Dateline: Miami, Florida Patients Advocate Lana Keeton, Founder and President of Truth in Medicine, scored a victory in court. Ms. Keeton won a verdict against defendant, Dr. Bernard Cantor, a Miami doctor, for medical negligence. The victory is a first in a lawsuit involving the Johnson & Johnson Gynecare TVT Prolene synthetic surgical mesh. Ms. Keeton underwent a hysterectomy and bladder suspension in December 2001 that almost ended her life.
Successfully treated for a necrotizing soft tissue infection at Jackson Memorial Hospital, following the initial surgery performed at Mt Sinai Medical Center on Miami Beach by Dr. Bernard Cantor, Ms. Keeton spent several months recuperating. Her experience has made her a formidable force in advocating for other injured patients.
Testifying at trial, Ms. Keeton stated she was not given proper informed consent for the implantation of the mesh. Dr. Cantor’s description to Ms. Keeton of the Prolene synthetic surgical mesh was simply “It’s a new tape. You will really like it.” No mention was made of the fact that the “tape” was a permanently placed medical device which cannot be removed without significant damage to tissue once implanted in the body. Nor did Dr. Cantor tell Ms. Keeton the product could be improperly implanted during the procedure or could erode (move by itself within the body) to cause permanent irreversible complications which she suffers. Dr. Cantor also omitted his lack of experience in the performing the procedure and complications in patients he had operated on prior to Ms. Keeton which required re-operation of the patient.
Ms. Keeton and Mr. James Shull, the Vice President of Truth in Medicine, were instrumental in getting the FDA to issue a Public Health Notification warning doctors and patients of the serious risks and complications of trans-vaginal placement of synthetic surgical mesh in October 2008. Based on their work, many law firms began filing lawsuits on behalf of other patients permanently harmed by synthetic mesh.
In an e-mail to a Truth in Medicine member in September 2009, Dr. Bobby Shull, Professor of Obstetrics and Gynecology, Dept Obstetrics and Gynecology, Texas A&M’s Scott & White Clinic in Temple, Texas says:
“Personally, I am pleased there is a patient advocacy group who is involved in helping us learn more about these products. My feeling is we will look back on this time with a sense of ‘why did anyone ever convince women to be subjected to these treatments?’ when little real information existed on the risks to be assumed.
There are other examples in gynecology; the Dalkon Shield for example or earlier sub-urethral slings…Protegen is one. Other products have been removed from the market only after a number of women were found to have been harmed.
It is unfortunate that women are and have been harmed. Perhaps with your group's influence the current situation can be changed for the sake of all the other women who are yet to be treated.”
Truth in Medicine’s primary initiative to achieve its’ mission is an Informed Consent Project with the University of Miami’s Bioethics Department headed by Kenneth W. Goodman, PhD. The focus is to create a comprehensive Informed Consent Tool Kit website for medical devices, the first being for synthetic surgical mesh. This would significantly lower the cost and increase the quality of healthcare.
Ms. Keeton notes the proliferation of synthetic surgical mesh “kits” have emboldened surgeons lacking the requisite surgical skills to do operations that have bad outcomes for the patients because, among other things, they do not know how to deal with the complications.
Ms. Keeton says, “The victory over Dr. Bernard Cantor signifies a big step forward in stopping future harm of other patients.”