Transvaginal mesh is a surgical mesh used to treat problems in women such as 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.
There are many different types of transvaginal mesh products, as listed below. Two of the largest vaginal mesh manufacturers are Johnson & Johnson/Gynecare and Bard. In 2002, the FDA approved transvaginal mesh to help reinforce or to better secure the organs.
In 2011, the FDA announced that nearly 3,000 complications associated with transvaginal mesh had been reported. The most common complications include:
- Mesh erosion and exposure through the vaginal wall
- Infection
- Pain
- Dyspareunia (pain during sexual intercourse)
- Bleeding
- Urinary problems
- Organ perforation
- Recurrence of prolapse
- Recurrence of incontinence
- Inability to engage in intercourse
- Vaginal scarring and/or shrinkage
- Bladder, bowel, or blood vessel perforation
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”
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% depending on the device, procedure, and affected anatomical area.
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. 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.
On July 13 2011, the FDA issued a follow-up to their 2008 warning intended to further underscore the risks of transvaginal mesh. 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.
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. 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.
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.” 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.” 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.
Manufacturers and Devices
- 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®
If you or a loved one suffered complications following transvaginal mesh implant surgery, please contact The D’Onofrio Firm at 215.923.1056, at once, for a free consultation with one of our attorneys.