Mesh Medical Device News Desk, January 9, 2020 ~ A product liability pelvic mesh trial naming Johnson & Johnson began this Monday in US District Court in Miami for the first pelvic mesh not implanted transvaginally to treat stress urinary incontinence.
Charlotte Salinero of Miami and her husband, Efran, filed the action on September 6, 2018 (US District Court, Southern District Florida Case No. 1:18-cv-23643-UU).
She underwent implantation of Ethicon’s Artisyn Mesh during a sacrocolpopexy surgery to treat uterovaginal prolapse in December 2012. Her surgeon, Dr. Jaime Sepulveda-Toro from South Miami Hospital, performed a robotic sacrocolpopexy.
Image: Judge Ursula Ungaro, US So Fl District Court
By April 24, 2017, Salinero had a lengthy removal surgery included eroded pieces that had traveled to the bladder, colon and vagina. Drs Supelveda-Toro, Dr. Marcos Szomstein, and Dr. John Mekras, (gynecologist, urologist and colorectal surgeon) teamed up to perform the low anterior resection with diverting loop ileostomy due to a rectovaginal fistula, which was removed.
The case is being tried before Judge Ursula Ungaro of the US District Court for the Southern District of Florida.
Courtroom sources say the jury is made up of six females and four males with a few women in their thirties and the remainder middle age.
Salinero is represented at trial by The Ferraro Law Firm of Miami.
The defendant corporations, Ethicon Inc. of Somerville, New Jersey and Ethicon, LLC, a wholly owned subsidiary of Johnson & Johnson Medical Inc., located in San Lorenzo, Puerto Rico, are represented by Butler Snow, Goldman Ismail Tomaselli Brennan and Baum, and Squire Patton Boggs.
Salinero alleges catastrophic and permanent damages including, but not limited to, mesh erosion and contraction, infection, fistula formation, inflammation, scar tissue, organ perforation, dyspareunia, urinary problems, blood loss nerve damage and pain, shortening of the vagina pelvic floor damage, chronic pelvic pain, incontinence, prolapse, economic loss and lost income.
The plaintiff is suing based on Negligence, strict liability-Manufacturing defect, Failure to warn, defective product, design defect, Common Law Fraud, Fraudulent concealment, Constructive Fraud, Negligent Misrepresentation, Negligent Infliction of Emotional Distress, Breach of Express Warranty, Breach of Implied Warranty, Violation of Consumer Protection Laws, Gross negligence, Unjust Enrichment, Loss of Consortium, and punitive damages.
Evidence concerning the Food and Drug Administration’s lackluster regulation of medical devices will not be allowed to be presented to the jurors.
Artisyn, made of Prolene mesh, Johnson & Johnson’s proprietary name for its polypropylene (PP) mesh, is used to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI).
It is a “Y” shaped polypropylene mesh that helps attach the top of a collapsing vaginal vault, as a sort of bridging material during a sacrocolposuspension/sacrolpopexy procedure.
This is the first case of a mesh implanted robotically for sacrocolpopexy which is typically an open procedure using a 6-8 cm up to 15 cm horizontal incisions in the lower abdomen to access the organs. Sacrocolpopexy involves the top of the vagina (vaginal vault) or the cervix that have dropped out of normal position.
The symptoms of a fallen uterus can include bulge or even a protrusion from the vaginal canal making it difficult to have sexual relations, to urinate or even have a bowel movement.
According to Deborah Kotz of the FDA, the Y-shape mesh is still marketed for the treatment of POP. Beside Artisyn, other meshes placed abdominally include Upsylon Y mesh, made by Boston Scientific, and the Restorelle Y shape. These can be placed robotically or laparoscopically.
These POP meshes are placed through an abdominal surgery and are considered a moderate risk, Class II medical devices. They therefore do not have to go through premarket approval and clinical trials as mandated in the up-classification of transvaginal POP mesh by the FDA in 2016.
A surgeon can still choose a sheet of polypropylene mesh and cut her own mesh implant for an abdominal POP implant. Sheets of mesh, the same mesh used for hernia repair, are still Class II and available on the market.
The mesh in question made by Ethicon is Artisyn Y Shaped 27 CM x 5 cm.
According to the complaint, the Defendant had a “legal duty to insure the safety and effectiveness of their Mesh Products by conducting adequate and well controlled studies on their products prior to marketing.”
Instead, Ethicon (JNJ) chose to “manipulate the only studies that were conducted on their products” therefore doctors and patients were presented with false and misleading information on safety and effectiveness.
Ethicon made a conscious decision to forego performing studies and create registries that would have provided doctors and patients with accurate information.
Defendants are liable to Plaintiffs for damages due to design, manufacture, marketing, labeling, distribution, sale and placement of defective mesh products even though they know they are not safe.
The plaintiff is suing based on Negligence, Strict Liability-Manufacturing defect, Failure to warn, defective product, design defect, Common Law Fraud, Fraudulent concealment, Constructive Fraud, Negligent Misrepresentation, Negligent Infliction of Emotional Distress, Breach of Express Warranty, Breach of Implied Warranty, Violation of Consumer Protection Laws, Gross negligence, Unjust Enrichment, Loss of Consortium, and punitive damages.
Dr. M. Tom Margolis is expected to take the stand for the plaintiff early next week. Dr. Margolis has been an expert for injured women and believes the mesh had no place in a woman’s body. He likens its removal to taking gum out of hair. Dr. Margolis also testified at the Food and Drug Administration’s 2011 expert panel hearing.
While Dr. Margolis is a familiar face in pelvic mesh defective mesh trials, this is the first case that has tested whether an abdominal placement of pelvic mesh delivers the same complications as a transvaginal placement (through the vagina).
Abdominal sacrocolpopexy is considered the gold standard for the treatment of POP and is generally considered safe. Most trials so far have focused on the transvaginal implant process but using mesh kits for POP repair dropped substantially after the 2011 FDA warning that said complications were “not rare” but increasingly there are problems with sacrocolpopexy including prolapse recurring in the back wall by the rectum. Pain, mesh exposure and damage to bladder, bowel or ureters are reported.
The American Urogynecology Society, a group of urogynecologists (AUGS) reports it has a high success rate of 80 percent, though the polypropylene (PP) material remains the same with a complete of complications including, but not limited to, mesh erosion, migration, infection, pain and autoimmune reactions.
The trial is predicted to last two weeks.
MND, April 16, 2019, FDA Orders Mesh Makers to Stop Selling Prolapse Mesh
MND, April 17, 2019 Pelvic Mesh Remains on the Market Despite FDA Decision