Monday, February 25, 2013
DR. LEWIS OBI CLEARED BY ALLERGAN TO BEGIN RECEIVING NATRELLE STYLE 410 FORM-STABLE (GUMMY BEAR) IMPLANTS THIS WEEK
On the evening of February 21, 2013, Dr. Lewis Obi was notified by Allergan corporation’s Stacee Wenk that The Food and Drug Administration approved the Natrelle 410 “Gummy Bear” implants for use in the United States. The next day, Dr. Lewis Obi became one of the first plastic surgeons in the U.S. to become certified as an approved plastic surgeon to use these implants with his patients. Last month, Dr. Lewis Obi discussed the eminent release of these implants under the LJO review section of his website. See GUMMY BEAR (STYLE 410) BREAST IMPLANTS REVISITED.
Allergan, Inc. manufactures the Natrelle 410 implants which have been successfully used in Europe and Canada for more than a decade. The. FDA finally approved the Natrelle 410 “Gummy Bear” implants after reviewing the study that was conducted on 941 females over seven years. There have been significant complications observed in previous breast implants, including, implant removal, tightening of the area around the implant (capsular contracture), uneven appearance, high incidence of re-operation and infection. The capsular contracture (hard distorted breasts) incidence is 75% less apt to occur with the new “410” implants. Patient approval of the solid shape-stable “Gummy Bear” implants is 96.5% in primary augmentation. Jeffrey Shuren, MD, director of the FDA's Center for Devices and Radiological Health said that the data reviewed has shown promising signs of long-term safety and high effectiveness with the newly released Shape Stable Natrelle 410 implants.
Dr. Lewis Obi, always on the forefront of new technology, will be receiving his supply of Natrelle 410 implants this week. To date, Dr. Obi’s practice has a back log of dozens of patients who are in need or have requested these new implants. These implants are suitable for women 22 or older and are effective both for cosmetic augmentations and for breast reconstruction after mastectomy. There is a slightly greater cost for these implants and the surgical technique has to be executed in a very precise manner by the plastic surgeon. It is Dr. Obi’s opinion that these procedures should be performed in a controlled licensed surgery center with an experienced staff of nurses, OR techs and anesthesiologist. Because of the solid and highly cohesive filler material of the 410 implant, a larger fold incision is required for most patients. However, expert placement and incision closure avoids noticeable scars in the vast majority of patients.