Transvaginal Mesh Side Effects

Transvaginal Mesh has caused complications and serious side effects in thousands of women. Some of these side effects may cause suffering, loss of function and interfere with a patient’s quality of life, while others are much more serious and may be life-threatening.

Transvaginal mesh is implanted to treat pelvic organ prolapse and stress urinary incontinence in women.  It has been used in millions of women to act as a “hammock” to support organs such as the bladder or uterus that have begun to “fall” due to childbirth and aging.  Transvaginal mesh is implanted through the vagina or “transvaginally” rather than through an incision made in the abdomen.

Unfortunately, severe side effects and complications may occur in up to 10% of the women who have undergone a transvaginal mesh procedure.

What are the side effects of transvaginal mesh?

Transvaginal Mesh has caused complications and serious side effects in thousands of women.  Some of these side effects may cause suffering, loss of function and interfere with a patient’s quality of life, while others are much more serious and may be life-threatening.

Side effects of transvaginal mesh may include:

  • Pain or discomfort of the vagina or in the surrounding pelvic region
  • Nerve damage including pain or loss of sensation in the vagina or surrounding pelvic region
  • Vaginal scarring
  • Vaginal shrinkage
  • Pain during intercourse
  • Recurrence of POP or SUI
  • New occurrence of SUI
  • Chronic urinary tract infection
  • Increased risk of infection
  • Excessive vaginal bleeding
  • Vaginal wall erosion
  • Vaginal or other organ perforation
  • Need for revision surgery
  • Emotional trauma

Side effects may evolve into serious adverse events (SAEs) which require extensive medical treatment and may be permanent or life-threatening.

What are complications of transvaginal mesh?

Transvaginal mesh implantation has resulted in serious adverse events for thousands of women who received the medical device to treat pelvic organ prolapse (POP) or stress urinary incontinence (SUI).

Serious adverse events (SAEs) are defined as side effects or complications which are severe and result in the need for in-patient hospitalization, cause permanent injury or death,  or require surgical intervention.

SAEs caused by transvaginal mesh have included:

Transvaginal Mesh Erosion

Transvaginal mesh implanted through the vagina can erode a portion of the vaginal wall.  Vaginal erosion caused by mesh can also result in scar tissue formation and shrinkage of vaginal tissues. Vaginal mesh erosion may require corrective or revision surgery but may be permanently disabling.  Women who develop this complication may also experience excessive bleeding, severe pain, loss of sensation, and may be unable to have sexual intercourse. In some cases, the original medical condition (SUI or POP) may also return.

Transvaginal Mesh Organ Perforation

If vaginal mesh erosion is allowed to progress, it may result in vaginal perforation.  It may also cause erosion or perforation of other pelvic or abdominal organs. Women who develop transvaginal mesh organ perforation may also experience severe pain, increased infection risk and severe bleeding.  Perforation of pelvic or abdominal organs such as the kidneys, colon or liver may increase the risk of life-threatening complications.

Transvaginal Mesh Revision Surgery

Severe side effects or complications of transvaginal mesh failure may result in a need for one or more additional surgeries.  Revision surgery may be required to remove and repair damage caused by the mesh to one or more organs. It may also be required to address the original medical problem that has not been adequately treated or to correct a new occurrence of POP or SUI.  Each surgery exposes the patient to additional risks of infection, bleeding and pain which may last a long period of time. In some cases, even with revision surgery, permanent damage may have occurred and is not reversible.

What is pelvic organ prolapse?

Pelvic organ prolapse (POP) occurs when the muscles that normally hold pelvic organs in place become weakened.  Stretching of these muscles can allow pelvic organs such as the bladder or uterus to fall or “prolapse” from their normal place and push against the vaginal walls or rectum.  POP is most common after childbirth or surgery.

What is stress urinary incontinence?

Stress urinary incontinence (SUI) occurs when physical movement causes inadvertent release of urine (incontinence).  SUI may occur after movement such as laughing, sneezing or reaching puts pressure on the bladder. It is most common in women who have weakened pelvic muscles or weakened sphincter muscles in the neck of the bladder.

What is transvaginal mesh?

Transvaginal mesh is a fibrous, net-like material which is used to stabilize weakened pelvic and bladder tissues.  It is a medical device that implanted as part of a surgical repair to correct conditions such as pelvic organ prolapse (POP) and stress urinary incontinence (SUI).

Transvaginal mesh is similar to other surgical mesh implants used for procedures such as hernia repair.  However, it is implanted through the vaginal opening rather than as part of an abdominal surgery.

Because it is similar to other types of surgical mesh, transvaginal mesh was approved under the FDA 510(k) pathway which does not require clinical testing.  Many women who have undergone transvaginal mesh implantation have developed complications or experienced serious side effects due to the implant.

What are the symptoms of transvaginal mesh complications?

Transvaginal mesh is used in thousands of gynecologic and urologic repair procedures every year.  In 2011, based on high numbers of adverse event reports, an FDA review concluded that transvaginal mesh procedures caused a greater risk of complications than non-mesh repairs.

Vaginal mesh complications may include:

  • Erosion through vaginal wall or soft tissues
  • Organ perforation may occur if mesh erosion is severe
  • Urinary tract infections or other problems
  • Infection of area of mesh implantation
  • Scar tissue development in vagina or other areas
  • Vaginal shrinkage due to mesh contraction
  • Nerve damage or chronic pain in pelvic or abdominal organs
  • Emotional distress due to chronic health conditions and need for additional treatments

Symptoms of transvaginal mesh complications 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

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

Has transvaginal mesh been recalled by the FDA?

Despite thousands of reports of serious harm caused by transvaginal mesh, including multiple deaths, it has not been recalled by the Food and Drug Administration.  The FDA has strengthened warnings multiple times and required that additional safety studies be performed but several companies continue to manufacture and market the devices.

Have transvaginal lawsuits been settled?

Tens of thousands of lawsuits have already been filed for injuries caused by transvaginal mesh.  Many of these lawsuits have already been settled, but thousands more remain in federal, state and local courts.

Notwithstanding claims relating to this product, the drug/medical device remains approved by the U.S. FDA. 

Discontinued Transvaginal Mesh

Transvaginal mesh products have been used in over a million female patients, many of whom have experienced severe complications.  More than 100,000 lawsuits have been filed against manufacturers, causing companies to discontinue some transvaginal mesh brands.

Discontinued transvaginal mesh products include:

  • ProteGen, made by Boston Scientific Corporation
  • ObTape, made by Mentor Corporation
  • Avaulta Plus, made by C. R. Bard Incorporated
  • Gynecare Prolift, made by Ethicon, a Johnson & Johnson company
  • Gynecare Prolift + M, made by Ethicon, a Johnson & Johnson company
  • Gynecare TVT Secure System, made by Ethicon, a Johnson & Johnson company
  • Gynecare Prosima Pelvic Floor Repair System, made by Ethicon, a Johnson & Johnson company
  • Apogee Vault Suspension System, made by American Medical Systems (AMS)/Endo Pharmaceuticals
  • Apogee Pelvic Floor System, made by American Medical Systems (AMS)/Endo Pharmaceuticals
  • BioArc Sling System, made by American Medical Systems (AMS)/Endo Pharmaceuticals
  • In-Fast Ultra Transvaginal Sling, made by American Medical Systems (AMS)/Endo Pharmaceuticals
  • Perigee System, made by American Medical Systems (AMS), acquired by Endo Pharmaceuticals

Transvaginal Mesh FDA Warning

In response to the growing number of reported complications from transvaginal mesh implants, the FDA issued its first public health notification on October 20, 2008. This notification stated that there were over one thousand cases of adverse effects occurring as a result of transvaginal mesh procedures.

Reported complications include:

  • Bowel  or bladder perforation
  • Vaginal scarring
  • Mesh erosion inside the body
  • Dyspareunia (pain during sex)
  • Infections
  • Pain

Updated Transvaginal Mesh FDA Warning

In January of 2011, the FDA updated this warning to inform the public that these issues are not rare. Almost three thousand more cases were reported between 2008 and 2011. These also included many cases of recurrence of pelvic organ prolapse (POP) and stress urinary incontinence (SUI), even some cases in which the patient was treated for POP and developed SUI as a result of the surgery.

The FDA launched a systematic review of all of the published scientific literature from 1996 through 2011 to determine the safety and effectiveness of transvaginal mesh.  This review revealed that neither quality of life nor effectiveness of treating symptoms is improved by using transvaginal mesh over traditional non-mesh repairs.

The FDA findings also stated:

  • Using mesh introduces problems not present in traditional non-mesh surgeries
  • Mesh inserted through the abdomen for POP repairs did not pose the same risks as mesh implanted transvaginally
  • There is no evidence that using mesh to reinforce the top of the vagina or the back wall of the vagina increases the effectiveness over traditional surgeries without mesh
  • A previously unidentified risk called mesh contraction, resulting in vaginal shortening, vaginal tightening, and vaginal pain
  • Mesh erosion is the most common complication arising from transvaginal mesh surgery to treat POP

Transvaginal Mesh Revision Surgery

In the case of mesh erosion, the only way to remove the transvaginal mesh is through revision surgery.  This can be painful, difficult, and in some cases impossible. The mesh begins to fuse with the patient’s tissues and organs and must be removed piece by piece as it is visible to the surgeons. It is often required to undergo numerous surgeries to remove all of the pieces when the mesh had begun to erode.

In some cases, the surgeons are not able to successfully find and remove all pieces of mesh.  The surgery also carries its own risks, such as pain during intercourse, excessive bleeding, urinary incontinence, and damage to the bladder, bowel, and other organs.

FDA Recommendations for Health Care Providers

In concurrence with the original FDA warning set forth in 2008, the FDA continues to recommend that health care providers form the first line of defense against complications arising from transvaginal mesh surgery by being aware of risks and benefits.

Health care providers should:

  • Complete specialized training for mesh placement
  • Be watchful for adverse effects from the mesh, especially erosion and infection
  • Inform patients that mesh is permanent, once implanted it may not be possible to remove
  • Inform patients about the possibility of adverse effects on quality of life, including pain during sexual intercourse
  • Be aware that in most cases, mesh is not required and all complications can be avoided by not using it
  • Be aware that placing mesh abdominally may lower the risk of complications when compared to transvaginally
  • Notify the patient if mesh will be used and provide information on the specific product to be used

Transvaginal Mesh Organ Perforation

Transvaginal mesh can erode or embed itself into the vaginal wall.  Eventually over time, the mesh may perforate the vagina.  This may cause significant pain, thickening of the vaginal wall, vaginal shrinkage, painful or impossible intercourse, vaginal bleeding, and increase the risk of severe infection.  It will usually require surgery to remove the vaginal mesh and correct the damage done to the vagina.  In many cases, multiple surgeries will be required and damage may be permanent.  If the condition is not treated immediately, the patient may be at risk of death.

Transvaginal mesh may also perforate other organs in the abdominal cavity such as the bladder, colon, or kidneys.  Perforation of essential organs may cause emergent or life-threatening medical conditions including sepsis or kidney failure.  Perforation of essential organs will certainly require immediate surgical correction and damage may be permanent or result in death.

Transvaginal organ perforation is cited as the most frequently reported serious adverse event caused by the device.  Between 2008 and 2010, the FDA received nearly 3,000 serious adverse event reports regarding transvaginal mesh, most of which were organ perforation events.  During that period, at least 7 deaths are attributed to the device.

Based on those reports, the FDA strengthened warnings about the device stating that the mesh did not appear to be more effective than other SUI or POP methods and put the patient at a greater risk than other procedures.  The FDA required that 44 manufacturers of transvaginal mesh products conduct over 100 clinical studies to evaluate the safety and risks of their products.  Despite this warning and the results of clinical studies, neither the FDA, nor the manufacturers have withdrawn the devices from the market.

Transvaginal Mesh Lawsuits

Many of the problems that have occurred from transvaginal mesh implants may be attributable to the lack of clinical studies performed before the devices were put into use.  None of the transvaginal mesh products had been used in women before they were introduced to the public.  The first transvaginal “bladder sling” was a mesh product that was recalled just three years after its approval.  Despite the clear risks, companies continued to create and manufacture additional products to eventually be used in over 75 thousand procedures each year.

To date nearly 100 thousand lawsuits have been filed against manufacturers of the devices particularly against notable companies including:

  • American Medical Systems / Endo
  • Ethicon / Johnson & Johnson
  • Boston Scientific
  • Cook Medical Inc.
  • Coloplast Corp
  • Cook Medical Inc.
  • C.R. Bard

Lawsuits have claimed that the companies failed to conduct appropriate testing of the devices to be used for female pelvic disorders, concealed information about and misled the FDA and medical community as well as the public at large regarding the efficacy and safety of the devices, and failed to establish appropriate safe and effective methods for removal of implants.

Of the near 100 thousand lawsuits currently filed against manufacturers of the transvaginal mesh products, some have been settled including:

  • A jury verdict of $5.5 million against C.R. Bard in 2012 to a Bakersfield CA couple
  • A jury verdict of $3.35 million against Ethicon / Johnson & Johnson in 2013 to an Atlantic City, NJ woman
  • A jury verdict of $2 million against C.R. Bard to a Charleston, WV woman in 2013
  • An undisclosed number of private settlements by AMS/Endo who agreed to pay $54 million to litigants in 2013
  • A Bloomberg News indicating that certain manufacturers were considering out of court settlement of up to $30 thousand per claim but an agreement has not been announced
  • Settlement of 20 thousand cases for $830 million by AMS/Endo
  • Settlements of 400 lawsuits for up to $16 million by Coloplast

Many lawsuits have been consolidated into multidistrict litigation (MDL) in the U.S. District Court for the District of West Virgina and include over 40 transvaginal mesh products.  The cases will be supervised by Chief Judge Joseph R. Goodwin and include at least six different MDL consolidations.

Plaintiffs can be awarded for both actual damages (medical costs, disability) and punitive damages (to punish the company).  Thousands of transvaginal mesh lawsuits have not been settled and many more are expected.

Transvaginal Mesh FDA Ban and Voluntary 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 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 Revision Surgery

Transvaginal mesh is used in surgical procedures performed to treat stress urinary incontinence (SUI) and pelvic organ prolapse (POP) in women.  It is a fibrous material which is intended to give support to weakened bladder or vaginal tissue and is implanted through the vagina (transvaginally) rather than through an abdominal incision.

SUI and POP develops in some women after child-bearing or hysterectomy or may develop in older women due to aging tissues which allow pelvic organs to “fall” or prolapse.  Transvaginal mesh was introduced to be safer and more effective than other procedures requiring abdominal surgery. Unfortunately, it has been shown to cause severe side effects in up to 10% of the women who receive it.  Many of these women develop serious complications and may be required to undergo a transvaginal mesh revision surgery.

What is transvaginal mesh revision surgery?

Transvaginal mesh revision surgery is performed to correct damage caused by the failure of a transvaginal mesh implantation procedure.  It may be required for a number of reasons including:

  • Transvaginal mesh erosion – implanted mesh may begin to erode the vaginal wall or other organs in the pelvic and abdominal region
  • Transvaginal mesh organ perforation – vaginal mesh erosion may become severe and result in complete perforation of the vagina or abdominal organs such as the colon or kidneys
  • Recurrence of POP or SUI – failure of the implantation procedure may cause the original medical problem of pelvic organ prolapse or stress urinary incontinence to reoccur
  • New occurrence of organ prolapse or incontinence – erosion or damage to tissues caused by transvaginal mesh may result in a new occurrence of POP or SUI

In some cases, patients may require multiple surgeries to complete a transvaginal mesh revision repair.  One or more surgeries may be required to remove the mesh, repair damage to tissues or organs, and/or to treat the SUI or POP condition.

Revision surgery is often more painful and complex than the original transvaginal procedure.  Each additional surgery exposes the patient to additional infection and anesthesia risks, along with an increased chance of complication associated with any type of surgery.  Revision surgery may also require longer recovery times and in some cases, damage to the pelvic organs may be permanent.

Patients who have developed complications related to transvaginal mesh failure may experience nerve damage with loss of sensation, vaginal shrinkage, chronic pain, and may be unable to have sexual intercourse.  Severe or chronic problems associated with transvaginal mesh failure and revision surgery may also contribute to long-lasting emotional trauma.