Why Is Vaginal Mesh Surgery Controversial?

Types of Vaginal Mesh Procedures

There are three main surgical treatments performed with surgical mesh to treat pelvic floor disorders:

1. Transvaginal mesh procedures;
2. Transabdominal mesh procedures; and
3. Mini-sling procedures.

Transvaginal mesh procedures involve placing mesh through vaginal incisions to treat anterior or posterior wall prolapse.

Transabdominal procedures access the pelvic area through abdominal incisions for apical prolapse repair.

Mini-sling procedures specifically address stress urinary incontinence using smaller mesh strips placed beneath the urethra.

Most surgical mesh made of synthetic materials can be found in knitted mesh or non-knitted sheet forms.

Each procedure type targets different pelvic floor conditions.

Transvaginal approaches primarily treat cystocele (bladder prolapse) and rectocele (rectal prolapse), while transabdominal methods address uterine or vaginal vault prolapse.

Most patients with pelvic organ prolapse are asymptomatic.

Prolapse symptoms become more bothersome as the bulge protrudes past the vaginal opening.

Materials Used in Vaginal Mesh Implants

The synthetic materials used can be either absorbable, non-absorbable, or a combination of absorbable and non-absorbable materials.

Most vaginal mesh products use polypropylene, a permanent synthetic plastic material that remains in the body indefinitely.

Some manufacturers also produce mesh from biological materials derived from animal tissues.

Surgeons have used surgical mesh since the 1950s to repair abdominal hernias; in the 1970s, gynecologists specializing in female pelvic medicine began implanting surgical mesh for the abdominal repair of POP and, in the 1990s, for the transvaginal repair of POP.

Major manufacturers historically included Boston Scientific, Coloplast, and Ethicon, producing products like Uphold Lite, Xenform, and ProteGen.

On April 16, 2019, after reviewing their premarket approval (PMA) applications, the FDA ordered all manufacturers of surgical mesh intended for transvaginal repair of pelvic organ prolapse (Boston Scientific Uphold Lite, Boston Scientific Xenform, and Coloplast Direct Fix Anterior) to stop selling and distributing their products immediately.

Major Complications and Side Effects of Vaginal Mesh

The FDA has received thousands of reports of complications involving the use of mesh for transvaginal POP repair.

These complications have profoundly impacted women’s lives, with the FDA reporting that it had received 2,874 reports of injury, death, malfunctions, and other transvaginal mesh-related complications from Jan.1, 2008, to Dec. 31, 2010.

Common Physical Complications

The most common problems reported include severe pelvic pain, pain during intercourse, infection, bleeding, organ perforation, and urinary problems from mesh eroding into surrounding tissues.

Research shows 9.8% of patients undergoing surgical mesh insertion for SUI experienced a complication peri-procedurally, within 30 days or within 5 years of the initial mesh insertion procedure.

Mesh exposure represents the most frequent complication.

This occurs when the mesh moves or erodes through the vaginal wall, sometimes extending into nearby organs like the bladder or rectum.

Women experiencing erosion report pain, bleeding, infections, painful intercourse, or the exposed mesh becoming visible or felt inside the vagina.

One study reported a 32% corrective rate for SUI surgery involving a midurethral sling procedure, while others found the rate of mesh-related complications to be approximately 15% to 25%.

Bacterial colonization may contribute to additional complications, as 44 samples (90%) were culture positive, with a higher diversity of species and more Gram-negative bacteria and polymicrobial cultures in the MRC cohort than the reference cohort.

Impact on Daily Life and Relationships

Most participants experienced negative emotions as a result of mesh complications and subsequent continuous pain.

These ranged from feeling robbed, trapped, regretful, anxious, and suicidal.

The psychological toll extends beyond physical symptoms, with women’s lives having been irreversibly altered for the worse owing to mesh complications, causing chronic pain and impacting their quality of life.

Sexual dysfunction proves particularly distressing.

Physical pain includes pain during sexual intercourse (dyspareunia).

Physical limitations can also affect basic activities that prevent women from sitting comfortably, exercising, or performing routine tasks.

Revision Surgery Challenges

Complete transvaginal mesh removal is possible for some women, while only part of the mesh can be removed in other women due to issues from the type of mesh that was originally used.

The difficulty increases over time as tissue grows around and embeds the mesh.

Revision surgery removes or repairs transvaginal mesh implants, but it’s a difficult procedure and may cause pain compared to the initial mesh procedure.

Studies indicate 1 in every 30 women may need a repeat surgery to remove or revise the mesh, up to 10 years after the initial operation.

Patients were also excluded if they were unable to provide informed consent, were undergoing chronic immunosuppressive therapy, or had an autoimmune disorder.

Multiple revision surgeries often become necessary, with over 50% of women who experienced erosion with non-absorbable synthetic mesh needing to have the mesh surgically removed.

Some patients required two or more operations after the mesh was removed.

Why Did the FDA Issue Warnings About Vaginal Mesh?

The FDA’s escalating safety actions regarding vaginal mesh stemmed from an alarming pattern of adverse events.

Issued safety communications in 2008 and 2011 that warned doctors and consumers about an increase in adverse event reports related to mesh used for urogynecological procedures.

Timeline of FDA Safety Communications

The regulatory journey began with growing concerns about complications associated with mesh.

In 2008, the FDA issued its first public health notification regarding transvaginal mesh, following receipt of over 1,000 adverse event reports from nine surgical manufacturers since 2005.

Initially, the safety communication described complications from transvaginal mesh as rare.

The situation escalated dramatically when, from January 2008 to December 2010, the FDA received 2,874 additional reports of complications associated with surgical mesh devices used to repair pelvic organ prolapse (POP) and stress urinary incontinence (SUI), with 1,503 reports related to POP repairs and 1,371 associated with SUI repairs.

This prompted stronger action.

The FDA issued an update on July 13, 2011, noting complications associated with surgical mesh for transvaginal repair of POP are not rare and that it is not clear that transvaginal POP repair with mesh is more effective than traditional non-mesh repair, and it may expose patients to greater risk.

In 2016, the FDA issued one order to reclassify these medical devices from class II, which generally includes moderate-risk devices, to class III, which generally includes high-risk devices.

Finally, July 2018 was the deadline for applications to be filed for premarket approval for any surgical mesh marketed for transvaginal pelvic organ prolapse (POP) repair.

Manufacturers that did not file PMAs by this deadline were required to withdraw their products from the market.

April 16, 2019: The FDA ruling ordered all manufacturers of surgical mesh intended for transvaginal repair of pelvic organ prolapse to stop selling and distributing their products immediately.

Clinical Evidence That Led to FDA Action

We analyzed 1,103 MDRs submitted to the MAUDE database from 2005 to 2007 for pelvic mesh adverse events.

The FDA’s analysis revealed concerning patterns.

The most frequent complications reported to the FDA include mesh erosion through the vagina, pain, infection, bleeding, dyspareunia, organ perforation, urinary problems, and voiding dysfunction.

Scientific scrutiny intensified when the panel recommended that to support a favorable benefit-risk profile, the effectiveness of surgical mesh for transvaginal repair of POP should be superior to native tissue repair at 36 months and the safety outcomes for surgical mesh for transvaginal repair of POP should be comparable to native tissue repair.

In reviewing the PMAs submitted by the two manufacturers, the agency determined they failed to provide an adequate assessment of the long-term safety of these devices and failed to demonstrate an acceptable long-term benefit of these devices compared to transvaginal surgical tissue repair without the use of mesh.

The evidence showed transvaginal mesh products for treating POP have been approved on the basis of weak evidence over the last 20 years.

The MAUDE database was limited in its ability to collect, quantify, and standardize real-life adverse events related to transvaginal mesh.

Despite these limitations, the accumulated evidence proved sufficient for regulatory action, as the FDA had not found conclusive evidence that using transvaginally placed mesh improves clinical outcomes any more than traditional non-mesh treatments, and it may expose patients to greater risk.

Legal Rights for Women Harmed by Vaginal Mesh

Women experiencing complications from vaginal mesh implants have legal recourse through product liability claims.

The main claims are that manufacturers produced faulty products and failed to warn the public of the health risks.

Since litigation began, over 100,000 Transvaginal Mesh Lawsuits have been filed across courts in the United States on behalf of women injured by vaginal mesh and pelvic mesh products.

Grounds for Vaginal Mesh Lawsuits

Transvaginal mesh lawsuits claim that several manufacturers of transvaginal mesh knew that their products were defective and could cause complications such as erosion, organ perforation, severe pain, painful sex, mesh migration and other serious issues that require surgical management to remove the mesh.

Legal theories supporting these claims include design defects, manufacturing defects, failure to warn, and negligent marketing practices.

Following Food and Drug Administration communications about the safety of transvaginal prolapse, more than 73,000 patients with complications from the treatment of pelvic organ prolapse (POP) or stress urinary incontinence (SUI) have filed product liability claims.

Courts have recognized that a recent study conducted by researchers at the University of Sheffield in England reveals that most vaginal and pelvic mesh implants may have been fundamentally flawed in their design and manufacturing.

Successfully resolved cases demonstrate viable legal grounds.

Around 140 women in England who suffered severe side effects from vaginal mesh implants have won a settlement, expected to total “millions of pounds,” after taking legal action against manufacturers Johnson & Johnson, Bard, and Boston Scientific.

Compensation Available in Mesh Cases

The estimated payout range for vaginal mesh lawsuits is between $175,000 and over $450,000.

Compensation typically covers multiple categories of damages.

Damages that can be recovered in a vaginal mesh lawsuit include past and future medical expenses, lost wages, pain and suffering, loss of consumption, and in rare cases, punitive damages.

A Philadelphia jury issued one of the largest transvaginal mesh verdicts to Susan McFarland for $120 million in 2019.

As of May 2025, average vaginal mesh settlement amounts have ranged from $40,000 to $450,000. Plaintiffs who have taken their cases to trial have received millions in jury verdicts, but some of these verdicts have been overturned or reduced after appeal.

Settlement values depend on the severity of the injury, the ability to prove the connection between the injury and the mesh, and any statements made by manufacturers.

Statute of Limitations Considerations

Time limits for filing vary by state.

Every state has its statute of limitations ranging from 1 to 6 years, generally starting from the date the claimant either underwent mesh surgery or discovered the complications related to the mesh.

The discovery rule states that the statute of limitations begins when the plaintiff knew or should have known that the vaginal mesh caused the injury or complications.

Product liability statutes of limitations are not always as straightforward as they seem.

Many women assume they are out of time when, in reality, they may still have a valid claim.

This situation arises because in most states, the deadline doesn’t necessarily start when the mesh was implanted but rather when complications first became apparent, which could be years later.

As long as the first occurrence of your vaginal mesh complications occurred with the last one or two years, you will probably not have to worry about the statute of limitations.

Given these variations, it is important to consult with a transvaginal mesh lawyer to determine whether you meet the eligibility requirements.

Steps to Take If You've Had Vaginal Mesh Complications

Taking prompt action when experiencing mesh-related problems proves important for both medical treatment and legal remedies.

If you have concerns about complications as a result of vaginal mesh, you should inform your GP.

Early intervention often leads to better outcomes.

Medical Documentation and Treatment

A complete medical history is the first key to a comprehensive and assertive diagnosis of mesh-related complications.

Document all symptoms meticulously, including pain, bleeding, infections, painful intercourse, vaginal discharge, or the mesh becoming visible or felt inside the vagina.

Medical evaluation should include comprehensive testing.

Your doctor will use imaging tests to see where the mesh is placed and locate the area that’s causing problems.

Your doctor may use ultrasound, CT, MRI, or another test that involves a thin, flexible tube and a camera to examine the inside of your bladder (cystoscopy), rectum (proctoscopy), or colon (colonoscopy).

Treatment options vary based on severity.

Approaches to the management of mesh-related complications in pelvic floor surgery include observation, physical therapy, medications, and surgery.

For minor complications, in less severe cases, mesh complications can be treated with vaginal estrogen cream and time to allow tissues to heal.

When surgery becomes necessary, specialized expertise matters.

Complete transvaginal mesh removal is possible for some women, while only part of the mesh can be removed in other women due to issues from the type of mesh that was originally used.

Surgeons with specialized training use the least invasive approach to remove the portion of mesh that’s causing symptoms and restore pelvic health.

Evaluating Your Legal Options

Begin by securing comprehensive medical records documenting your mesh complications.

Medical expenses are calculated through bills and documentation of expenses related to the vaginal mesh complication that caused your injury.

Preserve all documentation related to your initial surgery, complications, and subsequent treatments.

Contact Jessica Paluch-Hoerman at TruLaw for a free case evaluation using the chat on this page.

Health care providers recommend consulting with an attorney to determine whether you meet the eligibility requirements.

During the consultation, you should bring your medical records, surgical reports, diagnostic imaging results, and documentation of all symptoms and treatments.

Key questions to ask during your consultation include timeline considerations for your specific case, potential compensation based on your injuries, litigation strategy options, and the expected duration of your case.

An attorney can help determine if you meet the eligibility requirements necessary to file a claim.

Remember that you will not have to pay anything to file a lawsuit through a contingency agreement.

This arrangement ensures access to legal representation regardless of financial circumstances.

Jessica Paluch-Hoerman and TruLaw work on contingency, meaning you pay legal fees only if your case achieves a favorable outcome.

Failing to file a lawsuit within the state-specific statute of limitations can result in the forfeiture of the right to compensation.

Contact TruLaw immediately using the chat feature on this page to receive an instant case evaluation and determine whether you qualify to join others in filing a vaginal mesh lawsuit today.

How Can A Transvaginal Mesh Attorney from TruLaw Help You?

Our Transvaginal Mesh attorney at TruLaw is dedicated to supporting clients through the process of filing a Transvaginal Mesh lawsuit.

With extensive experience in product liability cases, Jessica Paluch-Hoerman and our partner law firms work with litigation leaders and medical experts to prove how defective mesh implants caused you harm.

TruLaw focuses on securing compensation for medical expenses, revision surgeries, pain and suffering, lost income, and other damages resulting from your transvaginal mesh injuries.

We understand the physical and emotional toll that Transvaginal Mesh complications have on your life and provide the personalized guidance you need when seeking justice.

Meet the Lead Transvaginal Mesh Attorney at TruLaw

Meet our lead Transvaginal Mesh attorney:

• Jessica Paluch-Hoerman: As founder and managing attorney of TruLaw, Jessica brings her experience in product liability and personal injury to her client-centered approach by prioritizing open communication and personalized attention with her clients. Through TruLaw and partner law firms, Jessica has helped collect over $3 billion on behalf of injured individuals across all 50 states through verdicts and negotiated settlements.

How much does hiring a Transvaginal Mesh lawyer from TruLaw cost?

At TruLaw, we believe financial concerns should never stand in the way of justice.

That’s why we operate on a contingency fee basis—with this approach, you only pay legal fees after you’ve been awarded compensation for your injuries.

If you or a loved one experienced pain, bleeding, infection, organ perforation, mesh erosion, or other complications from transvaginal mesh implants, you may be eligible to seek compensation.

Contact TruLaw using the chat on this page to receive an instant case evaluation and determine whether you qualify to join others in filing a Transvaginal Mesh lawsuit today.

TruLaw: Accepting Clients for the Transvaginal Mesh Lawsuit

Transvaginal mesh lawsuits are being filed by women across the country who suffered serious complications from pelvic mesh implants used to treat pelvic organ prolapse and stress urinary incontinence.

TruLaw is currently accepting clients for the Transvaginal Mesh lawsuit.

A few reasons to choose TruLaw for your Transvaginal Mesh lawsuit include:

• If We Don’t Win, You Don’t Pay: The Transvaginal Mesh lawyers at TruLaw and our partner firms operate on a contingency fee basis, meaning we only get paid if you win.
• Expertise: We have decades of experience handling product liability cases similar to the Transvaginal Mesh lawsuit.
• Successful Track Record: TruLaw and our partner law firms have helped our clients recover billions of dollars in compensation through verdicts and negotiated settlements.

If you or a loved one suffered pain, infection, bleeding, organ damage, or other complications after receiving a transvaginal mesh implant, you may be eligible to seek compensation.

Contact TruLaw using the chat on this page to receive an instant case evaluation that can determine if you qualify for the Transvaginal Mesh lawsuit today.