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Trial testimony cites high failure rates in company prototype as first of hundreds of cases is heard
San Diego CA (PRWEB) February 07, 2013
Resource4thePeople announced today that as testimony continues in one of the first trials involving claims of defects in transvaginal mesh it is continuing to provide referrals for victims of failed mesh systems to lawyers offering free consultations.
These consultations can provide legal options to victims who may have suffered health problems caused by mesh failures after surgeries to treat two health problems caused by women as they age: pelvic organ prolapse (POP) and urinary incontinence.
These referrals by Resource4thePeople continue as a trial is underway in Atlantic City, New Jersey in which pharmaceutical giant Johnson & Johnson and subsidiary Ethicon are defending themselves against a lawsuit claiming that one of the company’s transvaginal mesh products was defective.*
Resource4thePeople also is informing consumers that transvaginal mesh products have been the subject of Safety Communications issued by the Food and Drug Administration warning of “serious complications associated with transvaginal placement of surgical mesh for pelvic organ prolapse.**
In the warning issued to health care professionals, the FDA cited recent medical literature which revealed that:
The FDA said that its literature review found that erosion of mesh through the vagina is the most common and consistently reported mesh-related complication from transvaginal POP surgeries using mesh.
Agency officials said mesh erosion can require multiple surgeries to repair and can be debilitating for some women. In some cases, even multiple surgeries will not resolve the complication.
The FDA also said that mesh contraction (shrinkage) is a previously unidentified risk of transvaginal POP repair with mesh that has been reported in the published scientific literature and in adverse event reports to the FDA since an earlier mesh warning issued on Oct. 20, 2008. Reports in the literature associate mesh contraction with vaginal shortening, vaginal tightening and vaginal pain.
“Both mesh erosion and mesh contraction may lead to severe pelvic pain, painful sexual intercourse or an inability to engage in sexual intercourse, the FDA said in the warning. “Also, men may experience irritation and pain to the penis during sexual intercourse when the mesh is exposed in mesh erosion.”
The New Jersey trial involves a lawsuit by a 47-year-old South Dakota woman who had a Gynecare Prolift implanted in her body in 2006 and claims to have suffered such severe damage to her abdominal organs that she has since had to undergo 18 operations to repair her body.
The woman is seeking damages against Johnson & Johnson and Ethicon over allegations that the transvaginal mesh product was not adequately tested before being put on the marketplace and that the company’s were aware of dangerous health risks but failed to warn consumers.
Resource4thePeople also is recommending that patients who have had transvaginal mesh implants that have failed monitor the progress of the trial, which is being covered by major media such as Bloomberg News.
Bloomberg reported on Jan. 11, 2013 that “a prototype of a Johnson & Johnson (JNJ) vaginal mesh implant failed in 20 percent of women within six months even before the device was first sold in 2005, a company official testified today in Atlantic City, New Jersey.”***
“The company also found that 27 percent of the devices failed within a year, said Scott Ciarrocca, a project leader for the development of the device for J&J’s Ethicon unit. French researchers had reviewed 87 women who received the type of implant that Ethicon developed into its Gynecare Prolift.
“Ciarrocca was the first witness at the state court trial of a lawsuit by Linda Gross, 47, who claims J&J sold a defective vaginal mesh implant after testing it inadequately and failing to warn of all the risks. The case by Gross, a nurse from South Dakota, is the first of 1,800 such lawsuits to go to trial.
“Gross’s attorney, Adam Slater, asked Ciarrocca about the failure, or recurrence, rate while trying to show that Ethicon never adequately studied the risks of the device, which helps shore up pelvic muscles.
“The studies seem to indicate that after six months, they had a recurrence rate of more than 20 percent,” Ciarrocca told jurors today.”
The FDA says pelvic organ prolapse occurs when the tissues that hold the pelvic organs in place become weak or stretched. Thirty to fifty percent of women may experience POP in their lifetime with 2 percent developing symptoms.
When POP happens, the organs bulge (prolapse) into the vagina and sometimes prolapse past the vaginal opening. More than one pelvic organ can prolapse at the same time.
Organs that can be involved in POP include the bladder, the uterus, the rectum, the top of the vagina (vaginal apex) after a hysterectomy, and the bowel.
In the case of stress urinary incontinence, the FDA said there is a leakage of urine during moments of physical activity, such as coughing, sneezing, laughing, or exercise.
According to the Bloomberg News report Johnson & Johnson has discontinued sales of four mesh devices in the U.S., including the Prolift.
The company said in June that it would end sales worldwide based on the products’ commercial viability, not their safety and effectiveness, according to Bloomberg.
*Gross v. Gynecare Inc., Atl-L-6966-10, Superior Court of Atlantic County, New Jersey (Atlantic City)
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