Mentor Announces Amendment to Its MemoryGel™ Breast Implants Post-Approval Study Protocol
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Mentor Announces Amendment to Its MemoryGel™ Breast Implants Post-Approval Study Protocol
SANTA BARBARA, Calif.--(BUSINESS WIRE)--Mentor Corporation (NYSE:MNT), a leading supplier of medical products for the global aesthetic market, announced today that it has received approval from the U.S. Food and Drug Administration for an amendment to the Company's MemoryGel™ silicone gel-filled breast implant post-approval study (PAS) protocol. The PAS protocol amendment addresses patient enrollment.
Responding to questions and feedback from a number of Institutional Review Boards (IRB) and physicians concerning the restriction of patient access to an approved device, the FDA has approved Mentor's amendment to the PAS protocol to a voluntary patient enrollment design. This change will allow those patients who choose not to or cannot participate in Mentor’s PAS the opportunity of selecting Mentor’s MemoryGel implants for their surgery. Mentor will continue with the mandatory requirement for physicians by only allowing access to Mentor's MemoryGel implants to those physicians who agree to participate in the PAS, who have or are seeking IRB approval, and who actively encourage their patients to participate in the PAS.
The development of both Mentor’s post-approval study design as well as the physician and patient enrollment approaches was an extremely involved process that took place over many months prior to FDA’s approval of Mentor’s MemoryGel breast implants, with post-approval conditions, on November 17, 2006. The confidential nature of this regulatory process did not permit detailed input from the clinical community regarding the PAS protocol. During the early market introduction of the MemoryGel breast implants, Mentor has benefited greatly from practical feedback from physicians and IRBs alike, which resulted in Mentor submitting a premarket approval application supplement for an amendment to the PAS protocol.
As of May 2, Mentor reported that it has received IRB approvals for approximately 2,600 participating physicians in 5,000 surgical facilities, with approximately another 750 physicians awaiting IRB approval. In addition, Mentor has enrolled close to 4,000 patients into the PAS. Mentor is fully committed to the PAS and will continue to work closely with its physicians and with FDA to monitor the study’s progress through to completion.
About Mentor Corporation
Founded in 1969, Mentor Corporation is a leading supplier of medical products for the global aesthetic market. The Company develops, manufactures and markets innovative, science-based products for surgical and non-surgical medical procedures that allow patients to retain a more youthful appearance and improve personal well-being. The Company's website is www.mentorcorp.com.
Safe Harbor Statement
This press release contains forward-looking statements regarding certain FDA regulatory actions, including approval of an amendment to Mentor’s MemoryGel breast implants post-approval study protocol. These forward-looking statements are based on our current expectations, estimates and projections about our industry, management's beliefs and certain assumptions made by us. Any statements that refer to expectations, projections or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking statements. These forward-looking statements speak only as of the date hereof and are based upon the information available to us at this time. Such information is subject to change, and we will not necessarily inform you of such changes. These statements are not guarantees of future results and are subject to risks, uncertainties and assumptions that are difficult to predict. Therefore, our actual results could differ materially and adversely from those expressed in any forward-looking statement as a result of various factors.
The Securities and Exchange Commission filings of Mentor, including, without limitation, its Annual Report on Form 10-K, its Quarterly Reports on Form 10-Q, and recent Current Reports on Form 8-K, discuss important risk factors that could contribute to such differences or otherwise affect its business, results of operations and financial condition. Mentor undertakes no obligation to revise or update publicly any forward-looking statement for any reason.
About the Author
Mentor Corporation
Loren L. McFarland, Chief Financial Officer
805-879-6082
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