Pelvic mesh is a tool used to help treat ailments such as Pelvic Organ Prolapse and Stress Urinary Incontinence. Pelvic Organ Prolapse involves one or more pelvic organs dropping out of their normal position. Stress Urinary Incontinence is an involuntary leaking of urine when there’s pressure on the bladder. The material used to make pelvic mesh is a plastic cut into different shapes and sizes based on its being used. There have been recent discoveries that strongly suggest that mesh may be more harmful than helpful for women.
Here’s what you need to know about the dangers of pelvic mesh.
Adverse symptoms after pelvic mesh surgery
A common symptom that women report having experienced after pelvic mesh surgery is chronic pain. The Independent Medicines and Medical Devices Safety Review notes that individuals have had to take opioid painkillers to tolerate it. Additionally, the level of pain causes difficulty for women to stand or sit comfortably. The difficulty standing has led some individuals to rely on crutches or wheelchairs to move around. Women also described experiencing pain during sexual intercourse, which has led to losing sex life.
Other symptoms reported include urinary frequency, hemorrhage, and bowel issues. In severe cases, autoimmune problems such as fatigue, brain fog, hair loss, and swelling are experienced. The psychological impacts reported to have been experienced include anxiety, depression, social withdrawal, suicidal feelings, and attempted suicide. Individuals had suffered a loss of employment, financial hardship, and deterioration of relationships.
The review noted at least one death being due to complications from a pelvic mesh procedure.
Number of women affected
The number of women affected by pelvic mesh procedures isn’t fully known yet. One of the reasons the data isn’t fully known is the challenges of identifying women who’ve had mesh complications. Complications from a pelvic mesh can take years to occur after the initial surgery. The long time it takes for complications to occur makes it more difficult to attribute them to pelvic mesh surgery. There have also been a few long-term studies or comprehensive registries tracking the complication rate after a pelvic mesh procedure. Most safety data related to the products were based on short-term studies with little or no long-term follow-up. The safety review concluded that current data didn’t reflect the range or rate of mesh complications.
Risks that women were informed of
Patients are supposed to sufficiently understand the potential risks a surgical treatment may present. They also need to be aware of alternative options to decide if they’re willing to pursue the treatment. Some women reported in the safety review that they weren’t adequately informed of the risks of mesh surgery or were even undergoing a mesh surgery. Surgeons were noted to have used terminology that didn’t fully convey the exact operation being done. Sometimes, women were only told their operation involved a repair, but not informed that mesh would be a part of the repair.
The operation was described in other ways, such as using tape, ribbon, or sling. The women were unclear that the term was an alternative to describing the pelvic mesh. In addition to doctors being responsible for informing their patients of the risks of mesh products, manufacturers are also responsible. They must provide information to clinicians and patients that’s clear and accurate in what’s known. For TVT, a mesh product used for stress urinary incontinence, the manufacturer, Ethicon, didn’t include a warning about potential pain with intercourse until 2015. The safety review notes they knew of the risk when the product was first marketed.
Lack of objectivity in research
There are concerns that developing pelvic mesh for SUI wasn’t carried out objectively. Initial investigations into the mesh product TVT were conducted in Sweden by Professor Ulmsten and funded by the Swedish Medical Research Council. The investigation concluded that the cure rate was high, and there were low levels of complications. The rights to the product were then sold to Ethicon, which is a subsidiary of Johnson and Johnson.
Ethicon agreed to pay Ulmsten $400,000 if the results achieved could be replicated by other surgeons. Professor Ulmsten teamed with five other hospitals and was the lead author on the resulting paper. The safety review concluded, because of the evidence released by Ethicon, that the professor stood to gain financially by showing that TVT was as effective in other surgeons’ hands. The results in the paper showed the same high cure rate and low complication rate in the trial conducted at the hospitals.
The paper closed by cautioning that long-term results were necessary and that the surgical method should only be viewed as a promising new technique that needs further evaluation. Despite this caution, using mesh as a treatment to SUI increased. The increase was caused by the actions of a group called SERNIP. The Department of Health was advised to set up a safety and efficacy committee to review novel surgical procedures and have similar statutory powers as the Committee on Safety of Medicines. Despite the recommendation, the Department of Health instead created a voluntary organization called SERNIP, which only made recommendations, but didn’t have any enforcement powers, and was regarded as underfunded and lacking independence.
The Independent Medicines and Medical Devices Safety Review notes that initially, SERNIP classified TVT as a Category C product. A Category C product means that it’s a product that should only be used in research. Three months later, after Ethicon challenged the C rating of the drug, SERNIP reclassified TVT as a Category A product. That means it was deemed safe to use. There were no recommendations made for any further data collection of the mesh product. Reclassification of TVT was determined by observation data from conference abstracts, and not based on peer-reviewed published papers. The safety review concludes that had SERNIP been established as an independent entity that was properly funded, there might not have been a reclassification. SERNIP was eventually replaced by NICE, which chose not to conduct any further assessments of the reclassification of TVT.
Problems with mesh removals
It’s difficult for patients dealing with pelvic mesh complications to have them removed because they are designed to be permanent. The surgery to remove a mesh such as trans obturator tape is technical and complex. The safety review points out that very few surgeons in the UK can perform this surgery. UK women have traveled overseas to have their mesh removed because of the lack of confidence in UK surgeons’ expertise performing this procedure. One of the more pressing issues the safety review reported was the lack of expert consensus on the appropriate type of removal that’s. NICE, the group that replaced SERNIP, recommended partial and full removal. Surgeons are divided on the issue. Some believe that full removal should be the preferable option, while others believe that partial or two-stage removal is more appropriate.
Pelvic mesh restrictions
The concerns related to pelvic mesh have led to an increase in restrictions on the use of the treatment. The Medicines and Healthcare Products Regulatory Agency put together a summary report in 2014. While the report concluded that mesh could be used safely for SUI, it was advised that caution must be taken when using transvaginal POP mesh. The EU group SCENIHR concluded that mesh should be used only when non-mesh repair options had failed. Additionally, the Scottish Transvaginal Mesh Implants Independent Review recommended that transvaginal POP mesh surgery should be stopped. In 2017, Australia banned all transvaginal mesh products, concluding the risks outweighed their benefits.
NICE has since restricted transvaginal POP mesh surgery to research trials only. The safety review notes that the Food and Drug Administration concluded that after pelvic mesh surgery, serious adverse effects weren’t rare. As of 2019, the FDA has halted all sales of vaginal mesh. The safety review itself also recommended pausing mesh procedures for SUI. They made this recommendation because they felt women were being exposed to the risk of life-changing injuries, and more measures were needed to mitigate those risks.
NHS England and the Department of Health and Social chose to implement the pause, only allowing mesh to be used to treat SUI under high vigilance and in exceptional circumstances. Furthermore, conditions were set that have to be met until there can be any consideration of lifting the pause on mesh surgeries. Among those conditions included all operations being reported to a national database, and surgeons having appropriate training and experience in performing the procedure.
Mesh product litigation
Medical device lawsuits are typically filed if a company is accused of selling a product that contains a manufacturing, design, or marketing defect. An example of a marketing defect would be inadequate warnings about the risks associated with a product. Lawsuits that are being filed in relation to transvaginal mesh products allege that manufacturers failed to advise doctors of the risks associated with mesh implants appropriately. There are also lawsuits alleging that polypropylene mesh implaned transabdominally for pelvic organ prolapse repair are unreasonably dangerous. Plaintiffs also claim that materials used to construct the mesh products cause adverse immune or inflammatory reactions in patients. They argue that the implantation of a defective vaginal mesh or bladder sling can result in serious harm due to retraction, contraction, or shrinkage of the mesh. As a result, it may require surgical intervention. Additionally, the plaintiffs are arguing mesh implants have caused severe and irreversible damage, including chronic pelvic pain, organic perforation, and nerve damage.
Who can file a claim?
While all patients who have had mesh surgery may be able to make a legal claim, it’s ideal only to pursue a case if you believe you’ve suffered harm due to the surgery. Some examples of harm that might be worth considering legal services include diagnosed organic damage or other ongoing severe symptoms, such as recurring infections, urinary problems, or vaginal scarring. If you’re experiencing these or other symptoms after having mesh surgery, it’s important to seek medical advice from a urogynecologist and ask if it could cause the symptoms. They will be able to offer treatment options from surgical removal or physical therapy.
With any issue involving your health, it’s important to be informed as much as you can to avoid any health issues. If you may not have been informed about the potential dangers of mesh products and have suffered from severe symptoms, it can potentially be helpful to consider legal representation. You can learn more about the litigation process from a transvaginal or transabdominal plastic mesh product surrounding the vagina from by contacting Chicago attorney Tom Plouff.