DCCKKA026483
Dow Corning Wright
PO Box 100
Arlington TN 38002
November 26, 1991
George J. Picha, MD, PhD
Medical Arts Center
6681 Ridge Road, Suite 406
Parma, OH 44129
Dear George:
Thank you for both your letters concerning your thoughts as a result of the FDA Panel hearings and your
request for finalizing the agreement with DCW involving tissue expanders and adjusted relationships involving the mammary
implant.
I am sure you understand the situation here is chaotic. This is a result of our strong belief that
we have only achieved an interim respite at the Panel hearings. The outcome give Kessler a wide choice for his final decision.
We do not want him to remove the product from the market in any sense, and establish it as an IDE product. Such a classification
would cause havoc for surgeons, as well as manufacturers as the result of patients feeling they have been deceived.
In light of this, I do not believe it is wise to finalize the words on the agreement until we know the January
6 outcome. At that time, we will want to rapidly move forward to bring your contract to conclusion. I do not like
the fact that we've had to keep it open as long as we have, but I feel it has been the most prudent thing to do given the
uncertainty we are faced with.
With respect to your commentary regarding your interest in being able to help take forward some of the research
projects involving mammary implants and the materials involved, I believe a person in an academic surrounding is certainly
a strong possibiliy to provide support to the progress of such programs. Switching materials, however, is not high on
our list. We are in the middle of trying to discuss with the FDA what they expect to achieve and by when. Right
now, we are trying to put our minds together on all the specific studies which need to be finalized. Certainly, your
commentary on several of the specific studies you are interested in appear to be appropriate in terms of the need for the
data. We will be facgtoring this into our thinking as we move forward and will keep you apprised. If either of us have
additional comments on this during the interim, let's try to respond as we move forward.
Thank you for all the help and support in Washington. I believe you have identified the critical issue.
I agree completely that it is an entirely new product we are dealing with in terms of perceptions. If you sit back
and think about implant products that are put in the human body, all of them are in the thousands of dollars type pricing
categories. The ability to simply look at the breast implants from a manufacturing cost point of view is no longer valid
and the whole basis for pricing is going to have to be reexamined. The thought that the silicone breast implant can
be in the human body upwards to 75 years is a very challenging subject.
I hope you and your family have a great Thanksgiving holiday. I look forward to seeing you and working
with you as we move through this challenging time.
Best regards,
Dan M Hayes, Jr.
President and CEO
DMH:lch
