Transvaginal Mesh FDA Ban and Voluntary Recalls

Transvaginal mesh products used in surgical repair of pelvic organ prolapse (POP) and stress urinary incontinence (SUI) have caused serious injury in thousands of patients. Though large-scale recalls were not issued, the FDA required manufacturers to stop selling transvaginal mesh products in April of 2019.

Quick Summary
Transvaginal Mesh Recalls

After multiple FDA warnings and safety alerts had been issued which resulted in the discontinuation of multiple products, in April of 2019, manufacturers of transvaginal mesh products were ordered to stop selling their devices. Concerns over safety and efficacy of transvaginal mesh had been ongoing for a number of years.

Few transvaginal mesh products have been officially recalled but no products are currently available, and manufacturers will not be allowed to sell or distribute surgical mesh for repair of pelvic organ prolapse or stress urinary incontinence unless the companies can demonstrate safety and effectiveness.

Transvaginal Mesh Side Effects

Transvaginal mesh used for POP and SUI was intended to improve the safety and efficacy of surgical procedures used to repair female urogenital concerns. Many women experienced serious complications and long-term studies have not demonstrated that the use of transvaginal mesh or bladder slings is safer or more effective than non-mesh surgery.

Serious complications of transvaginal mesh have included:

  • Vaginal wall erosion
  • Organ perforation
  • Scar tissue formation
  • Vaginal shrinkage
  • Nerve damage

Transvaginal Mesh FDA Ban and Voluntary Recalls

In April of 2019, the U.S. Food and Drug Administration (FDA) issued a statement regarding the use and sales of urogynecologic surgical mesh implants or transvaginal mesh. The agency …

ordered all manufacturers of surgical mesh intended for transvaginal repair of anterior compartment prolapse (cystocele) to stop selling and distributing their products immediately.”

The FDA further stated that manufacturers …

“have not demonstrated reasonable assurance of safety and effectiveness for these devices, which is the premarket standard that now applies to them since the agency reclassified them into class III (high risk) in 2016.”

Transvaginal Mesh Warnings and Safety Alerts

Surgical mesh has been used since the 1960s for gynecologic and urologic surgical procedures, but the first product marketed for use in transvaginal procedures was not introduced until 1996. It was approved under the FDA’s 510(k) shortcut process which does not require clinical testing for medical devices that are claimed to be similar to other devices already in use.

By 2008, an alarming number of complaints had been reported to the FDA regarding complications caused by vaginal mesh and a safety alert regarding its use was issued. Between 2008 and 2011, the FDA collected more than 3,000 reports of serious adverse events related to the use of transvaginal mesh prompting the issuance of additional warnings.

In 2012, the FDA required manufacturers of 34 POP and 7 SUI mesh products to conduct safety studies for their devices. The agency also conducted an exhaustive literature review, examining documented clinical and anecdotal evidence of comparison of safety and success of POP and SUI procedures where transvaginal mesh was used in comparison to procedures performed without mesh.

This followed prior announcements that showed the FDA’s safety review concluded that when compared to non-mesh procedures, placement of transvaginal mesh in surgical procedures showed:

  • Transvaginal mesh was not always better at treating symptoms or improving quality of life
  • Transvaginal mesh may introduce problems not present in traditional non-mesh surgeries
  • Transvaginal mesh may have greater risks than abdominally transplanted mesh
  • No evidence that using mesh to reinforce the top of the vagina or the back wall of the vagina resulted in better outcome
  • Transvaginal mesh may present a previously unknown risk, called mesh contraction, which in vaginal shortening, vaginal tightening, and vaginal pain
  • Mesh erosion is the most common complication arising from transvaginal mesh surgery to treat POP

In 2016, the FDA required a change to the approval process for transvaginal mesh and began requiring clinical studies for new products, however products already approved may not have been subjected to the same rigorous guidelines. To date, though hundreds of thousands of women may have been harmed or may still be at risk, the FDA did not issue recalls and did not ban the products until 2019. The announcement blocking future sales warned patients to discuss any problems with their physicians.

Notable voluntary recalls of transvaginal mesh products in the past included:

Boston Scientific introduced one of the first transvaginal repair products, which also had some of the highest failure rates. Boston Scientific’s ProtoGen transvaginal mesh was voluntarily recalled in 1999, followed by ObTape’s recall in 2006. These products were replaced by newer versions which have also caused injuries.

C.R. Bard voluntarily recalled and discontinued manufacturing their Avaulta Plus transvaginal mesh in 2012, after a jury awarded more than $5 million to a woman who had been harmed by the device. Bard still manufactures a number of other transvaginal products however and is facing multiple lawsuits.

Ethicon, a division of the medical giant Johnson & Johnson, recalled and withdrew transvaginal mesh products in the GyneCare line. The GyneCare line was renamed and re-marketed them to be used in abdominal surgeries only but the company still manufactures other transvaginal products and faces thousands of lawsuits for transvaginal mesh and other surgical mesh devices.

The FDA blocked future sales of transvaginal mesh products in April of 2019 unless manufacturers can adequately demonstrate clinical safety and efficacy as an improvement over mesh-free surgical repair of SUI and POP.

Transvaginal Mesh Side Effects and Complications

Though transvaginal mesh and bladder slings were intended to improve the safety and efficacy of SUI and POP surgical repair, many patients have experienced serious complications which result in difficulties in the bladder or urinary system, reproductive tract including vagina and uterus, and general abdominal area.

Symptoms of transvaginal mesh side effects may include:

  • Bladder symptoms – difficulty urinating, urinary frequency or urgency, blood in urine, recurrent urinary tract infections
  • Vaginal symptoms – vaginal pain, vaginal bleeding, abnormal discharge, painful intercourse
  • Abdominal symptoms – abdominal pain, painful movement, swelling, inflammation

Symptoms of side effects may be due to serious complications which have developed including:

  • Mesh erosion of vaginal wall or soft tissues
  • Organ perforation due to severe tissue erosion
  • Urinary tract infections  
  • Infection of area of mesh implantation
  • Scar tissue development in vagina or other organs due to tissue damage
  • Vaginal shrinkage due to mesh contraction
  • Nerve damage in vaginal or urinary system
  • chronic pain in pelvic or abdominal organs
  • Emotional distress due to chronic health conditions, reproductive issues and need for additional treatments

Signs or symptoms of transvaginal mesh complications should be reported to a healthcare professional immediately. Many patients who experience complications related to transvaginal mesh will require additional revision or repair surgeries. In some cases, complications or side effects may be severe, may result in permanent disability or may be life-threatening.