FDA Approves Natrelle 410 Anatomically Shaped Gummy Bear Breast Implants

    NAPLES, FL, March 28, 2013 /24-7PressRelease/ -- The Natrelle 410 Highly Cohesive Anatomically Shaped Silicone-Gel Filled Breast Implant was recently approved by the U.S. Food and Drug Administration for use in cosmetic breast augmentation and breast reconstruction. Dr. Kent V. Hasen, a plastic surgery specialist in the Naples-Fort Myers area, has been certified to use these implants in patients seeking cosmetic and reconstructive breast enhancement.

"These tear-drop-shaped implants, which are commonly referred to as "gummy bear" implants, have been in use in Europe for over 18 years and under study in the United States for over 10 years," says Dr. Hasen. "The 410 style silicone implant is the most common textured implant used in the world."

FDA approval came after the commission reviewed the long-term data from the pivotal trial in the United States that enrolled nearly 1000 patients. In the study, the 410 silicone gel implant performed significantly better than the current responsive (moderately cohesive) silicone gel implants that have been in use in the United States since the 1990s. Most notably is that risk of capsular contracture (hardening around the implant from excess development of scar tissue) at 7 years of the 410 gel implants was nearly 3 times less than that of round gel implants (6.1% for 410 and 15.5% for round gel implants).

Additionally, wrinkling and palpability of the 410 gel implant was only 0.7% and 0.3%, respectively. In the 7 year study, there was a 97% satisfaction rate of the primary breast augmentation patients. Of the 2-3% ruptures noted in some trials between 6 and 8 years after augmentation, there were no cases of gel outside of the breast implant pocket.

"The new 410 shaped gel implants offer many advantages for breast augmentation patients at my Naples-Fort Myers area plastic surgery practice," says Dr. Hasen. "Benefits include a lower risk for capsular contracture, and less visibility and palpability of the implant. I'm able to enhance the volume and shape of the breast while creating a gentle slope in the upper pole of the breast.
"However, these implants are not for all patients seeking breast augmentation. These are not ideal implants for patients with significant breast skin laxity and drooping of the breast."

With any device, there are some tradeoffs with the use of these implants. For this reason, it is very important to seek a very experienced breast implant surgeon who has worked with textured shaped devices.

Dr. Hasen has trained with one of the preeminent 410 gel surgeons in the country, Dr. G. Patrick Maxwell in Nashville, TN, through an Allergan, Inc. scholar preceptorship. Additionally, Dr. Hasen has vast experience with implant-based breast reconstruction at his plastic surgery practice near Fort Myers.

Kent V. Hasen, M.D., is a Naples, Florida, plastic surgeon and medical director of a full-service aesthetic plastic surgery and cosmetic practice, which has developed a strong reputation in South Florida since opening in 2002. Dr. Hasen is certified by The American Board of Plastic Surgery and was named one of the "Top 40 Under 40" in 2006 by Southwest Florida's Gulfshore Business Magazine. Dr. Hasen offers medical spa services and cosmetic surgery for the face, breast and body. He is an active member in The American Society for Aesthetic Plastic Surgery and American Society of Plastic Surgeons.

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