explantation, 66 of 72 (92%) opting for new implants. Of the 108 explanted implants, 25 (23%) had capsular rupture and 57 (53%) had implant bleeding. Preoperative clinical assessment was unreliable for predicting CC or rupture.


      The majority of patients attended for consultation and requested explantation. The quality of the explanted Rofil implants was comparable to PIP implants, with a higher rupture prevalence compared with other, non-affected implants. Nevertheless, the acceptance of breast implants for reimplantation remained high.


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        • Reyal F.
        • Feron J.G.
        • Leman Detour S.
        • et al.
        The impact of poly implant prothese fraud on breast cancer patients: a report by the institut curie.
        Plast Reconstr Surg. 2013; 131: 690-695
        • Manickavasagar T.
        • Morritt A.N.
        • Offer G.J.
        Bilateral supraclavicular swelling: an unusual presentation of ruptured Poly Implant Prosthese (PIP) breast implants.
        J Plast Reconstr Aesthet Surg. 2013; 66: 267-269
        • Smith T.J.
        • Ramsaroop R.
        Breast implant related anaplastic large cell lymphoma presenting as late onset peri-implant effusion.
        Breast. 2012; 21: 102-104
        • Jewell M.
        • Spear S.L.
        • Largent J.
        • Oefelein M.G.
        • Adams Jr., W.P.
        Anaplastic large T-cell lymphoma and breast implants: a review of the literature.
        Plast Reconstr Surg. 2011; 128: 651-661
        • Gubitosi A.
        • Docimo G.
        • Ruggiero R.
        • et al.
        Breast implant (PIP), chronic inflammation and cancer: is there a connection? Case report.
        Ann Ital Chir. 2012; 83
        • Bfarm
        Empfehlungen des BfArM für Patientinnen mit PIP-Brustimplantaten.
        2011 ([accessed 23.03.14])
        • Afssaps
        Breast implants with silicone based gel filling from Poly Implant Prothèse Company: update of tests results.
        2011 ([accessed 23.03.14])
        • Directorate DoHNM
        Poly Implant Prothese (PIP) breast implants: final report of the Working Group.
        2012 ([accessed 23.03.14])
        • Berry M.G.
        • Stanek J.J.
        The PIP mammary prosthesis: a product recall study.
        J Plast Reconstr Aesthet Surg. 2012; 65: 697-704
        • Heil J.
        • Gondos A.
        • Rauch G.
        • et al.
        Outcome analysis of patients with primary breast cancer initially treated at a certified academic breast unit.
        Breast. 2012; 21: 303-308
        • Afssaps
        Update of recommendations for women with silicone filled Poly Implant Prosthesis (PIP) breast implants.
        2011 ([accessed 23.03.14])
        • Lampert F.M.S.M.
        • Grabin S.
        • Stark G.B.
        The “PIP scandal” – complications in breast implants of inferior quality: state of knowledge, official recommendations and case report.
        Geburtsh Frauenheilk. 2012; 72: 243-246
        • Spear S.L.
        • Baker Jr., J.L.
        Classification of capsular contracture after prosthetic breast reconstruction.
        Plast Reconstr Surg. 1995; 96 ([discussion 24]): 1119-1123
        • Bengtson B.P.
        • Van Natta B.W.
        • Murphy D.K.
        • Slicton A.
        • Maxwell G.P.
        Style 410 highly cohesive silicone breast implant core study results at 3 years.
        Plast Reconstr Surg. 2007; 120: 40S-48S
        • Spear S.L.
        • Murphy D.K.
        • Slicton A.
        • Walker P.S.
        Inamed silicone breast implant core study results at 6 years.
        Plast Reconstr Surg. 2007; 120 ([discussion 7S-8S]): 8S-16S
        • Collis N.
        • Litherland J.
        • Enion D.
        • Sharpe D.T.
        Magnetic resonance imaging and explantation investigation of long-term silicone gel implant integrity.
        Plast Reconstr Surg. 2007; 120: 1401-1406
        • Handel N.
        • Cordray T.
        • Gutierrez J.
        • Jensen J.A.
        A long-term study of outcomes, complications, and patient satisfaction with breast implants.
        Plast Reconstr Surg. 2006; 117 ([discussion 68–72]): 757-767
        • Berry M.G.
        • Stanek J.J.
        PIP implant biodurability: a post-publicity update.
        J Plast Reconstr Aesthet Surg. 2013; 66: 1174-1181
        • Hibbeler B.
        Fehlerhafte Brustimplantate: Tausende Frauen in Deutschland betroffen.
        Dtsch Arztebl Int. 2012; 109: 76-77
        • Swarts E.
        • Kop A.M.
        • Nilasaroya A.
        • Keogh C.V.
        • Cooper T.
        Rupture of poly implant prothese silicone breast implants: an implant retrieval study.
        Plast Reconstr Surg. 2013; 131: 480e-489e
        • Maijers M.C.
        • Niessen F.B.
        Prevalence of rupture in poly implant prothese silicone breast implants, recalled from the European market in 2010.
        Plast Reconstr Surg. 2012; 129: 1372-1378
      1. SCENIHR (Scientific Committee on Emerging and Newly Identified Health Risks) u. Scientific opinion on the Safety of Poly Implant Prothèse (PIP) Silicone Breast Implants. [accessed 23.03.14].

        • Crouzet C.
        • Gangloff D.
        • Chaput B.
        • Grolleau J.L.
        • Garrido I.
        Outcome at 18 months after the recall of Poly Implant Prosthesis. Experience of a cancer center.
        Ann Chir Plast Esthet. 2012; 57: 9-15
        • Quaba O.
        • Quaba A.
        PIP silicone breast implants: rupture rates based on the explantation of 676 implants in a single surgeon series.
        J Plast Reconstr Aesthet Surg. 2013; 66: 1182-1187
        • Handel N.
        • Garcia M.E.
        • Wixtrom R.
        Breast implant rupture: causes, incidence, clinical impact, and management.
        Plast Reconstr Surg. 2013; 132: 1128-1137
        • Bassetto F.
        • Scarpa C.
        • Vindigni V.
        • Doria A.
        The periprosthetic capsule and connective tissue diseases: a piece in the puzzle of autoimmune/autoinflammatory syndrome induced by adjuvants.
        Exp Biol Med (Maywood). 2012; 237: 1117-1122
        • Kolios L.
        • Hirche C.
        • Spiethoff A.
        • Daigeler A.
        • Lehnhardt M.
        Complications of Poly Implant Prothese breast implants: the current discussion.
        Expert Rev Med Devices. 2013; 10: 167-170
        • 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
        • Lavigne E.
        • Holowaty E.J.
        • Pan S.Y.
        • et al.
        Breast cancer detection and survival among women with cosmetic breast implants: systematic review and meta-analysis of observational studies.
        BMJ. 2013; 346: f2399
        • Cordeiro P.G.
        • McCarthy C.M.
        A single surgeon's 12-year experience with tissue expander/implant breast reconstruction: part II. An analysis of long-term complications, aesthetic outcomes, and patient satisfaction.
        Plast Reconstr Surg. 2006; 118: 832-839
        • Cordeiro P.G.
        • McCarthy C.M.
        A single surgeon's 12-year experience with tissue expander/implant breast reconstruction: part I. A prospective analysis of early complications.
        Plast Reconstr Surg. 2006; 118: 825-831
        • Berry M.G.
        • Stanek J.J.
        Ultrasonography in PIP implant scanning: a cautionary tale.
        J Plast Reconstr Aesthet Surg. 2012; 65: 1439-1440
        • Cher D.J.
        • Conwell J.A.
        • Mandel J.S.
        MRI for detecting silicone breast implant rupture: meta-analysis and implications.
        Ann Plast Surg. 2001; 47: 367-380
        • Dieterich M.
        • Stubert J.
        • Stachs A.
        • et al.
        Ruptured poly-implant protheses breast implant after aesthetic breast augmentation: diagnosis, case management, and histologic evaluation.
        Aesthetic Plast Surg. 2013; 37: 91-94
        • Zuckerman D.
        • Booker N.
        • Nagda S.
        Public health implications of differences in U.S. and European Union regulatory policies for breast implants.
        Reprod Health Matters. 2012; 20: 102-111