| | FDA Warning and Recall: Transvaginal Mesh Patch
FDA WARNING AND RECALL: TRANSVAGINAL MESH PATCH
Defective Transvaginal Mesh Lawyers
Childbirth can create many complications for the mother. Two common conditions after childbirth are Pelvic Organ Prolapse and Stress Urinary Incontinence. Both of these conditions create various complications and symptoms for the mothers. Many products have been introduced by major companies to solve these conditions. One solution has been the creation of the transvaginal mesh patches or slings. However, it has been widely published by the New England Journal of Medicine and now the FDA that these products could be defective leading to many serious complications for patients, including death.
Please find more information below regarding defective transvaginal mesh patches or slings, and the FDA warning associated with their use.
Transvaginal Mesh Patches/Slings and How They Work
When a woman has a child, there is commonly tissue damage, tearing, and other complications inflicted on the abdominal area as a result of labor and delivery. When the tissue damage is left untreated, it can continue to increase the pressure on the bladder and the pressure on the abdominal organs. These are often signs of Pelvic Organ Prolapse and/or Stress Urinary Incontinence.
As stated above, several companies have released transvaginal mesh products onto the marketplace, and some of these companies include:
• American Medical Systems
• Bard
• Boston Scientific
• Ethicon division of Johnson & Johnson
• Gynecare division of Johnson & Johnson
• Johnson & Johnson
If you or a loved one has been a victim of a product made by one of the companies above, you need a transvaginal mesh patch lawyer to represent you and your interests.
Serious Injuries Reported
Defective Transvaginal Mesh patches have caused or led to perforation or puncture of the bladder, intestines and bowels, as well as blood vessels in and around the vaginal wall. The Food and Drug Administration (FDA) reported over 1,000 incidents of potentially fatal complications associated with transvaginal mesh patches.
What Does The Patch Do?
The transvaginal mesh patch is inserted by a doctor and stretched across the vaginal wall, the patch help support internal organs that were once supported by the vaginal wall until a significant stretching, such as during childbirth, may have damaged the tissue.
Dangerous Symptoms and Side Effects of Transvaginal Patches Include:
• Severe bleeding
• Erosion of the vaginal epithelium
• Serious infection
• Return of Pelvic Organ Prolapse (POP)
• Urinary incontinence
Recent Research Indicates Patches' Serious Risks
The New England Journal of Medicine in May, revealed negative side effects associated with the transvaginal mesh patch. The study measured the effectiveness of the patch compared to that of colporrhaphy, the traditional treatment of sticking connective tissue in the vaginal wall back together.
Transvaginal Patch Lawsuits
There are currently 219 cases listed in New Jersey against transvaginal mesh manufacturers, including C.R. Bard Inc. and Johnson & Johnson. These are in addition to the multidistrict litigation of West Virginia filed solely against Bard.
Bard's Avaulta Transvaginal Patch
C.R. Bard Inc. manufactures a family of transvaginal mesh implants. Products include:
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Avaulta Solo Synthetic: polypropylene mesh support without additional products
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Avaulta Plus Biosynthetic: polypropylene mesh with a matrix of cross-linked collagen on one side of the mesh
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Avaulta Biosynthetic: polypropylene mesh with hydrophilic collagen coating (available in a kit for anterior or posterior implantation)
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In October 2010, 88 pending Avaulta lawsuits against Bard were consolidated into a multidistrict litigation in the Southern District of West Virginia. Plaintiffs claim that C.R. Bard was negligent in the products' design and in warning patients about the risk of complications. Additional claims are being pursued against C.R. Bard and other manufacturers of transvaginal patch products.
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Johnson & Johnson Transvaginal Mesh Patch
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The Johnson & Johnson transvaginal mesh patch may cause the injuries listed above. Ethicon, a subsidiary of Johnson & Johnson, manufactures surgical mesh products under the following names that have also been linked to the serious risks:
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Ethicon TVT
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Gynecare TVT
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Gynemesh PS
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Prolene Polypropylene Mesh Patch
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Secur
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Johnson & Johnson and Ethicon have both been named in lawsuits filed by victims claiming the transvaginal mesh implants were defective and led to harmful side effects.
What You Should Do:
First, if suffering severe complications, contact your doctor at once and seek medical attention.
If you are experiencing complications, contact the medical provider or doctor who inserted the patch and ask which manufacturer you have been given and schedule an appointment to see your physician as soon as possible.
Second, if you or a loved one has suffered an injury as a result of the transvaginal mesh patch, please Transvaginal mesh patch attorney immediately at (888) 423-4477 begin_of_the_skype_highlighting (888) 423-4477 end_of_the_skype_highlighting or by filling out a FREE EVALUATION.
Contact us today, there is no obligation. |
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