The list of smoking guns continues to grow: (Just a snippet from the documents obtained by the ABC)
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Sent: Mon, 09 Feb 2009 17:50:40 GMT
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Subject: PROSIMA Feedback
I'll provide an overview of the comments I heard at the Summit regarding PROSIMA.
- Unanimously, every surgeon I spoke with told us we were making a huge mistake by commercializing
PROSIMA. As I would dig into the feedback, there were several speci?c areas of concern:
-- We shouldn't focus on applying mesh to a stage 2 defect because the future of these repairs is unknown
We shouldn't be training less skilled surgeons or surgeons with lower surgical volumes especially in light of
the FDA PHN
-- Patients will not tolerate the VSD for 21 days, and this will lower patient satisfaction and referral volume
-- Plication has a roughly 30% rate of recurrence, and PROSIMA has a roughly 30% failure rate
Even if we introduce PRO SIMA, we should do so with GYNEMESH
Since PROSIMA doesn't address apical defects, we should wait to launch until we can modify the graft to
address the apex
-- Customers feel like we are making the same mistakes that we made with namely rushing to market
without all the answers
Customers feel like this dissection is very similar to PROLIFT, and if plicators are unwilling to transition to
PROLIFT they probably do not have the skills to carry out this dissection
-- Customers fear that we are opening up the pool of unquali?ed surgeons to the use of mesh
-?made a good point indicating that we should delay launching this device until we can collect
more info, He recommends expanding the role of the registry to include a subset of doctors that match our
targeting pro?le.
- Salil indicated that he would not use this device in stage 3 prolapse patients
- Several customers indicated that they would like us to package the VSD separately, but they did not anticipate
instructing patients to use this for 3 weeks.
I personally wonder if we should explore physician attitudes about this device outside the US to see if there is
either an expanded role for this as an ex-US device, or if we will have the same concerns globally as we do in
the US. Granted, the PROLIFT users are not our target audience, but if they are not supportive of this device
they have already indicated that they will make a personal effort to ensure that we do not succeed. Several
customers told me they would approach their hospital and try to persuade them not to allow this device to be
used in their hospital. Several customers feel like we should be more focused on apical support, and less
focused on improving stage 2 defects for customers that do not understand how to use mesh.
Given some of the pushback from this in?uential customer base, I'm a little concerned about the backlash this
device could have in the US, speci?cally on our image and our ability to position ?Jture devices. If ever there
was a time to be more conservative, this could be the gut check that we need to take seriously.
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SUBJECT TO STIPULATION AND ORDER OF CONFIDENTIALITY ETH.MESH.OO569126
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