Valeant Pharmaceuticals And IDEAL IMPLANT Announce FDA And Health Canada Approval To Market Ideal Implant For Cosmetic Breast Augmentation
LAVAL, Quebec, Nov. 18, 2014 /PRNewswire/ -- Valeant Pharmaceuticals International, Inc. (NYSE: VRX) (TSX: VRX) and Ideal Implant Incorporated today announced the receipt of approval from the U.S. Food and Drug Administration (FDA) and Health Canada to market the IDEAL IMPLANT® Saline-filled Breast Implant for use in primary breast augmentation or replacement of existing augmentation implants. The FDA approval of the IDEAL IMPLANT was based on an extensive review of various studies and data including a U.S. clinical trial that began in 2009 with 45 plastic surgeons and 502 women, who underwent breast augmentation or replacement of augmentation implants. The clinical trial is on-going and will continue to provide follow-up data through 2020.
"For years, patients have been asking for a breast implant that offers the natural feel of silicone gel with the safety of saline," according to Larry S. Nichter, M.D., M.S., F.A.C.S. "The IDEAL IMPLANT effectively addresses that need with an internal structure that allows this saline implant to achieve the look and feel of natural breasts. The use of only saline with the IDEAL IMPLANT technology eliminates the potential concern of silent ruptures that require MRI monitoring for detection."
Women interested in seeking a consultation about the IDEAL IMPLANT can locate the surgeons who will have initial access to it by visiting the IDEAL IMPLANT website at www.idealimplant.com.
Important Safety Information about Ideal Implant Saline-filled Breast Implant
The IDEAL IMPLANT Saline-filled Breast Implant is indicated for women at least 18 years old for primary breast augmentation to increase breast size. Potential adverse events that may occur with saline-filled breast implant surgery include: deflation, capsular contracture, reoperation, implant removal, pain, changes in nipple and breast sensation, infection, scarring, asymmetry, wrinkling, implant displacement/migration, implant palpability/visibility, breastfeeding complications, hematoma/seroma, implant extrusion, necrosis, delayed would healing, breast tissue atrophy/chest wall deformity, calcium deposits, and lymphadenopathy.
Breast implant surgery is contraindicated in women with existing breast cancer or pre-cancer, women with active infections or who are currently pregnant or nursing. The IDEAL IMPLANT has not been studied for use in breast reconstruction.
About Valeant Pharmaceuticals International, Inc.
Valeant Pharmaceuticals International, Inc. (NYSE/TSX: VRX) is a multinational specialty pharmaceutical company that develops, manufactures and markets a broad range of pharmaceutical products primarily in the areas of dermatology, eye health, neurology and branded generics. More information about Valeant can be found at www.valeant.com.
Forward-looking Statements
This press release may contain forward-looking statements, including, but not limited to, statements regarding on-going clinical trials and providing follow-up data through 2020. Forward-looking statements may be identified by the use of the words "anticipates," "expects," "intends," "plans," "should," "could," "would," "may," "will," "believes," "estimates," "potential," or "continue" and variations or similar expressions. These statements are based upon the current expectations and beliefs of management and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. These risks and uncertainties include, but are not limited to, risks and uncertainties discussed in the company's most recent annual or quarterly report filed with the Securities and Exchange Commission ("SEC") and other risks and uncertainties detailed from time to time in the Company's filings with the SEC and the Canadian Securities Administrators, which factors are incorporated herein by reference. Readers are cautioned not to place undue reliance on any of these forward-looking statements. Valeant undertakes no obligation to update any of these forward-looking statements to reflect events or circumstances after the date of this press release or to reflect actual outcomes.
Contact Information:
Laurie W. Little
Valeant Pharmaceuticals International, Inc.
949-461-6002
[email protected]
Sara Skirboll/Stacey Miyamoto
CMMPR for Ideal Implant Incorporated
(212) 979-8884
[email protected] or [email protected]
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SOURCE Valeant Pharmaceuticals International
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