Background: This study provides the first large-volume (1000 implant) comparison of the deflation rates of Poly Implant Prosthesis prefilled textured saline breast implants versus a control group of Mentor Siltex textured saline implants.
Methods: A consecutive series of 500 Poly Implant Prosthesis prefilled textured saline breast implants was compared with a consecutive series of 500 Mentor Siltex breast implants. Each breast implant was evaluated for a 4-year period, and the annual deflation rate (number of deflations during a given year divided by the total number of implants) and cumulative deflation rate (cumulative total of deflations through a given year divided by the total number of implants) were recorded. Statistical significance was calculated using the Fisher's exact test at year 1 and the chi-square analysis at years 2 through 4.
Results: The cumulative deflation rates of the Poly Implant Prosthesis implants was as follows: year 1, 1.2 percent; year 2, 5.6 percent; year 3, 11.4 percent; and year 4, 15.4 percent. The cumulative deflation rates of the Mentor implants was: year 1, 0.2 percent; year 2, 0.6 percent; year 3, 1.6 percent; and year 4, 4.4 percent. At year 1, the difference between deflation rates was not statistically significant (Fisher's exact test, p > 0.05). However, at year 2 (chi-square, 13.29; p < 0.001), year 3 (chi-square, 37.91; p < 0.001), and year 4 (chi-square, 32.69; p < 0.001), the difference was statistically significant.
Conclusions: There was a statistically significant difference between the overall deflation rates of Poly Implant Prosthesis prefilled textured saline breast implants and Mentor Siltex breast implants at year 2, year 3, and year 4. After 4 years, the 15.56 percent cumulative deflation rate of Poly Implant Prosthesis implants was over 3.5 times higher than the 4.31 percent deflation rate of the Mentor Siltex implants. There may be several factors contributing to the higher deflation rate seen in Poly Implant Prosthesis implants, including possible in vitro deflation before implantation and silicone shell curing technique. Nevertheless, this statistically significant deflation difference must be taken into account when balancing the risks and benefits of Poly Implant Prosthesis breast implants.