Manufacturers of the Gynecare ProLift Transvaginal Mesh System Face Plaintiffs and Scientists
Earlier in January, Linda Gross’s lawsuit against Johnson & Johnson subsidiary Ethicon went forward in court. The plaintiff had a transvaginal mesh device made by Ethicon implanted to help prevent pelvic organ prolapse in 2006, and since then has had 18 revision surgeries, and continues to suffer chronic pain and mesh erosion.
This lawsuit is the first of thousands of lawsuits against Johnson & Johnson/Ethicon, alleging that the company knew the dangerous side effects of transvaginal mesh, and chose to market the product anyway.
Linda Gross is one of the first in a series of bellwether trials in the multidistrict litigation specifically against Ethicon. Five other MDLs against five other transvaginal mesh manufacturers are also, slowly, scheduling bellwether trials and heading to court.
The next transvaginal mesh cases will be the trial cases in re: C.R. Bard, Inc., Pelvic Repair Systems Products Liability Litigation (MDL No. 2187). They will begin on February 5, 2013 according to the status conference report.
In the trial of Gross v. Gynecare, Dr. Piet Hinoul, a worldwide medical director for Ethicon, testified about the transvaginal mesh devices manufactured by the subsidiary. He claimed that, as of 2005, Ethicon was discussing how to create a safer transvaginal mesh, even though the Prolift had not yet hit American markets.
In his testimony, Hinoul admitted that Ethicon’s key opinion leaders and developers told the company as early as 2004 that the Prolift transvaginal mesh was too heavy, needed larger pores, was causing too much “bridging fibrosis” and was prone to shrinkage and contraction. Because of these problems with the first version of the mesh, side effects can include pain with sex, loss of sexual function and high rates of erosion into other organs like the bladder and surrounding muscles. Hinoul testified that Ethicon knew of these painful side effects before the Prolift was released.
Transvaginal Mesh Clinical Trials Underway as Bellwether Cases Move Forward in Court
Transvaginal mesh implants are finally receiving thorough clinical trials, as lawsuits head to court.
The clinical trial is recruiting participants in the US and Germany, to check the reliability and safety of transvaginal mesh products, from an unbiased perspective. Researchers from the Mayo Clinic and American Medical Systems (a manufacturer of a transvaginal mesh product which has its own MDL) are collaborating on the clinical trial.
Not only will the clinical trial test the safety of transvaginal mesh products, it will also compare the devices to another procedure often used to correct pelvic organ prolapse – the suture procedure.
This clinical trial is scheduled for completion by December 2015. Similar clinical trials have been performed in the past, including one published in The New England Journal of Medicine. It concluded, in part, that mesh repair “resulted in higher short-term rates of successful treatment but also in higher rates of surgical complications and postoperative adverse events.”
The FDA summarized common complications as follows: “From 2008-2010, the most frequent complications reported to the FDA for surgical mesh devices for POP repair include mesh erosion through the vagina (also called exposure, extrusion or protrusion), pain, infection, bleeding, pain during sexual intercourse (dyspareunia), organ perforation, and urinary problems. There were also reports of recurrent prolapse, neuro-muscular problems, vaginal scarring/shrinkage, and emotional problems. Many of these complications require additional intervention, including medical or surgical treatment and hospitalization.”
In the meantime, Ethicon pulled several transvaginal mesh devices from the market in June 2012. The manufacturer admitted to no defects in the product, and they did not offer reimbursement to customers. Instead, Ethicon claimed that the voluntary recall was due to low sales figures.
The Strom Law Firm Can Help with Transvaginal Mesh Personal Injury Cases
If you or a loved one have had surgery involving transvaginal mesh, and have since suffered painful side effects including bleeding, infection, organ perforation, and constant pain in the lower extremities, you may be entitled to compensation. The attorneys at the Strom Law Firm understand the suffering caused by defective devices like transvaginal mesh, and can help with your case. We offer free, confidential consultations to discuss your concerns, so do not hesitate to contact us. 803.252.4800.