Surgical Tribune Europe

Five-year study monitors women with breast implants

By Surgical Tribune
June 18, 2014

LONDON, UK: Silicone implant manufacturer Eurosilicone has published safety data collected from a five-year review. The multicentre study monitored 1,010 Cristalline Paragel implants made by Eurosilicone and implanted in 535 women undergoing either augmentation or reconstructive surgery. Each patient was followed up at three months post-surgery, and then annually thereafter.

In cases in which implants were used in reconstructive surgery after a cancer diagnosis, Eurosilicone’s implants showed 50 per cent fewer removals than its nearest competitor.

Implant removal may be required for a number of reasons and figures relating to this formed a large part of the study. Most reoperations were performed for cosmetic reasons rather than reconstructive ones. Capsular contracture (an abnormal reaction of the body by forming a capsule in the breast tissue that hardens) was just 1.9 per cent, while the most frequent reason for reoperation was women desiring a mastopexy (10.7 per cent), followed by scarring (3.6 per cent). Most of the devices that were removed were associated with patients having a breast reconstruction. Of the 365 women undergoing primary augmentation, just 4.4 per cent had their implants removed during the five-year period.

Rupture rates were exceptionally low, with just one of the 1,010 implants found to be ruptured on examination. No ruptures were found during the 35 reoperations and the total risk of rupture was assessed at just 0.4 per cent per patient.

The study, titled “Five-year safety data for Eurosilicone’s round and anatomical silicone gel breast implants”, was published in the April issue of the Plastic and Reconstructive Surgery—Global Open journal.

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