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Transvaginal Mesh Products Linked to Severe Adverse Health Effects

Posted in Vaginal Mesh

The United States Food and Drug Administration is currently reviewing the safety of transvaginal mesh products manufactured by Bard Medical, American Medical Systems, Boston Science Products, Ethicon, and Coloplast USA.

The FDA comments:

“In the last 3 years, the FDA has received over 1,000 adverse event reports about mesh used in transvaginal surgical repair of pelvic organ prolapse and stress urinary incontinence. These reports include problems such as pain, infection, mesh erosion (into vagina, bowel, and bladder), and recurrence of prolapse or incontinence. Some reports involved rare but serious intraoperative injuries such as bowel, bladder, or blood vessel perforation. Most patients described in the adverse event reports needed medical or surgical intervention, and some required hospitalization.4

Although the exact cause of these adverse events hasn’t been identified, they’re likely to be the result of multiple factors. Further investigation is needed.”[1]

Read the complete FDA statement on the danger of transvaginal mesh products here.

Precautionary measures laid out by the U.S. FDA are as follows:

“Although treatment with mesh may have helped many women, in others it’s caused complications affecting quality of life.3,4 A literature review demonstrates conflicting information on success rates for transvaginal mesh placement, but everyone agrees on the need for controlled trials.5 If you care for a patient undergoing a transvaginal mesh placement procedure, consider this advice:

  • Become familiar with the types of mesh and procedures used for the repair of pelvic organ prolapse and treatment of stress urinary incontinence.
  • Ensure that your patient has given her informed consent. Make sure she’s received appropriate information about her choice of treatment, the type of procedure she’s undergoing, and possible adverse events.
  • During preoperative teaching sessions, tell your patient about possible adverse reactions, the signs and symptoms of infection, and when to notify her healthcare provider.
  • If you’re an OR nurse, follow your facility’s policies and procedures for recording information about implanted materials. Record the name of the mesh used and its catalog number, lot number, and size in the patient’s medical record.
  • Provide your patient with a written copy of the patient labeling from the surgical mesh manufacturer, if it’s available.
  • If your patient has surgery to remove mesh, follow your facility’s policies and procedures for properly handling the explanted mesh. Additionally, follow your facility’s policies and procedures for reporting adverse events.”[2]

So far, the products associated with adverse health effects total 56.  For clarity, I will break them down by manufacturer here:

Bard Medical:

  • The Align Urethral Support System;
  • The Align TO Urethral Support System;
  • The Avaulta Anterior BioSynthetic Support System;
  • The Avaulta Posterior BioSynthetic Support System;
  • The Avaulta Plus Anterior Support System;
  • The Avaulta Plus Posterior Biosynthetic Support System;
  • The Avaulta Solo Anterior Synthetic Support System;
  • The Avaulta Solo Posterior Synthetic Support System;
  • The InnerLace BioUrethral Support System;
  • The Pelvicol Acellular Collagen Matrix;
  • The PelviLace BioUrethral Support System;
  • The PelviLace TO Trans-obturator BioUrethral Support System;
  • The PelviSoft Acellular Collagen BioMesh;
  • The Pelvitex Polypropylene Mesh;
  • The Uretex SUP Purbourethral Sling;
  • The Uretex TO Trans-obturator Urethral Support System;
  • The Uretex TO2 Trans-obturator Urethral Support System; and
  • The Uretex TO3 Trans-obturator Urethral Support System
American Medical Systems:
  • Apogee;
  • Perigee;
  • MiniArc Sling;
  • Monarc Subfascial Hammock;
  • SPARC;
  • In-Fast;
  • BioArc;
  • Elevate;
  • Straight-In;
 Boston Science Products:
  • The Uphold Vaginal Support System;
  • The Pinnacle Pelvic Floor Repair Kit;
  • The Advantage Transvaginal Mid-Urethral Sling System;
  • The Advantage Fit System;
  • The Lynx Suprapubic Mid-Urethral Sling System;
  • The Obtryx Transobturator Mid-Urethral Sling System;
  • The Prefyx PPS System;
  • The Solyx SIS System;
Ethicon:
  • Prolift
  • Prolift +M
  • Gynemesh/Gynemesh PS
  • Prosima
  • TVT
  • TVT-Oturator (TVT-O)
  • TVT-SECUR (TVT-S)
  • TVT-Exact
  • TVT-Abbrevo
Coloplast:
  • T-Sling-Universal Polypropylene Sling;
  • Aris-Transobturator Sling System;
  • Supris-Suprapubic Sling System;
  • Novasilk-Synthetic Flat Mesh;
  • Suspend-Tutoplast Processed Fascia Lata;
  • Exair-Prolapse Repair System;
  • Axis-Tutoplast Processed Dermis;
  • Restorelle;
  • Smartmesh;
  • Omnisure;
  • Minitape;
  • Coloplast Mesh Product(s)

If you or a loved one used a transvaginal mesh product and experienced an adverse health effect, please do not hesitate to contact our team of transvaginal mesh lawyers for a free, no-obligation case consultation.

At your convenience, you may reach our offices by phone at (855) 452-5529 or by e-mail at justinian@dagnerousdrugs.us.  We have the experience, resources, and skills required to secure the justice you deserve.  Call today and see how we can help.


[1] “Tips and Articles on Device Safety > Looking Into Problems with Transvaginal Surgical Mesh” U.S. Food and Drug Administration. U.S. Dept of Health and Human Services. Available at <http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/TipsandArticlesonDeviceSafety/ucm169802.htm> Updated 21 March 2013, Accessed 16 April 2013

[2]Ibid.

[This page updated 10/14/2015 to correct a typographical error regarding Boston Medical.  Boston Medical has no relation to the products described herein.]