Stevens W Grant, Hirsch Elliot M, Stoker David A, Cohen Robert
Marina Plastic Surgery Associates, Marina del Rey, CA, USA.
Plast Reconstr Surg. 2006 Jun;117(7):2175-8; discussion 2179-81. doi: 10.1097/01.prs.0000218199.28082.9d.
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.
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.
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.
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.
本研究首次对1000例植入物进行了大容量比较，对比了聚植入假体预填充纹理盐水乳房植入物与对照组曼托Siltex纹理盐水植入物的放气率。
将连续的500例聚植入假体预填充纹理盐水乳房植入物与连续的500例曼托Siltex乳房植入物进行比较。对每个乳房植入物进行为期4年的评估，并记录年放气率（给定年份内的放气次数除以植入物总数）和累积放气率（到给定年份的放气累计总数除以植入物总数）。在第1年使用Fisher精确检验计算统计学显著性，在第2年至第4年使用卡方分析。
聚植入假体植入物的累积放气率如下：第1年，1.2%；第2年，5.6%；第3年，11.4%；第4年，15.4%。曼托植入物的累积放气率为：第1年，0.2%；第2年，0.6%；第3年，1.6%；第4年，4.4%。在第1年，放气率之间的差异无统计学显著性（Fisher精确检验，p>0.05）。然而，在第2年（卡方值13.29；p<0.001）、第3年（卡方值37.91；p<0.001）和第4年（卡方值32.69；p<0.001），差异具有统计学显著性。
在第2年、第3年和第4年，聚植入假体预填充纹理盐水乳房植入物与曼托Siltex乳房植入物的总体放气率存在统计学显著性差异。4年后，聚植入假体植入物15.56%的累积放气率比曼托Siltex植入物4.31%的放气率高出3.5倍多。聚植入假体植入物中较高的放气率可能有几个因素导致，包括植入前可能的体外放气和硅胶外壳固化技术。然而，在权衡聚植入假体乳房植入物的风险和益处时，必须考虑到这种具有统计学显著性的放气差异。
