Re: Experts call for greater transparency on safety of implants
12 September 2012
We read with interest your article regarding the poly implant prostheses (PIP) safety debacle. The final expert review by Sir Bruce Keogh recently published(1) found no evidence of significant risk to human health. However PIP implants are significantly more likely to rupture or to leak silicone (‘gel bleed’) within 5 years of implantation than alternative cohesive silicone gel implants by a factor of 2-6. This is higher than published(2) rupture rates for Allergan (10% at 10 years) or Mentor (14% at 8 years) breast implants.
When the initial media furore came to light, our Breast unit anticipated that many anxious women would need help and guidance, which might not be readily available from their primary cosmetic company. In collaboration with our Primary Care Trust, we set up separate additional clinics for women with concerns regarding their PIP implants. In total we have seen a further 76 women, whose implants have been inserted by several companies, the majority by Harley medical group (38). The mean age of the implants was 6 years. Sixty five women underwent ultrasonography, and 7 underwent an MRI.
Twelve patients (16%) have been found to have a single implant rupture on imaging, 3 women (4%) had bilateral implant rupture and 5 women (7%) had an axillary siliconoma. Two patients had ‘gel bleed’ identifiable on MRI. We have explanted 5 women’s PIP implants, four with evidence of gel bleed, and a further 8 women are undergoing surgery privately. Our results are similar to a product recall study performed by a private health institution (rupture rate 15.9-33.8%) (3).
We hope that similar problems can be avoided in the future by implant manufacturers and the professionals using implants being more open and transparent to their patients about potential problems of cosmetic implants and more rigorous scrutiny by medical health regulatory agencies.
1. Poly Implant Prosthese (PIP) Breast Implants: Final Report of the Working Group. Department of Health, NHS Medical Directorate. 18th June 2012.
2. FDA update on the Safety of Silicone Gel-filled Breast Implants. Centre for Devices and Radiological Health U.S. Food and Drug Administration. June 2011. (http://www.fda.gov/downloads/MedicalDevices/ProductsandMedicalProcedures...)
3. Berry MD and Stanek JJ. The PIP mammary prosthesis; A product recall study. J Plast Reconstr Aesthet Surg (2012):65, 697-704.
Competing interests: None declared
Royal United Hospital, Bath, Combe Park, Bath BA1 3NG
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