A Comparison of 500 Pre-filled Textured Saline Breast ...



Title: A Comparison of 500 Pre-filled Textured Saline Breast Implants versus 500 Standard Textured Saline Breast Implants: Is There a Difference in Deflation Rates?

Authors: Elliot M. Hirsch, BA; W. Grant Stevens, MD; David A. Stoker, MD; Robert Cohen, MD

To date, no large study of the deflation rates of PIP pre-filled textured saline breast implants has been published. This study provides the first large series (1000 implant) comparison of the deflation rates of PIP pre-filled textured saline breast implants versus a control group of Mentor Siltex textured saline implants. The goal of this study is to provide information regarding the deflation rates of PIP pre-filled textured saline breast implants as compared to standard Mentor Siltex textured saline implants.

Methods: A consecutive series of 500 PIP pre-filled textured saline breast implants was compared to a consecutive series of 500 Mentor Siltex breast implants. Each breast implant was evaluated for a four-year period, and the annual deflation rate (number of deflations during a given year divided by the total number of implants remaining after accounting for previous deflations) and cumulative deflation rate (cumulative total of deflations through a given year divided by the total number of implants [500]) were recorded. Statistical significance was calculated using a Fisher’s exact test at year one and a chi square analysis at the remaining years.

Results: The cumulative deflation rate of the PIP implants are as follows: year one= 1.2%, year two= 5.6%, year three= 11.4%, and year four= 15.4%. The cumulative deflation rate of the Mentor implants are as follows: year one= 0.2%, year two= 0.6%, year three= 1.6%, and year four 4.4%.

At year one, the difference between the cumulative deflation rates is not statistically significant at the (= 0.05 significance level (Fisher’s exact test, p >0.05); however, at year two (chi square 13.29, p ................
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