Texas Woman Sues Maker of Surgical Vaginal Mesh Device Due to Serious Injuries

The maker of an implantable vaginal mesh device is being sued by a Texarkana, Texas, woman after the surgery with the device led to her suffering serious injuries.

In a case filed in the Eastern District of Texas, Sally H. York is suing Ethicon Inc., the maker of the Gynecare Prosima Pelvic Floor Repair System, which is an implantable vaginal mesh, according to a story in The Southeast Texas Record.

York’s lawsuit alleges that the Gynecare Prosima vaginal mesh product was defective and worsened the medical condition that she was being treated to correct.

York was originally treated for pelvic organ prolapse, which occurs in women when the cervix, uterus, bladder or other reproductive organs slip down into the vagina due to the weakening of pelvic muscles. Her original diagnosis was made In December 2010 at Christus St. Michael Health System in Texarkana, according to the story.

A medical team conducts a surgical procedure in this stock photo. Image credit: © iStockphoto.com/uchar

A medical team conducts a surgical procedure in this stock photo. Image credit: © iStockphoto.com/uchar

“According to the lawsuit, her medical conditions were not remedied by this procedure but she became physical worse,” the story reported. “York began to suffer from chronic urine leakage and other physical problems.”

The lawsuit charges Ethicon with negligence, breach of warranty for defective design and related charges.

This is an injury that has been becoming all too common in the last few years, and it has led to an increasing number of lawsuits against the makers of other such devices, including C.R. Bard Inc. of Murray Hill, N.J., and Endo Health Solutions Inc. of Chadds Ford, Pa.

In June, consumer goods manufacturer Johnson & Johnson (J&J) announced that it will stop selling four types of surgical mesh implant products. The mesh products had been linked to injuries and triggered about 600 lawsuits against the company. J&J said the products were safe and that its action wasn’t a recall of the products, but just an end to their sales.

In some cases, surgical mesh products that were surgically implanted in women to treat pelvic organ prolapse caused higher rates of pain, bleeding and infection than surgery involving traditional stitches, according to a U.S. Food and Drug Administration (FDA) report. About 75,000 women had this kind of surgery in 2011.

Thirty to fifty percent of women may experience pelvic organ prolapse (POP) in their lifetimes, with two percent developing symptoms, the FDA reported.

In July of 2011, the FDA issued a “safety communication” that reiterated warnings about “serious complications associated with surgical mesh placed through the vagina” to treat the problem. The FDA “identified surgical mesh for transvaginal repair of POP as an area of continuing serious concern.”

The FDA alert also updated an earlier FDA advisory which was issued back in 2008, the agency said. The complications from surgical mesh being used to treat POP “are not rare,” the FDA stated (emphasis added by the FDA).

In a list of recommendations for health care providers, the FDA suggests that they obtain “specialized training for each mesh placement technique, and be aware of the risks of surgical mesh.” The agency also recommends that doctors are “vigilant for potential adverse events from the mesh, especially erosion and infection, as well as “for complications associated with the tools used in transvaginal placement, especially bowel, bladder and blood vessel perforations.”

Another key, the FDA recommends, is that doctors should “recognize that in most cases, POP can be treated successfully without mesh thus avoiding the risk of mesh-related complications.”

The FDA also recommends that patients who suffer adverse effects from the use of the surgical mesh promptly report their case to the agency through MedWatch, the FDA Safety Information and Adverse Event Reporting program.

The FDA has received “more than 1,500 reports of complications related to the mesh from 2008 to 2010, including cases where the it eroded into the vagina or caused bleeding and infection,” according to a story by Reuters. “The rate of problems was five times the rate reported from 2005 to 2007.”

Serious injuries due to defective vaginal mesh products are a real health problem for a growing number of women across the United States. Patients who suffer from the crippling injuries caused by these defective mesh devices need skilled, compassionate and dedicated legal teams to help them recover damages for their injuries, pain and suffering.

We here at MyPhillyLawyer stand ready to assist you with your legal case if you or a loved one is ever seriously injured in a case involving vaginal mesh devices and products anywhere in the United States. We represent the families of victims as well, to ensure that their families receive every penny of damages that they are eligible to receive.

Call MyPhillyLawyer at 215-227-2727 or toll-free at 1-866-920-0352 anytime and our experienced, aggressive team of attorneys and support staff will be there for you and your family every step of the way as we manage your case through the legal system.

When Winning Matters Most, Call MyPhillyLawyer.