In November, 2006 the FDA approved the return of silicone gel breast implants for general use in cosmetic breast surgery after a 15 year hiatus when the FDA restricted access due to safety concerns. Although I have been using silicone gel breast implants for only specific cases since then, i.e. congenital breast problems, patients with failure of saline implants, breast reconstruction patients and those patients needing an augmentation and a mastopexy or lift with very thin tissue. Now these implants can be used in most all cosmetic breast patients with certain conditions. Because I have completed nearly 3,000 operations with breast implants, a third using silicone implants, this is a timely topic.
Silicone gel breast implants have been studied and scrutinized more than any medical device in history. Now plastic surgeons will have a choice in offering silicone gel filled or saline filled implants and the patients will have an informed choice. Literally when shit hit the fan in 1991, the FDA pulled gel implants off the market for general use. At the time the trial lawyers were circling like buzzards allegedly seeking restitution for patients. At that time I was the local president of the Kansas City Plastic Surgical Society and we had to calm my patients and others to ease their feelings that they were sitting on some sort of a time bomb. Granted, the gel implants were not made as well as our new cohesive implants of today and had a very high leakage rate and a high incidence of capsular contraction or firmness. None of this was admitted by the implant manufacturers, most of whom went out of business. These companies went bankrupt and most of the trial lawyers dispersed because of the lack of deep pockets to pick. Subsequently the new implant companies, the FDA and our plastic surgical societies proceeded in a 15 year process of scientific reviews, clinical trials and extensive data collection to determine the benefits and risks of gel implants. Since most plastic surgeons are committed to our patients’ safety and education, these numerous studies have shown that silicone gel implants have a significant psychological and physical benefit for women choosing these procedures and science has won out. All patients need to know of the inherent risks before making a choice. Please refer to www.memorygel.com for more information from the implant company.
My experience still dictates to proceed with caution with my patients’ health and well-being of the utmost importance. So, yes, I’ll be using silicone gel breast implants in my patients, but still the vast majority of my patients will continue to undergo cosmetic breast surgery with saline implants. In my surgical practice in the last 15 years, augmentation with saline implants has reached a reasonable gold standard and are appropriate for most patients. The exceptions, those patients wishing silicone gel implants, will be patients who strongly desire these type of implants after extensive informed consent, patients with failure of saline implants, i.e. frequent ruptures, wrinkling and dislike for the feel, and patients with minimal breast tissue and muscle (very thin chest wall and tissue) and those patients with thin skin and tissue requiring lifts with augmentations.
With the plethora of reported complications from silicone, my personal studies have shown a high satisfaction in those above mentioned patient categories with some accepted drawbacks. Silicone gel breast implants require a longer incision, a higher incidence of capsular contraction or firmness, are more costly and need more follow-up including MRI studies at three and five years to detect rupture. The old silicone implants when ruptured would ooze a liquid gel but now the implants are cohesive and a cut in the implant will not leak throughout the tissue. Even with accepted complications, there is a greater than 95% satisfaction rate with silicone gel implants.