Brigette Honaker ย |ย  August 5, 2019

Category: Legal News

Though bladder mesh is not designed to be removed, it may need to be extracted if mesh complications set in.

What is Transvaginal Mesh?

Transvaginal mesh, sometimes called pelvic mesh or bladder mash, is a net shaped implant used to hold up pelvic organs. In women with urinary incontinence or pelvic organ prolapse, where the pelvic floor cannot support the organs, pelvic mesh may be implanted to hold up the bladder and uterus. The implanted mesh forms a โ€œslingโ€ under these organs to help take pressure off the pelvic floor and relieve symptoms.

Can Bladder Mesh Be Removed?

Like other mesh products, including hernia mesh, pelvic mesh is not designed to be removed. Surgeons will typically only remove transvaginal mesh if patients are suffering from transvaginal mesh problems.

According to UCLA Health, 13 percent of patients who are implanted with pelvic mesh will require a repeat operation within five years of their initial surgery. In total, around 30 percent of patients will require revision surgery in their lifetime.

What Are Possible Pelvic Mesh Complications?

Several complications may be possible
with pelvic mesh, including:

  • Pain: Women have reported chronic pelvic pain, groin pain, hip pain, and pain during intercourse.
  • Incontinence: Although pelvic mesh is used to treat incontinence, failure of the mesh can result in a return of incontinence symptoms.
  • Mesh erosion: After the mesh is implanted, the product may be eroded away by friction or pressure.
  • Exposure: Vaginal mesh or components of the implant may be displayed, revealed, exhibited, or accessible when they should not be.
  • Extrusion: Parts of the mesh can protrude out of the tissue. For transvaginal mesh, this may be seen with portions of the mesh protruding into the vagina.
  • Perforation: In some cases, the bladder can become perforated by pelvic mesh. This results in a small hole that can lead to further complications.

Some complications may be so severe that they necessitate revision surgery. These are the cases that require mesh removal.

In 2016, the U.S. Food and Drug Administration (FDA) recognized the high risk of transvaginal surgical mesh and implemented the strictest requirements for these products. As a result of the increased approval requirements, the FDA reports that โ€œall manufacturers stopped marketing surgical mesh intended for transvaginal repair of posterior compartment prolapse.โ€

In 2019, the FDA took further action by ordering manufacturers to stop selling transvaginal mesh products. The agency made this decision due to the numerous complications possible with the mesh products.

โ€œBased on the review of available evidence, the FDA believes that the benefit-risk profile of mesh placed transabdominally to treat [pelvic organ prolapse] and mesh used to treat [stress urinary incontinence] remains favorable,โ€ the FDA reports. โ€œHowever, we continue to review new evidence as it becomes available.โ€

Can I Take Legal Action If I Needed My Pelvic Mesh Removed?

Numerous manufacturers have faced legal action regarding pelvic mesh complications. The following manufacturers and their products are involved in litigation:

  • C.R. Bard: Avaulta, Align, Biosynthetic Support System, CollaMend, Pelvilace, Pelvitex, Ugytex, Pelvicol and Uretex
  • Boston Scientific: Arise, Advantage, Lynx, Obtryx, Pinnacle, Prefyx, Polyform, Solyx
  • American Medical Systems: SPARC, BioArc, Elevate, Mini-Arc, Perigee
  • Coloplast: Exair, Axis, Restorelle Smartmesh, Novasilk, Susped
  • Caldera Medical: Desara, Ascend, Vertessa
  • Ethicon: Gynecare Prolift, Gynecare TVT, Gynecare Prosima
  • Mentor: Obtape Transobturator Sling
  • Neomedic International: Needleless System, TRT Remeex System, KIM System

Do YOU have a legal claim? Fill out the form on this page now for a free, immediate, and confidential case evaluation. The transvaginal mesh attorneys who work with Top Class Actions will contact you if you qualify to let you know if an individual lawsuit or class action lawsuit is best for you. [In general, transvaginal mesh lawsuits are filed individually by each plaintiff and are not class actions.] Hurry โ€” statutes of limitations may apply.

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