Medical studies have shown that the vaginal
mesh popularly used by gynecologists to repair pelvic organ prolapse (POP such
as cystocele or urethrocele) or treat urinary incontinence has huge evidence of
serious complications. Unfortunately, even many doctors today don’t understand
the complications of erosion of the mesh through the vagina.
Any surgical mesh used to repair stress
urinary incontinence (SUI) or pelvic organ prolapse (POP) is at a risk of
erosion, failure, and the need for repair. These devices used the 510(k)
clearance to get the FDA approval without testing. Soon enough after their
introduction to the market, the devices started showing up some serious
complications. Some of the most severe symptoms reported in the mesh lawsuit update include the
following such as:
- the mesh eroding through the bladder, vagina and bowel
- recurring infections
- vaginal scarring, or erosion of the vaginal tissue
- recurrence of uterine prolapsed and vaginal prolapsed
- urinary problems such as incontinence
- pain during intercourse (medically called dyspareunia)
What steps has the FDA taken?
On October 2008, the FDA issued a Public
Health Notification addressing the healthcare practitioners alerting them of
the health issues linked with the transvaginal placement of surgical mesh. The agency had received over 1,000 reports of
complications arising from the use of TVM and that the most frequent
complications included issues such as erosion through vaginal epithelium,
urinary problems, infection, pain, and recurrence of prolapse and/or
incontinence.
On July 2011, the FDA issued a safety
communication update highlighting serious complications associated with the
surgical mesh for transvaginal repair of POP are not rare. Growing number of
evidence and review of scientific literature had shown that ‘’transvaginal public organ prolapse repair
with mesh does not improve symptomatic results or quality of life over
traditional non-mesh repair.’’
Class action or personal lawsuit?
As the medical device manufacturers’ failed
to adequately explore the potential risks and complications associated meshes,
the victims might be eligible for damage awards in terms of financial
compensation. Patients can file for either a vaginal mesh lawsuit or class
action claim.
What are the main issues in the mesh lawsuit
update?
- Using wrong and misleading information to showcase the safety and efficiency of the mesh devices to the U.S. Food and Drug Administration, the medical community, and patients about the true safety and effectiveness of the products.
- Did not properly conduct any study and research on the devices
- Failed to inform about the risk and complications
- No safe known procedure for the mesh removal
The transvaginal sling lawyers at TVM411.info
are providing free consultations and
claim evaluations for those who have
experienced complications following the surgery to repair POP or SUI.
All consultations are confidential with the experts of TVM411.info and after reviewing a
potential lawsuit, there is no
obligation to hire their law firm. You do
not have to pay any attorney fees
unless you obtain the compensation.
Visit : tvm411.info
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