J&J Creed Promises High Quality as Pelvic Mesh Complaints Come In
This coverage is provided in conjunction with We Are Mesh Survivors, a coalition of synthetic vaginal mesh implant survivors united to demand justice for those who have suffered and to demand that existing products be pulled from the market until their safety can be demonstrated.##
Jo Huskey was an active women. She enjoyed hiking with her husband and dogs and would use her elliptical machine to stay fit. She had lost about 50 pounds and actually made fitness her profession, working as a physical therapy assistant. She had a good marriage with her second husband, Allen, who would join her in their hikes with the couple’s two dogs.
A little urine leakage was not part of her active lifestyle so in January 2011 she consulted with physician Dr. Gretchen Byrkit, an Ob/Gyn. Byrkit had been schooled in placing the TVT-O by her office partner, Dr. Darin Rominger and together they would work to place the polypropylene medical devices. Together they implanted Mrs Huskey in February 2011.
The first witness of the morning in this day three of Huskey v. Ethicon was Dr. Sohail Siddique, a urogynecologist and professor of Ob/Gyn at Southern Illinois University. When Dr. Byrkit could not deal with the complications of pain in her patient she referred Mrs. Huskey to Dr. Siddique.
“There are reports of pain with movement with the obturator sling” he said during his deposition shown to the jury via videotape. Huskey had firm, inflamed tissue on either side of her groin where the mesh was exposed.
“Bacteria will grow on the mesh and try to spread to surrounding tissue. That’s what I believe happened to her,” he said.
In a November 2011 mesh removal, Dr. Siddique explanted a portion of the mesh that was lying in support of the urethra. With the partial excision of mesh, the pain was not resolved.
“Removal of mesh may not remove the pain,” he said adding that any time you operate there can be nerve damage and that can cause permanent pain.
Her next treatment was a series of injections containing steroid with a numbing agent. After three sets of injections, the doctor did not see his patient anymore. “I don’t know what happened to her” he said.
Meng Chen is a medical doctor, schooled in Beijing, China who began working for Ethicon in March, 2006.
She was a witness for the defense, but in this third day of trial, the plaintiffs’ showed her testimony via videotape.
Part of her job was to monitor complaints that came into J&J concerning its pelvic meshes. There was no trend noted in the complaints involving TVT products, she said. There was no trend regarding dyspareunia complaints either even though pain with sex didn’t appear in the IFU, she said. The Instructions for Use (IFU) are supposed to contain all of the information an implanting doctor would need to know about a device before instructing a patient on the benefits versus risks.
Dr. Chen was asked to recite the Johnson & Johnson creed which she did with compliant employee perfection: First, everything the company does must be of high quality for mothers, fathers and patients. Second, J&J must be responsible to our communities and employees and not to be forgotten, its shareholders.
Chen testified she didn’t know how many reports of dyspareunia she would have to take into her New Jersey office to signal a problematic trend. “We cannot assume all of the cases of dyspareunia are caused by the TVT product,” she said.
How many cases would have to come in before it would “pop up?”
“I don’t know,” she answered.
Dyspareunia or painful sex does not appear in the TVT line of products IFU. Do you believe the IFU should reflect the current knowledge of potential adverse reactions?
“How do you define current?
What they knew at the time, if there is information not reflected in the old IFU should the new be updated to provide more current or newer information?
“A company should make the best effort to capture as current the information as possible but not necessarily in real time.”
Dr. Chen said erosion is caused by the implantation of any foreign material in the pelvic region and is complicated by multiple factors such as weak pelvic floor tissues, obesity, surgery and smoking.
Is dyspareunia a known adverse event of TVT products?
“You don’t think dyspareunia is a known adverse event of TVT products?
“I do not think I’m equipped to give a definitive answer to that.”
But in a database kept by the company, reports were coming in from women who had received TVT implants, of mesh erosion, extrusion and exposure, known as the “Three E’s”. Incontinence would reoccur and pain was noted which affected the women’s quality of life.
Dr. Chen said she was so concerned she spoke up and a meeting in January 2009 between regulatory and medical affairs of Ethicon, the division of Johnson & Johnson responsible for the TVT pelvic meshes.
She heard the stories. Women were calling her New Jersey office saying their experience did not meet the expectations they had been promised in the product label.
“I did see every day that the patient reports contained their description of their experience are not transitory at all.”
But a trend analysis was never done because, according to Dr. Chen, “that’s not what the process required.” #