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Cirugía Plástica Ibero-Latinoamericana

versión On-line ISSN 1989-2055versión impresa ISSN 0376-7892


CARDENAS-CAMARENA, L. et al. Prospective observational multicenter study on PIP® implants placed in 12 years. Cir. plást. iberolatinoam. [online]. 2014, vol.40, n.4, pp.385-393. ISSN 1989-2055.

Despite the controversy with PIP® implants (Poly Implant Prothèse, France) there are few studies about it, so we decided to make a multicenter analysis in our environment to determinate the characteristics and clinical behavior of these implants. A multicenter, prospective, observational study including 7 certified plastic surgeons that for a period of 12 years had placed PIP® implants was performed. All patients attending evaluation were clinical examined and with breast ultrasound. All findings and data in those who underwent surgery for implants review were analyzed. Between January 2012 and February 2013, 184 patients attended for consultation of 1315 who had been operated between 1998 and 2010 (14%), evaluating a total of 368 implants. Only 39 patients (21.2%) had symptoms. By breast ultrasound, 322 implants (87.5%) were reported as intact and 46 (12.5%) broken. Of the patients reviewed, 55 (30%) were not reoperated for not having evidence of rupture, while 129 patients (70%) decided to be operated. Of these, only 46 had rupture ultrasound data (36%). During surgery 213 implants (83%) were found without damage, and 45 implants were found damaged (17.8%). There were no data of malignancy in biopsy specimens taken from the capsule or periprosthetic fluid; there was no bacterial growth. The rupture rate proven, 17.8%, was higher than that presented by other studies but with shorter follow-up time. No irritation symptoms or breast symptoms were found in patients with intact implants. There was no toxicity data in capsules or in the liquid in patients with broken implants. Based on all this we consider that is not mandatory to remove PIP® implants as a routine measure, but should be done when there is evidence or suspicion of rupture. We believe that breast ultrasound is highly reliable for evaluating the integrity of breast implants.

Palabras clave : Breast implants; Breast implants rupture; Breast implants complications.

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