Transvaginal Mesh Implant Types
Transvaginal mesh implants have been used in hernia repair since the 1950s. Decades later, surgeons began implanting these devices in patients with pelvic organ prolapse and urinary stress incontinence as well. Once in place, women believed the hammock-like surgical mesh devices would provide them with the added structural support necessary to lead fulfilling lives. However, the thousands of bladder sling lawsuits indicate that something went wrong.
Transvaginal mesh lawyers from The Sanders Firm understand what an embarrassing, costly and stressful experience it can be to need multiple revision surgeries after the first transvaginal mesh implant fails. Seek free legal counsel to find out if you may be entitled to reparations for your suffering. Continue reading to learn about the various types of surgical mesh implants embroiled in federal lawsuits right now.
Types of transvaginal mesh implants
There are many different types of surgical mesh implants that vary by material, design and surgical technique necessary for insertion. Materials for surgical mesh include: non-absorbable polyester or polypropylene, absorbable synthetics, animal tissues and combinations of the aforementioned. The polyester or polypropylene type of mesh is the most popular today.
Different surgical mesh designs include:
- Bladder slings – Strips of mesh that form the shape of a hammock to provide support for the urethra and bladder to keep these organs closed during normal activities, so urine doesn’t leak out.
- Mini slings – A single incision is needed to quickly place a bladder sling that supports the urethra.
- Hernia repair mesh – A small patch is designed to prevent a protruding organ from worsening and allows the body time to heal itself.
- Transvaginal surgical mesh – Generally speaking, this type of mesh can be used in organ prolapse, stress urinary incontinence or hernia repair. It can be made from human, animal or synthetic materials and varies in shape, size and flexibility.
- Mesh tape – This mesh product holds the urethra in a normal position to prevent urine leaks.
Surgical mesh may be implanted using conventional slings that are attached to pelvic tissue with stitches, adjustable slings that are placed in the body while the patient is still awake to make necessary adjustments, or using tension-free slings that require scar tissue formation to remain in place.
The FDA states that the reports of complications associated with transvaginal mesh are not linked to a single brand or model of mesh – but seem to occur across the board as perhaps a shortcoming of the product in general.
Transvaginal mesh implant manufacturers
Manufacturers and brand names of bladder sling and surgical mesh implants include:
- American Medical Systems (Apogee, BioArc, Elevate, Mini-Arc, Monarc, Perigee, SPARC)
- Boston Scientific (Advantage, Arise, Lynx, Obtryx, Pinnacle, Polyform, Prefyx, Solyx)
- Caldera Medical (Ascend, Desara, Vertessa)
- Coloplast (Novasilk, Susped, Exair, Axis, Restorelle, Smartmesh)
- C.R. Bard (Align, Avaulta, CollaMend, Pelvicol, Pelvilace, Pelvitex, Ugytex)
- Ethicon (TVT, Prolene, UltraPro Mesh, Gynecare, Gynemesh, Prosima, Prolift)
- Mentor Corporation (Obtape)
Who are the best candidates for transvaginal mesh implants?
Surgical mesh can be preferable to other types of treatment for organ prolapse, hernia repair and urinary incontinence. Other treatments — like prescription drugs or feminine pads – treat the symptoms of the problem, rather than the root cause. Patients are often advised that a bladder sling or other type of implant can restore anatomy and functionality on a more consistent, permanent basis. This outcome may be true for some people who report reduced pain, shorter hospital stays and reduced rates of recurrence when mesh is used in their hernia repairs or incontinence / prolapse surgeries.
Findings published in the journal Ultrasound in Obstetrics & Gynecology in 2014 indicate that the best candidates for vaginal mesh surgery are women who have a condition called “levator avulsion,” a type of trauma to the pelvic floor muscle sustained during vaginal childbirth. These women are more likely to require the added support of surgical mesh to hold everything in place. In the most recent study, only one of 36 high-risk women needed a secondary surgery a year after receiving a transvaginal mesh implant – compared to 21 of 34 women who underwent a sacrospinous vaginal colpopexy procedure.
Risk factors for complications from transvaginal mesh implants
After investigating adverse events associated with transvaginal mesh, the FDA has made it clear that they believe the risks of surgical mesh for organ prolapse outweigh the benefits.
“We do not see conclusive evidence that using mesh for the transvaginal approach to pelvic organ prolapse improves clinical outcomes anymore than transvaginal procedures that do not use mesh,” said William Maisel, MD, the deputy center director for science at the FDA’s Center for Devices and Radiological Health in Silver Spring, Md. “These devices appear to expose patients to greater risks,” he added.
It’s believed up to a third of women encounter serious surgical mesh complications:
- Bladder spasms
- Bleeding and clotting
- Mesh erosion
- Mesh migration
- Mesh protrusion
- Need for revision surgery
- Organ injury
- Pain during sex
- Painful urination
- Vaginal prolapse
Jane Harrison-Hohner, RN, RNP, writing for WebMD, states that there are known risk factors that can predispose a woman to have mesh erode into vaginal tissues. In a study of 322 women, at-risk candidates included women who were also having a hysterectomy done and smokers. Risk increased with age, implant size and variations in surgical technique. Patients with low estrogen levels were also considered poor candidates for vaginal mesh.
Complications from surgical mesh usually develop in one to four months. Women who had abdominal incisions may not encounter mesh erosion issues until 15.6 months later, however.
Transvaginal mesh implant lawsuits
The massive tide of transvaginal mesh implant lawsuits have been consolidated into eight federal MDLs.
Transvaginal mesh multidistrict litigations:
- MDL 2004: Mentor Corp. (Johnson & Johnson) ObTape Transobturator Sling Products – 551 cases*
- MDL 2187: C.R. Bard Pelvic Repair System Products – 7,096 cases*
- MDL 2325: American Medical Systems (Endo Health) Pelvic Repair System Products – 16,515 cases*
- MDL 2326: Boston Scientific Corp. Pelvic Repair System Products – 9,776 cases*
- MDL 2327: Ethicon (Johnson & Johnson) Pelvic Repair System Products – 14,679 cases*
- MDL 2387: Coloplast Corp. Pelvic Support Systems Products – 1,267 cases*
- MDL 2440: Cook Medical Pelvic Repair System Products – 173 cases*
- MDL 2511: Neomedic Pelvic Repair System: 25*
*Note: Case information is based upon data from the Judicial Panel for Multi-district Litigation as of April 15, 2014.
The plaintiffs in the surgical mesh lawsuits are seeking compensation for past and future medical expenses, lost earnings, loss of consortium, and emotional suffering.
The first surgical mesh lawsuit went to trial in Bakersfield, California in July of 2012. Plaintiff Christine Scott won a jury award of $5.5 million after requiring eight mesh revision surgeries from her C.R. Bard implants. Since then, several other plaintiffs have settled out of court for undisclosed sums.
Transvaginal mesh lawyers at The Sanders Firm are on your side
The Sanders Firm is dedicated to procuring pre-trial settlements and jury awards for plaintiffs who have been harmed by surgical mesh products. With over 45 years of experience in going up against big medical companies, we fight for the little guy. You’ll be treated to a full suite of surgical mesh attorneys, medical consultants and support personnel who will all work to ensure you’re kept in the loop throughout the entire process.
We understand how frustrating it can be to have daily pain, while the medical bills pile up. That’s why our services are free of charge unless we win your case. Call 1-800-FAIR-PLAY any time to discuss your confidential case with a qualified legal professional from The Sanders Firm.
- Huffington Post - Pelvic Mesh Lawsuits: Thousands Of Women Sue Over Surgical Mesh Complications, http://www.huffingtonpost.com/2013/02/08/pelvic-mesh-lawsuits-surgical_n_2647435.html
- Bloomberg – J&J Vaginal Mesh Approved By FDA Based On Older Recalled Device, http://mobile.bloomberg.com/news/2011-10-20/j-j-vaginal-mesh-approved-by-fda-based-on-older-recalled-device?category=%2Fnews%2Fmostread%2F
- Judicial Panel for Multi-District Litigation – April 2014 Pending Dockets, http://www.jpml.uscourts.gov/pending-mdls-0
- Bloomberg -- Bard, Vaginal-Mesh Makers, Said to Be in Settlement Talks, http://www.bloomberg.com/news/2013-09-30/bard-vaginal-mesh-makers-said-to-be-in-settlement-talks.html
- Bloomberg -- Bard, Doctor Ordered to Pay $5.5 Million Over Implant, http://www.bloomberg.com/news/2012-07-24/bard-must-pay-5-5-million-over-vaginal-mesh-implants.html
- FOX News – Jury Awards $3.35 Million In Vaginal Mesh Case Against J&J, http://www.foxnews.com/health/2013/02/26/jury-awards-335-million-in-vaginal-mesh-case-against-johnson-johnson/
- Huffington Post, Adam Wolfberg, M.D.: FDA Says 'No More Mesh' for Hernia Repairs - What Are the Consequences? http://www.huffingtonpost.com/adam-wolfberg-md/fda-mesh_b_897907.html
- U.S. Food and Drug Administration - Urogynecologic surgical mesh implants, http://www.fda.gov/medicaldevices/productsandmedicalprocedures/implantsandprosthetics/urogynsurgicalmesh/
- WebMD – Vaginal Mesh: New FDA Warnings, http://blogs.webmd.com/womens-health/2011/08/vaginal-mesh-new-fda-warnings.html
- FDA – Hernia Surgical Mesh Repair Implants, http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/HerniaSurgicalMesh/default.htm
- Science Daily - Women most likely to benefit from vaginal mesh surgery identified by research, http://www.sciencedaily.com/releases/2014/03/140311101110.htm
- Medicinenet - FDA: Repairing Pelvic Organ Prolapse With Surgical Mesh Risky, http://www.medicinenet.com/script/main/art.asp?articlekey=146908