Breast augmentation using silicone implants is the most popular method used today by most plastic surgeons. While saline breast implants dominated from 1991 to 2006, since they were the only type of implants available, that changed in 2006. The FDA approved silicone-containing implants in 2006, marking their return after fifteen years of study and evaluation.
As part of the re-approval of silicone breast implants by the FDA was the condition that the manufacturers were required to continue to study the patients long-term that were used to gain the approval. Inaddition, they were required to conduct post-approval studies on implanted women. A recent FDA panel in meeting with the manufacturers (Allergan and J & J Mentor) has looked at that information. According to reports, about 60% of women that were part of the original approval studies have been followed for eight to ten years. Roughly 80,000 women have been enrolled by both manufacturers since 2006 but followup rates have not been as good at the three year mark after their surgery.
The FDA states that silicone breast implants are safe and effective and will remain available in the U.S. They will work with the manufacturers to increase patient participation in the follow-up studies so that substantial long-term data will be obtained. It is no surprise to me that long-term follow-up of implanted patients is difficult because the motivation for patients and plastic surgeons to do so is very low. If a women is doing fine with no problems, she is not very motivated to come back for future follow-ups. More pertinently, the time and paperwork required for plastic surgeons to record and submit follow-up paperwork to the manufacturers is substantial. In a busy plastic surgery practice that does a high volume of breast augmentations, it takes a fully dedicated person to properly perform this job. This is a substantial expense. The solution to both of these problems is reimbursement. That is the real solution to generating better follow-up data.
One of the findings from the FDA panel was that there is a ‘significant complication rate’ with silicone breast implants. One set of data involving a group of women who were part of the original studies used to gain approval of the implants in 2006 showed 20 percent to 40 percent of women receiving implants for augmentation and 40 percent to 70 percent of women who received implants for reconstruction (usually after breast cancer) had to have another operation in the first eight to ten years after they received their implants. The most common breast implant complications were capsular contracture, implant rupture, scarring, pain and infection.
The complication rate show be neither a surprise or unexpected. Doctors and patients alike must remember that these are medical devices, foreign bodies that are placed inside the body. While the body will tolerate them (not reject them from an immunologic standpoint), they are not natural tissues and some expected complications in a number of patients can eventually be expected. This is true of every medical device ever implanted in humans. What is unique about breast implants is that they are placed in a fairly superficial position (which is why under the muscle is better) and are subject to extreme aesthetic scrutiny. A fair number of revisional surgeries are for aesthetic reasons such as asymmetry, size and shape. If you throw these complications out, the number of revisional surgeries would drop substantially. In addition, many implants for breast reconstruction are placed in the face of radiation and diminished soft tissue coverage, a perfect setup for high complication rates and the need for numerous revisional surgeries.
This FDA panel review is a reminder that breast implants should not be perceived as lifelong devices and that the potential need for revisional surgery after implantation is far from rare.
Dr. Barry Eppley
Indianapolis, Indiana