Background: Poly Implant Prothèse implants were recalled in Australia in April of 2010 following concerns of higher than expected rupture rates and the use of unauthorized industrial grade silicone as a filler material. Although subsequent investigations found that the gel filler material does not pose a threat to human health, the important question of what caused a relatively modern breast implant to have such a poor outcome compared with contemporary silicone breast implants is yet to be addressed.
Methods: From a cohort of 27 patients, 19 ruptured Poly Implant Prothèse breast implants were subjected to a range of mechanical tests and microscopic/macroscopic investigations to evaluate possible changes in properties as a result of implantation. New Poly Implant Prothèse implants were used as controls.
Results: All samples, explanted and controls, complied with the requirements for shell integrity as specified in the International Organization for Standardization 14607. Compression testing revealed rupture rates similar to those reported in the literature. Shell thickness was highly variable, with most shells having regions below the minimum thickness of 0.57 mm that was specified by the manufacturer. Potential regions of stress concentration were observed on the smooth inner surfaces and outer textured surfaces.
Conclusions: The high incidence of Poly Implant Prothèse shell rupture is most likely a result of inadequate quality control, with contributory factors being shell thickness variation and manufacturing defects on both inner and outer surfaces of the shell. No evidence of shell degradation with implantation time was determined.
Perth and Nedlands, Western Australia, Australia
From the Department of Medical Engineering and Physics, Royal Perth Hospital, and the Rodin Clinic.
Received for publication July 27, 2012; accepted October 18, 2012.
Presented in part at the 35th Annual Conference of the Australasian Society of Aesthetic Plastic Surgeons, in Darwin, Northern Territory, Australia, July 3 through 7, 2012.
Disclosure: The authors have no commercial associations or financial disclosures that might create a conflict of interest with information presented in this article. No funding was received for this work.
Eric Swarts, B.Sc.; Department of Medical Engineering and Physics, Royal Perth Hospital, Wellington Street, Perth 6847, Western Australia, Australia, firstname.lastname@example.org