The new Natrelle 410 cohesive gel implants have been conditionally approved by the FDA, but Dr. Widder explains why his practice is taking a wait and see approach. The natural look and feel of silicone and saline implants are an important consideration for those seeking cosmetic improvements.
They have been gaining a lot of interest lately, but for the most part I really recommend people stick with the softer silicone or saline implants for a natural look and feel.
Q: What exactly are the “Gummy Bear” implants? How do they differ from the implants you prefer?
The “Gummy Bear” type of implants are made of what is called cohesive gel. Their official name is the Natrelle 410 Highly Cohesive Anatomically Shaped Silicone-Gel Filled Breast Implant. They are considered form-stable, which means the gel substance makes them firmer than can either silicone or saline. They are being manufactured by the healthcare company Allergan, Inc. What they claim is that the implants will provide a natural “tear-drop” shape and that there will be less leakage in the case of rupture. These claims are not yet proven.
Q: Do the “Gummy Bear” implants have official approval for use?
The Food and Drug Administration (FDA) gave them conditional approval in February of this year, which sparked the current buzz about them. What people don’t realize is that the FDA’s conditional approval is not an endorsement. Jeffrey Shuren, M.D., who is the director of the FDA’s Center for Devices and Radiological Health said, “We will be looking at the results from post-approval studies that will focus on their long-term safety and effectiveness.” So Allergan, Inc. will be conducting a study that will follow 2,000 women and will take ten years. Basically, the “Gummy Bear” implants are just entering a major trial stage.
Q: Do you have a sense of what the popularity or importance of these new implants might be in the future?
I believe they may show some promise for reconstructive surgery. I don’t prefer them for the cosmetic surgery I do. They are firmer and because of that, a larger incision is needed. They can’t be inserted through a subareolar incision, which is the method I prefer to use.
I’m not the only surgeon who is wary of taking up the “Gummy Bear” fad. Many doctors want to take their time to learn about them and to be sure they are making the right decision for each patient. Dr. Oren Lerman of Lenox Hill Hospital in New York City commented on this to CBS in February. He said, “These new form-stable implants are not necessarily a better product or a better choice for all women.”
I agree with that statement. I still believe that for augmentation, saline implants are the best. There is less scarring and they have the feel of a natural breast. My patients love the results they get from saline implants.
Dr. Shlomo Widder, the “D.C. Butt Doctor,” offers premium services to fit every cosmetic surgery need in Northern Virginia, the Washington, D.C. metropolitan area, and beyond. To find out more about the Widder Cosmetic & Plastic Surgery Center, stop by during office hours: 9 – 5pm, Mon – Fri, or visit our website at: www.widderplasticsurgery.com.