Transvaginal Mesh Problems
HARMFUL RISKS LINKED TO SURGICAL MESH IMPLANTS: NEARLY 5,500 REPORTS OF COMPLICATIONS FILED WITH THE FDA
If you recently received a transvaginal mesh implant as a treatment for pelvic organ prolapse (POP) or stress urinary incontinence (SUI) and suffered mesh erosion, contact our experienced female surgical mesh lawsuit attorney (former registered nurse) to discuss fully the risks associated with the procedure.
In a 2011 FDA report on surgical mesh implants it was noted that serious complications are not rare and may expose patients to greater risk. Mesh erosion is a serious medical complication where the synthetic transvaginal mesh gradually moves through the pelvic wall and sometimes into other organs.
The Food and Drug Administration (FDA) issued a warning against using synthetic mesh as a treatment for pelvic organ prolapse, saying that the surgical mesh implants have been linked to the following complications:
- Mesh erosion
- Increased infection risk
- Urinary complications
- Bowel, bladder and blood vessel perforations
- Additional pelvic organ prolapse
- Sexual complications.
Many women with surgical mesh implants have required multiple revision surgeries trying to remove the surgical mesh implant. Many claims are being settled now and time may be limited to file a claim. If you have experienced problems with receiving a surgical mesh implant or if you have required revision surgery to try to remove the transvaginal mesh implant you may be entitled to financial compensation.
Our female mesh attorneys are experienced in the complications and risks associated with transvaginal mesh. We understand the sensitive nature of discussing symptoms and are available immediately for a free and confidential case review.
Fill out the form on this page for a simple no obligation legal review with a former female registered nurse turned attorney to discuss the health risk. You could be entitled to significant compensation for the suffering you and your family have endured. Act now or risk losing your rights all together.
WHY WAS THE SURGICAL MESH IMPLANT USED AT ALL?
The transvaginal mesh procedure has been used to repair pelvic organ prolapse, which happens when the pelvic organs become dislodged from their proper location. The connective vaginal tissue is stitched back into place, repairing the dislodgement between the vaginal wall and muscle.
Common procedures used include transvaginal mesh slings and the transvaginal tape system, which have been found to deteriorate, causing mesh erosion, infections, urinary incontinence, and abdominal pain.
Mesh is a permanent synthetic material that has been widely used in surgical procedures most commonly for hernia repair treatments. The mesh is intended to provide a netting of support material to help repair the tissue tearing that occurred during the pelvic organ prolapse.
The varying degrees of the severity of the prolapse dictate how much mesh is needed to repair the damaged tissues. Prior to the FDA warning, vaginal mesh prolapse surgery was considered relatively safe with few risks.
An alternative to the vaginal mesh surgery is the vaginal pessary for prolapse procedure which involves the installation of a pessary device which supports the vagina. As an alternative to vaginal prolapse surgery, the pessaries have proven successful, though the pessaries require replacing every 3 to 6 months.
A vaginal prolapse is a condition most commonly diagnosed through the symptoms of constipation, bowel emptying problems, bladder problems, sexual intercourse problems or by the discovery of a vaginal lump. The symptoms are caused by the pelvic organs, namely, the bladder, uterus and/or bowel protruding into the vagina.
HISTORY OF TRANSVAGINAL MESH PRODUCTS
Transvaginal mesh products were first cleared by the FDA for use in 1996. The first was introduced by Boston Scientific called the ProteGen vaginal sling for treating stress urinary incontinence. Later, FDA approval was provided for a number of other surgical mesh implant products. Johnson & Johnson released the Gynecare TVT vaginal mesh sling, and another soon followed.
According to the American Journal of Obstetrics & Gynecology (AJOG report), the ProteGen Sling, “turned out to have an extremely high erosion rate within 8 months of implantation,” and among the community of pelvic surgeons, stories of infections, ulcers and eroded slings spread. The initial surgical mesh implant was later recalled in 1999 by Boston Scientific, but related products from other manufacturers were still being used.
Adding further insult to injury, the very approval process of the FDA was called into question in a Bloomberg piece, when complaints revealed a similar J&J product and other companies’ pelvic mesh medical products were approved by the Food and Drug Administration based on their similarity to the ProteGen even following its recall and amidst safety complaints.
The FDA got caught with their pants down,” said Thomas Margolis, a pelvic surgeon in Burlingame, California.
The floodgates were open as victims of injuries caused by pelvic mesh slings began filing lawsuits in pursuit of compensation against manufacturers, most notably Johnson & Johnson and Boston Scientific. The transvaginal mesh cases were consolidated in February 2012, and all federal cases were ordered consolidated into four MDL proceedings, naming: C.R. Bard; American Medical Systems; Boston Scientific, and Ethicon.
GET HELP FILING A TRANSVAGINAL MESH LAWSUIT
If you suffered complications after a transvaginal mesh surgery, you may be entitled to compensation to cover your medical expenses as well as for your pain and suffering.
It is important to act quickly when filing a transvaginal mesh lawsuit as regulations limit the amount of time victims of complications have to report a claim and pursue legal recourse.