FDA allows Mentor Corp to remove "follow up" requirement

Ilena Rosenthal and the Humantics Foundation finds this "back
stepping" a very dangerous "amendment." In past Mentor studies, as few
as 5% follow up had been reported.

www.BreastImplantAwareness.org


Mentor Announces Amendment to Its MemoryGel(TM) Breast Implants
Post-Approval Study Protocol

http://digital50.com/news/items/BW/2...val-study.html

SANTA BARBARA, Calif.-(Business Wire)-May 3, 2007 - 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(TM) 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.