Safety and Success Rates of Cohesive Silicone Breast Implants

A recent study, entitled "Silicone Breast Implantation: A Retrospective Review of 1012 Implants Placed By a Single Surgeon," gives new information about the safety and success rates of modern silicone breast implants. The study was presented by Dr. Salvatore J. Pacella at the 2008 joint annual meeting of the California Society of Plastic Surgeons and the Rocky Mountain Association of Plastic Surgeons.

Details of the Study
The statistical analysis covers the thirteen-year experience of one surgeon, Dr. W. Grant Stevens, using Mentor fourth generation cohesive silicone gel breast implants. This type of implant, sometimes referred to as a "gummy bear" implant, can hold its shape even if punctured or otherwise damaged, thanks to additional "crosslinker" in the gel's formula. The firmer gel does not leak out, as did the gel in older implants.

Patient data from 1992 - 2006 was reviewed, and low rates of complication and revision were found. According to Dr. Stevens, the study, "reveals low complication and revision rates and also gives some insights into which factors may lead to implant revision."

Variables, Statistics, and Correlations
A number of different variables were looked at, including patient age, implant size, implant placement method, history of smoking, and previous breast surgery. Researchers looked for statistically significant correlations between these factors, complications, and the need for revisions, but found none. It seems the outcome of the surgery cannot be predicted based on these factors.

Overall complication rate per implant was 3.9%. The most common complications were capsular contracture and abnormal scarring.

8% of patients had revision of at least one implant, however, over a third of these were performed to change the size of the implant, at the patients request. "Factoring out these patients, the revision rate to address surgical complications was actually 5%," said Dr. Stevens.

Average time between implantation and revision was 18.5 months.

Dr. Stevens concluded that the study was "one of the first steps in what I hope becomes a much more thorough and complete set of medical literature on the topic of cohesive silicone gel breast implant safety."