Transvaginal mesh products are sometimes used to repair stress urinary incontinence (SUI) and pelvic organ prolapse (POP), conditions that can often occur following childbirth or as a patient ages. Despite how commonplace the use of mesh products in these procedures became following their introduction, both in the US market and globally, patients soon began to experience severe, devastating complications.
Complications from mesh include nerve damage and chronic pain, vaginal scarring and shrinkage resulting from the erosion of the mesh inside of the body and cases of organ perforation where the implants became exposed inside the patient’s vaginas. The implants have even been linked to several deaths.
Researchers have struggled to determine how often these issues occur, current estimates lie between 15% and 25%. What is clear is that when complications do arise they are often severe and life-limiting, far more so than the original condition they were intended to treat.
While mesh implants for POP have been the most heavily targeted by regulators, implants for SUI have not come under the same scrutiny. Neither have mesh implants for conditions where the product is implanted abdominally rather than transvaginally, via incisions made in the vagina.
Drugwatch senior writer Michelle Llamas says: “The FDA and doctors agree that placing mesh through the abdomen has fewer risks. There are a few studies that suggest there is no difference in the complication rate. Mesh used for SUI is also deemed safe.”
Different international laws also mean that reparations for patients suffering from complications resulting from their mesh have taken very different forms from country to country. In Britain, for example, cases have not been successfully brought directly against device manufacturers, but rather against the NHS Trusts that performed the procedures, as a result of the way the Consumer Protection Act 1987 is interpreted in UK courts.
Lime Solicitors legal director Peter Kelly says: “For successful action against device manufacturers under product liability law, you have to show that the safety of the product is not such as persons generally are entitled to expect. It’s the interpretation of that part of the legislation which has proven most difficult.
“In a clinical negligence case you just have to show that either that the actual operation to insert the mesh device was negligently performed, or – as in virtually all of the cases I’ve had – the patient was not properly warned of the risks inherent in the mesh operation.”
But, how did mesh implants go from modern marvel to a medical menace?
1996 – 2002: Mesh implants are formally introduced in the US
The US Food and Drug Administration (FDA) cleared the first mesh implant for SUI, Boston Scientific’s ProteGen Sling, in 1996. The first mesh for POP was approved in 2002.
Boston Scientific recalled the ProteGen Sling in 1999 as a result of patient complications, but not before several additional products were approved on the basis that they mimicked ProteGen Sling’s design through the FDA’s 501(k) procedure. The 501(k) is a premarket submission to be issued to the FDA which demonstrates that the device is substantially equivalent to another legally marketed device.
After these initial launches, more and more mesh products were developed worldwide and pushed onto the market.
2008 – 2011: FDA issues its first warnings
In 2008, the FDA released a Public Health Notification and Additional Patient Information on serious complications associated with surgical mesh placed transvaginally to treat SUI and POP.
A later safety communication was issued about the use of mesh specifically for POP in 2011. The FDA noted that serious complications associated with these procedures were not rare, and that mesh surgeries did not alleviate patients’ symptoms any more than non-mesh procedures.
2012 – 2013: The first vaginal mesh lawsuits go to trial
C.R. Bard (Bard) withdrew its Avaulta Plus vaginal mesh from the market in July 2012, weeks before losing a $3.6m verdict to a woman who experienced complications from the device.
Johnson & Johnson (J&J) lost the first federal mesh lawsuit in February 2013, with American Medical Systems (AMS) becoming the first company to agree to a large settlement in July 2013. Bard lost the second federal lawsuit involving transvaginal mesh less than a month later.
January 2016: Mesh, reclassified
The FDA reclassified urogynaecological surgical mesh from a class II to class III device, requiring the submission of a 501(k) for the devices. As a result of the FDA’s actions, all manufacturers stopped marketing surgical mesh intended for transvaginal repair of posterior compartment prolapse.
July 2017: Major case against J&J begins in Australia
A trial against J&J involving 700 Australian patients began in federal court. The company was accused of improperly testing the devices and downplaying their risks to both surgeons and patients. The pharmaceutical giant was accused of selling the devices as easy to implant, despite them being highly complex and only suitable for skilled and experienced surgeons.
November 2017: Australia bans transvaginal mesh for POP
Australia’s Therapeutic Goods Administration said the risk to patients using mesh to treat POP outweighed the benefits, and quietly banned the use of the devices for this procedure.
December 2017: New Zealand bans all transvaginal mesh procedures
New Zealand’s Ministry of Health followed suit and restricted the use of all pelvic mesh. It is still the only country to do so for both POP and SUI.
December 2017: Media and research controversy in Britain
A review published in the British Medical Journal revealed that 61 manufacturers sold mesh without clinical trials, with safety and effectiveness evidence shown to be weak.
In the same month, BBC Panorama, revealed that Ethicon has failed to properly warn UK doctors of the risks associated with transvaginal mesh and had inadequately tested its kits before selling them. The investigation claimed that Ethicon’s TVT-Secur implant, which was taken off the market in 2012, was available for commercial purchase after being tested on only 31 women for five weeks, and in sheep.
May 2018: Boston Scientific lands itself in hot water
A report by 60 Minutes revealed that Boston Scientific used untested counterfeit Marlex plastic in its mesh products. In 2005, the company’s plastic supplier, Chevron Phillips, said it would no longer provide the material to make mesh over concerns that it was unsuitable for implantation in the human body, telling the device maker: “We are simply not interested in this business at any price.”
Boston Scientific instead found a counterfeit Marlex supplier in China to continue the production of its mesh products. The Chinese supplier provided an inferior product to the already questionable original, with experts informing 60 Minutes that the mesh now lasted only a few months.
July 2018 – April 2019: British Government halts sale of vaginal mesh, then reinstates it
The UK Department of Health and NHS England accepted recommendations from Baroness Cumberlege that mesh implants could not be considered safe until certain conditions are met in July 2018. The conditions were that surgeons should only perform the surgeries if they were properly trained and performed them regularly, while a review recommended the creation of a registry on the devices to track complications as they occur.
Come April 2019, the British National Institute of Health and Care Excellence (NICE) declared that mesh implants could once again be offered by the NHS in England if Cumberlege’s guidelines were followed. However, the NHS is not obligated to act on NICE’s guidelines and a ‘pause’ on these surgeries remains in place.
17 April 2019: Transvaginal mesh for POP banned in the US
Manufacturers of surgical mesh products intended for transvaginal repair of anterior compartment prolapse were ordered to stop selling and distributing their products immediately. Therefore, there are currently no FDA-approved surgical mesh products for transvaginal repair of POP which can be legally implanted in the US.
25 April 2019: J&J ordered to pay $120m in damages to US patient
A Philadelphia court ordered J&J to pay $120m in damages to Susan McFarland, who underwent surgery to fit the TVT-O transvaginal mesh implant in 2008 to treat SUI. It is the biggest payout issued to an individual patient to date.
October 2019: J&J agrees to pay $117m to settle nationwide mesh lawsuits in US
J&J and its subsidiary Ethicon agreed to a $117m multi-state settlement over allegations of deceptively marketed transvaginal surgical mesh products. A total of 41 states, as well as the District of Columbia, settled. An investigation carried out by the states found that J&J and Ethicon misrepresented the safety and effectiveness of the surgical mesh devices, as well as inadequately disclosing the risks related to the products.