In early November, 1992, Tobias Meeker, Director of Ethics Program of St. John’s Hospital in Springfield, Missouri, sent an 8-page fax to the ASPRS. The documents included an internal St. John’s memo and a letter to David Kessler of the FDA concerning some serious reservations about the protocols of the Phase II Mentor study of silicone gel implants allowed by the FDA.

"The protocol did not appear to be a ‘research study’ in any familiar sense of that term...inclusion criteria are very subjective and general. The consent form omitted a good deal of information that we believed should be revealed. In one section we found an outright error (when compared to information given in the protocol itself)."

Tobias Meeker contacted a doctor at the FDA for clarification, and was told "...breast implants were grandfathered in. That means they were ‘unapproved but legally marketed’...‘It is an administrative device to continue to make these devices widely available to those who have such need that the lack of established safety can be overlooked if there is a good informed consent process and the oversight of an IRC.’" An IRC is an Institutional Review Committee. St. John’s quotes Joyce Denny, adjunct study coordinator at Mentor, who said "that the consent form had been ‘negotiated’ between Mentor and the FDA and could not be changed."

St. John’s ethics review indicated that "...This makes these devices widely available on the one hand and, on the other hand, calls into question the validity of data that will be collected...many will share the subcommittee’s concern that the very subjective determination of ‘medical need’ opens the door for conflict of interest by researchers and that it is irresponsible to widely disseminate these untested devices. St. John’s will appear irresponsible if the IRC reviews and approves this protocol...Our IRC met 9/25. One of the surgeons who hopes to do these procedures met with us. The discussion was lively. The surgeon gave his understanding that this protocol was designed ‘to give the illusion of a study’ so that these devices could remain on the market...We unanimously agreed that this protocol does not meet criteria that we normally expect of a clinical study."

In the letter to David Kessler from Meeker it was stated, "We realize that many plastic surgeons have firm convictions that the silicone poses no health risk. We respect their convictions, but point out that wrong convictions do not constitute scientific evidence."

Note that the Mentor Study to be released soon will have Garry Brody as one of its key contributors, as he is now a consultant for Mentor, the only remaining breast implant manufacturer. In a letter dated November 12, 1992, to the Journal of the American Medical Association, Brody says of women with breast implants, "The real cause of delayed detection of breast cancer in the augmented patient appears to be the same four horsemen of the apocalypse that are responsible for delay in all women; i.e., denial, neglect, complacency, and ignorance."

The following documents were used in preparing this article:

ASP034217-34227

ASP034214-34216

and a copy of the Washington Edition of the Los Angeles Times 06/26/97