The vaginal mesh helpline is keeping women updated .J & J called for a Global discontinuation for their vaginal Mesh products. Vaginal Mesh helpline feels this is a wonderful development . Atleast some of the J & J surgical mesh devices won't be on the market hurting more women. That still does not help the thousands of women suffering.
Johnson and Johnson (J&J) recently announced that they would end sales of versions of surgical mesh products that were used to decrease the intensive pelvic discomfort of women; the decision was made following a number of complaints as well as reports of injuries and deaths.
The surgical mesh products in question are implanted in women to help improve damaged or weakened vaginal wall tissue and to offer support for those who had pelvic organ prolapse (POP). POP is diagnosed in patients where the tissue holding the pelvic is weak, becoming stretchy and weak in the vagina. Prolapse can occur in patients who have undergone childbirth, menopause, or a hysterectomy. The mesh was also used to assist those with stress urinary incontinence, which is a condition with a severe overactive bladder. Mesh has also been used for bladder and bowel prolapse.
On Tuesday, June 5, J&J spokesman Matthew Johnson stated that the company asked the U.S. Food and Drug Administration (FDA) if they could stop the sales of four related products within the next 120 days. This time period would allow hospitals and surgeons to find suitable alternatives. The product liability litigation is currently overseen by Judge Carol Higbee of New Jersey Superior Court in Atlantic City and federal Judge Joseph Goodwin of the U.S. District Court for the Southern District of West Virginia, including lawsuits involving Boston Scientific Corp and C R Bard Inc.
On Monday, June 4, the Ethicon division of J&J sent a letter to Higbee and Goodwin describing the request the company had made to the FDA regarding the discontinued sale of the mesh products. J&J also asked that the requirements for other studies on Gynecare products be suspended. Previously in January, the FDA had requested more studies be done on the vaginal mesh products.
“Ethicon has no present intention to commercialize these products in the future,” the company commented in a letter described in a Reuters article.
According to the FDA, in 2010 7,500 females had mesh repairs for POP and around 200,000 patients had transvaginal repairs for stress urinary incontinence. The FDA also stated that there were more than 1,500 cases that reported malfunction with the mesh between 2008 to 2010, including situations where the mesh eroded into the vagina or caused internal bleeding and infection. In recent years, people have sued the device makers of the surgical mesh products, alleging organ damage and other similar injuries due to the devices. There are currently thousands of lawsuits pending against Ethicon.
Over the next three to nine months, J&J has stated that it will discontinue sales of the products like Gynecare Prolift Pelvic Floor Repair System, Gynecare TVT Secur System, and Gynecare Prosima Pelvic Floor Repair System on a region-to-region basis in its global markets. The company will end sales as a result of negative publicity about the vaginal mesh devices and not due to the lawsuits.
“This is not a recall; it’s a global discontinuation,” Johnson said.
The decision by J&J could also be due to the company’s desire to prevent more lawsuits against vaginal mesh devices. Gynacare may have been the easiest one to drop from a purely business vantage point.
“I think the timing of everything is going to make it very hard for them to convince the jury that they don’t believe safety isn’t tied to their decision (to discontinue),” J. G. who is representing some of the women suing the mesh makers, noted in the Reuters article. “(And) from our perspective, this is a fantastic development … We’re happy (the surgical mesh devices) won’t be on the market and hurting more women.”
According to the Wall Street Journal, the decision to cut the surgical mesh products, sold under J&J’s Ethicon unit, follows actions taken on other problematic products. The products that have had manufacturing problems include the bottle caps of children’s Tylenol and other over-the-counter medication, as well as DePuy hip replacement implants.
Four vaginal mesh implant products .
Ethicon markets five different vaginal mesh products, and sales of four models –
Prolift, Prolift+ M, TVT Secur and Prosima – will be ended on a region-by-region basis by the first quarter of 2013. The fifth product – Gynemesh – will remain on the market for abdominal implantations only, with revised labeling to indicate its restricted use.
This news highlights the fact that the pressure hundreds of lawsuits filed by women across the country has forced the first multi-national corporation to acknowledge the problem and stop hurting more women. Ultimately, the actions of woman who come forward and file suit will continue to have a very significant effect on the other manufactures of vaginal mesh, and help prevent thousands of additional women from being injured.
Instances of vaginal mesh failure continue to occur in the over 75,000 woman who have received the procedure. If you've been injured as a result of a defective vaginal mesh implant, please contact us as soon as possible to discuss your case and learn how the law can work for you. Remember the stautes are running close in many states. We do not want you to be left out.
Source: redOrbit (http://s.tt/1dtl1)
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