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Transvaginal Mesh

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The Device
 

Transvaginal slings and meshes are medical devices used to treat both pelvic organ prolapse (POP) and stress urinary incontinence (SUI).  Both SUI and POP occur with advancing age, child birth, and pregnancy; and both are associated with weakened musculature in the pelvic region, resulting in an inability to properly support internal organs.  As a result, symptoms arise such as the inability to properly control bladder function, pain, discomfort, and the extrusion of internal organs into and/or from the vaginal entrance.  The lifetime risk of undergoing an operation to treat POP or SUI by the age of 80 is estimated to be around 11.8%, and currently there are over 200,000 surgeries performed annually for POP. [i]

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Tim Goss discusses the $1.2 Million Batiste Jury Verdict for a Mesh Sling


Manufacturers pushed for the development of transvaginal mesh in part as a response to the low success rate of traditional surgical treatments for POP and SUI known as colpopexy, or colporrhaphy.  These surgical techniques involve surgically cutting and stitching areas of weakened connective tissues.  Success rates for these standard surgical treatments are low, and typically require revision and/or additional surgery on the same area in about 40% of cases.[ii]   As a result, device manufactures looked to other areas of medicine for potential devices capable of treating POP and SUI, ultimately settling on synthetic and biological meshes which had exhibited success in treating, among other complications, hernias.  Unfortunately for many patients, the FDA has recently stated that it is no longer “clear that transvaginal POP repair with mesh is more effective than traditional non-mesh repair in all patients with POP and it may expose patients to greater risk.”[iii]

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The Controversy

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Transvaginal mesh was approved for use by the FDA based on the 510(k) approval process, which requires a showing of substantial similarity to previously approved devices.  As such, the FDA required little to no safety testing for the approval and marketing of transvaginal mesh.  Manufacturers have lauded the use of transvaginal mesh as an alternative method of treating POP and SUI using a minimally invasive procedure, without the need of trimming the vagina or suturing mesh to the vagina.  While methodology using transvaginal mesh has exhibited a higher success rate (i.e. a lower failure rate) compared to colpopexy and colporrhaphy, failure rates are still relatively high.  For example, researchers report the need for additional surgery as upwards of 30%,[iv] depending on the device, procedure, and affected anatomical area.[v]

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Of greater concern than the rate of failure is the introduction of adverse events specific only to the use of transvaginal mesh.  For example, in 2005, researchers out of Germany and Switzerland reported over 15% of patients experience mesh erosion and exposure.[vi]  In 2006, Mentor Corp. became the first manufacturer to pull a vaginal sling device, OBTape, from the market.  Specifically, after only three years on the market, it was apparent the device was defective as it failed to account for the necessity of allowing nutrients and oxygen to flow through the device and into the woman.  Due to these complications and others, the FDA issued a bulletin in 2008 warning surgeons and patients of potential safety concerns, based on both published findings, and over 1,000 adverse events reported to the FDA’s adverse event reporting system between 2005-2007.[vii]

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On July 13 2011, the FDA issued a follow-up to their 2008 warning intended to further underscore the risks of transvaginal mesh.[viii]  Specifically, the FDA is now reporting that adverse events previously denoted as being rare, are now being recognized as not rare.  For example, between 2008-2010, an additional 2,874 adverse event reports were submitted to the FDA.  Of the adverse events, the most common and consistent complication was erosion, which often requires multiple surgeries to repair, can be debilitating in some women, and in some cases, further surgery fails to correct the initial problem.  Finally, erosion can result in additional problems for male partners who may experience irritation and pain to the penis during intercourse due to mesh exposure.

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In addition to erosion, the FDA warns of additional complications.  For instance, mesh contraction (shrinkage) is now known as a predominant complication often associated with severe pelvic pain, pain during intercourse, and/or an inability to engage in intercourse.  Additionally, the FDA and independent research has exhibited perforation of the bladder, blood vessels, and/or bowels occurs in around 3.5% of surgeries.[ix]  Finally, the complications such as infection, pain, bleeding, pain during intercourse (dyspareunia), urinary problems, recurrent prolapse, vaginal scarring/shrinkage, neuro-muscular problems, and emotional problems have all been observed.

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As transvaginal mesh was approved by the FDA with little to no safety testing, only requiring a showing of substantial similarity to previously approved products, little is known about the long-term safety and effectiveness of these devices.  As a result, many surgeons and medical experts have gone on record in their respective peer-reviewed journals to state that these devices should be treated as experimental, and that informed consent (i.e. giving the patient all material information about the products risks and benefits) is impossible given the lack of medical evidence regarding the “risks, benefits, and overall safety and efficacy…sufficient to regard them as established medical practice.”[x]  Still other researchers have gone even further, suggesting that “until adequate effectiveness and safety evidence is available, the use of new TVM devices for prolapse repair should be considered experimental and restricted to use in investigative trials.”[xi] In response, the FDA Obstetrics-Gynecology Devices Panel will convene in early September 2011 to discuss and make recommendations regarding the safety and effectiveness of these devices.

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Complications and Symptoms

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  • Mesh erosion and exposure through the vaginal wall

  • Pain

  • Urinary problems

  • Recurrence of prolapse

  • Recurrence of incontinence

  • Infection

  • Pain during sexual intercourse

  • Inability to engage in intercourse

  • Vaginal scarring and/or shrinkage

  • Bladder, bowel, or blood vessel perforation

 

Manufacturers and Devices

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  • Johnson & Johnson®

    • Ethicon® TVT

    • Gynecare® TVT

    • Gynecare® Prosima

    • Gynecare® Prolift

    • Gynemesh® PS

  • Boston Scientific®

    • Advantage™ Sling System

    • Obtryx® Curved Single

    • Obtryx® Mesh Sling

    • Prefyx Mid U™ Mesh Sling System

    • Prefyx PPS™ System

    • Arise®

    • Lynx®

    • Pinnacle®

    • Solyx®

  • C.R. Bard

    • Avaulta Plus™ Biosynthetic Support

    • Avaulta Solo™ Synthetic Support

    • Faslata™ Allograft

    • Pelvicol® Tissue

    • PelviSoft® Biomesh

    • Pelvitex™ Polypropylene Mesh

    • Avaulta Plus™ Biosynthetic Support

    • Avaulta Solo™ Synthetic Support

    • Faslata™ Allograft

    • Pelvicol® Tissue

    • PelviSoft® Biomesh

    • Pelvitex™ Polypropylene Mesh

  • American Medical Systems

    • Sparc®

    • MiniArc®

    • Monarc®

    • In-Fast®

    • BioArc®

    • Elevate®

    • Perigree®

    • Apogee®

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If you or a loved one have suffered from any side effects from transvaginal mesh, get a free case evaluation. Attorneys are available by phone (1-877-519-7216) e-mail (claims@mymeshclaim.com), or by submitting the free case evaluation form.

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[i] Alex Gomelsky et al., Pelvic Organ Prolapse (POP) Surgery: The Evidence for the Repairs, 107 BJUI 1704-19 (2011).

[ii] See R. Beck et al., 25-Year Experience with 519 Anterior Colporrhaphy Procedures, 78 Obstetrics and Gynecology 1011-18 (1991).

[iii] FDA Alert, FDA Safety Communication: UPDATE on Serious Complications Associated with Transvaginal Placement of Surgical Mesh for Pelvic Organ Prolapse, July 13, 2011.

[iv] C Elmer, Trocar-Guided Transvaginal Mesh Repair of Pelvic Organ Prolapse, 113 Obstetrics and Gynecology 117-26 (2009).

[v] See Jens-Erik Walter et al., Transvaginal Mesh Procedures for Pelvic Organ Prolapse, 33(2) Journal of Obstetrics and Gynaecology Canada 168-74 (2011).

[vi] Kaven Baessler et al., Severe Mesh Complications Following Intravaginal Slingplasty, 106(4) Obstetrics and Gynecology 713-16 (2005).

[vii] FDA Public Health Notification: Serious Complications Associated with Transvaginal Placement of Surgical Mesh in Repair of Pelvic Organ Prolapse and Stress Urinary Incontinence, October 20, 2008.

[viii] FDA Alert, FDA Safety Communication: UPDATE on Serious Complications Associated with Transvaginal Placement of Surgical Mesh for Pelvic Organ Prolapse, July 13, 2011.

[ix] Daniel Altman, Anterior Colporrhaphy versus Transvaginal Mesh for Pelvic-Organ Prolapse, 364(19) New England Journal of Medicine 1826 (2011).

[x] Anne Weber, Letters to the Editors: Informed Consent cannot be Obtained for Use of Vaginal Mesh, American Journal of Obstetrics & Gynecology e6 (2011).

[xi] Jens-Erik Walter et. al., Transvaginal Mesh Procedures for Pelvic Organ Prolapse, 33(2) Journal of Obstetrics and Gynaecology Canada 168-74 (2011).

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