Scottsdale – I decided to do a follow up review on this very important article. I originally covered the findings in this article on the blog earlier this year, but I have decided to take a close look the numbers. This article originally appeared in the May 2009 issue of Aesthetic Plastic Surgery. This blog will include only a review of the cosmetic augmentation and revision augmentation subgroups. A separate blog article will cover the reconstructive subgroups later.

Silicone gel filled implants have been approved in the U.S. since November 2006. The FDA requires follow up studies to be completed through 10 years. This article summarizes the findings involved with Mentor Corporation Memory Gel Core Study at 6 years. There were 1008 patients enrolled in this study. The subgroups included 552 augmentation, 145 revision augmentation, 251 reconstruction, and 60 revision reconstruction patients.

A close look at the augmentation subgroup demonstrates the 6-year rupture rate at a very low 1.1%. This is the lowest reported implant leakage rate ever reported for a long-term implant study. In the group, there occurred a 6-year revision totaling 19.4% of patients. The most common reasons for re-operation in this sub-group was for the treatment of capsular contracture (33.3%) and size change (14.8%). There was an infection rate of 1.6% in the subgroup.

Capsular contracture is the scar tissue that develops around the implant and can tighten over time as a reaction to the implant. It is known that implants placed above the muscle have a higher risk of developing capsular contracture. It is believed that a certain number of contractures cannot be prevented. Currently, plastic surgeons utilized several techniques to reduce the incidence of contracture. However, patients should realize that even this study, performed by experts in breast surgery, contracture of the capsule over the implant will occur and cannot be totally preventable.

The overall rate of capsular contracture in the augmentation subgroup was 9.8% after 6 years. The article does not tell us how many patients had implants above the muscle. The most common operation performed to treat capsule contracture is capsulectomy or capsulectomy (removal of the tissue) with implant exchange. In the subgroup, 19.7% of the implants removed were due to capsule contracture while of the implants removed, 51.5% of the implants simply to change the size of the implants.

The revision augmentation numbers are even more interesting. The rupture rate for implants in this scenario was 11.4%. Additionally, capsular contracture (22.4%) and reoperation (33.4%) numbers were also higher. The more likely explanation for the higher numbers is that revision breast surgery is more technically challenging and certainly is riskier than primary breast augmentation. Patients who re contemplating revision breast surgery should be aware of the higher risks associated with revision surgery and implant exchange.

This article demonstrates that silicone gel filled breast implants are safe and effective. This study also demonstrates that complications can occur after cosmetic breast surgery and patients should be mentally prepared for these challenges. A 1.1% rupture rate at 6-years for cosmetic breast augmentation using Memory Gel Filled implants is the lowest reported rupture rate – ever.