By Jerome Edelstein, MD
THE NATRELLE® COLLECTION
The Natrelle® Collection is the result of more than 30 years of research and refinement in breast implant creation. Allergan, the manufacturer of Natrelle®, is the market leader in implant studies. Allergan continually invests in research and development in order to build a reliable body of clinical data that proves the safety of its products. Coupled with decades of experience in its industry, the company is able to guarantee the high quality of its Natrelle® breast implants in Toronto for breast augmentation.
Patients who receive breast augmentation with Natrelle® implants enjoy unparalleled safety. Part of this commitment to patient safety comes from rigorous implant testing, conducted at our state-of-the-art facilities. Natrelle® products are made to comply with Current Good Manufacturing Practice and national/international standards, undergoing nearly 100 quality control tests before making it to market.
This process can require an Allergan implant to spend up to 12 days in manufacture. After having been sent through materials inspection, product inspection and testing, implants from the Natrelle® Collection are proven to work as intended. Each of the more than ¾ million implants and tissue expanders produced or supplied by Natrelle® per year is subject to this strict level of testing.
CLINICAL EXPERIENCE
As the medical industry continues to evolve and embrace technological innovations, Natrelle® does too. Advances in technology have had an impact on Natrelle®’s approach to the design and manufacture of its silicone gel-filled breast implants. Today, the Natrelle® Collection uses a silicone gel with greater cohesiveness. Its implant shells are also made with a thicker shell and an additional barrier layer — all without sacrificing aesthetic or textural quality.
These advances have helped to ward off implant ruptures. Extensive clinical studies from Allergan have demonstrated that 96.5% of all implants remained intact after six years following surgery in American patients. This low long-term rupture rate is the result of the rigorous testing process that the Natrelle® Collection is passed through before arriving on the market.
Natrelle® provides the medical community with the benefit of its long-term research data as well. The clinical experience that is used in creating the company’s silicone gel-filled implants is frequently studied and referenced in academic journals or peer-reviewed studies.INSPIRA® – The Next Generation of Round Silicone Cohesive Gel Breast Implants
Edelstein Cosmetic is proud to offer patients the latest silicone cohesive gel breast implants from Allergan. Known as INSPIRA®, this innovative line of implants was developed to offer patients even greater choice. There are over 300 types of round, smooth and textured options to choose from. They offer a key benefit: they are filled more fully, and are therefore felt to cause less rippling.
WARRANTY INFORMATION
Natrelle® understands that implants are medical devices and provides quality assurance to help protect you, the patient. The Allergan ConfidencePlus® warranty programs cover all Natrelle® style saline and gel-filled breast implants listed below (applicable breast implants must have been implanted in the United States or Canada after April 1st, 2002):
Saline-Filled Breast Implants: Style 68HP, 68MP, 68LP, 163, 268, 363LF, 468
Gel-Filled Breast Implants: Style 10, 15, 20, 40, 25, 110, 115, 120, 410, INSPIRA®
Patients will be covered by the warranty if the implants have been implanted according to Natrelle®’s directions for use by a qualified/licensed surgeon using proper surgical techniques. The warranty provides patients with a replacement implant in the case of a loss of shell integrity causing rupture requiring surgical treatment.
The Natrelle® warranty does not cover adverse reactions (other than implant rupture), implant removal due to wrinkling, rippling and/or capsular contracture or aesthetic/size dissatisfaction. The warranty does not cover any of the costs that may arise from implant replacement surgery, unless the rupture occurs within the first 10 years.
Under the Allergan ConfidencePlus® Warranty, when a qualifying replacement surgery occurs within 10 years from the date of implantation, Allergan will pay out-of-pocket expenses for surgical fees, operating room, and anesthesia expenses directly related to revision surgery and not covered by insurance, up to a maximum aggregate amount of $1,200.