2013 will be the year American women can reclaim their cleavage. At long last the U.S. FDA approved Allergan’s Natrelle 410 Highly Cohesive Anatomically Shaped Silicone-Gel Filled Breast Implant to increase breast size(augmentation) in women at least 22 years old and to rebuild breast tissue(reconstruction) in women of any age.The FDA requires that Allergan conduct a series of post-approval studies to assess long-term safety and effectiveness outcomes and the risks of rare disease. This marks the 4th FDA-approved silicone gel-filled breast implant product available in the U.S. manufactured by three companies: Allergan, Mentor, and Sientra.
Cohesive gel implants, also referred to as “gummy bear implants,” are relatively new to Americans although they have been talked about here for eons and available in Europe, Latin America, and Asia for years. In fact, American women have been denied this advancement in breast implant technology until Sientra got their FDA nod for anatomical silicone gel implants in March of 2012.
New York Plastic Surgeon Dr. Tracy Pfeifer is an advocate of the Allergan Natrelle style 410 cohesive gel implants. She was selected to be an investigator for the 410 study because of her extensive experience with anatomic shaped implants. As she says, “They look like a natural breast, as they are fuller at the bottom and tapered at the top. They are advantageous compared to other types of implants because of this natural shape and because of a lower rupture rate compared to round gel implants.”
So what is the difference between these and other silicone gel implants already available?
As Dr. Pfeifer explains, “The new style 410 implants from Allergan are the next generation of silicone breast implants. The silicone gel does not flow but rather maintains its shape. This characteristic makes these implants very powerful in terms of creating a natural-looking breast. The implants were developed to be an improvement on the round silicone gel implants we have been using for years. The studies have shown that there is less incidence of capsular contracture or hardening, less rippling, and because the implant maintains its shape, the shape of the breast looks more natural.”
For years, this type of high-cohesive silicone gel breast implants were only available outside the U.S. or for women who were fortunate enough to get into the clinical trials being held in the U.S. through a select group of board certified plastic surgeons. According to New York Plastic Surgeon Bryan G. Forley, “I am looking forward to finally having the Natrelle 410 implants available to offer to my patients. It is important that we can provide state-of-the-art solutions to women now and in the future. They have been asking about high cohesive gel implants for years now. The more safe and effective choices available, the better for surgeons and for patients.”
According to the American Society of Plastic Surgeons (ASPS) there were 286,000 breast augmentation procedures performed in the U.S. in 2012, which sounds like a huge number, but was actually down by 7% over 2011. With new options available to women, we can expect to see that number jump in 2013.
Other breast implant news is the European crisis surrounding the recall of breast implants manufactured by now-defunct Poly Implant Prothese (PIP) in France. Estimates are that 500,000 women could have these implants, 30,000 in France, and 50,000 in the U.K. The good news is that according to Dr. Bruno Alfandari, President of Le Syndicat National Des Chirurgiens Plasticiens (Sncpre.Org) in France, only 14,000 patients to date have been operated on and the majority of the implants removed were normal with no serious complications or side effects. Therefore, public outrage and fear has calmed and there are fewer women demanding to have their implants removed or exchanged. Fortunately, we can thank the U.S. FDA that the PIP implants never even got close to getting approved in the U.S. Perhaps the only positive outcome of the PIP crisis is that there are now more factory inspections being done in the U.K. and France, more and better product testing and clinical trials are called for, and stricter labeling and warnings of potential risks for implants required across the pond.
What’s coming next in the field of breast implants? Mentor is hoping that it will be their Siltex® Contour Profile Gel Mammary Prosthesis.
If you are considering breast enhancement, find a surgeon who is experienced and whom you can trust, and see at least 3 surgeons in consultation. To find a board certified plastic surgeon for breast augmentation, breast lifts, or breast reconstruction, visit ASPS or ASAPS.