Scottsdale/Phoenix Arizona
More Results From Breast Implant Study
Results of a Multi Center Study - May 1998
Scott Spear, MD presented these results at the May 1998 Annual Meeting of the American Society for Aesthetic Plastic Surgery in Los Angeles. This was a Multi-Center study, funded by McGhan, one of the breast implant manufacturers. It was started in 1990, before the excitement about breast implants that eventually led to the FDA moratorium on the use of silicone gel implants, and was initially planned to be a definitive study for the FDA to use to evaluate those implants. However, the FDA changed the requirements for those studies after this one was started.
As Dr. Spear pointed out, it is difficult to get accurate long-term results on surgery such as this because of the difficulty in following patients over a number of years. This multi-center study was able to follow 70% of patients over the four year period.
As noted on the previous page, Dr. Spear reported an 8.9% deflation rate. This is a per patient (not per-implant) rate, over four years, in Saline implants used for augmentation. He also reported the following for Silicone Gel implants used for augmentation:
| 4 Year Risk Rates, Silicone Gel Implants for Augmentation, Per Patient | ||
|---|---|---|
| 4 Year Risk | 95% Confidence Interval | |
| Infection | 1% | 0.1%-1.9% |
| Capsular Contracture | 11.8% | 5.9%-14.7% |
| Rupture | 2.6% | 1.2%-4.9% |
| Explantation | 6.2% | 4.1%-8.3% |
As Dr. Spear noted, "Rupture" means "Known Rupture"; it is generally not possible to know whether an implant is ruptured unless special studies are done, and even then it may not be possible to know.
The study also looked at whether texturing on the surface made a difference in capsular contracture rate. There was no significant difference in capsular contracture in smooth vs. textured surface saline implants, but textured gel implants had a significantly lower contracture rate than smooth gel implants (9.2% vs. 15.8%).
This information is provided for general information only. Please consult with your local Plastic Surgeon for specific information about your own situation. I recommend that you see a Plastic Surgeon certified by the American Board of Plastic Surgery. In the United States and Canada, call 8/4PLASTIC for the names of board-certified Plastic Surgeons in your area.