What is Transvaginal Mesh?
Transvaginal mesh is a fibrous, net-like material which is used to stabilize weak pelvic and/or bladder tissues. It is a medical device that implanted as part of a surgical procedure to repair conditions such as pelvic organ prolapse (POP) and stress urinary incontinence (SUI). Transvaginal mesh is similar to other surgical mesh implants like those used for procedures such as hernia repair. However, it is implanted through the vagina or “transvaginally” rather than through an open, 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 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.
About Transvaginal Mesh
Transvaginal mesh was first introduced in the mid-1990s for the treatment of stress urinary incontinence (SUI) and pelvic organ prolapse (POP). It is used for pelvic organ or bladder suspension surgery and is implanted transvaginally or through the vagina.
Transvaginal mesh was first approved based on a similarity to other mesh products already in use through a shortcut, known as the FDA 201(k) process which allows manufacturers to “skip” costly clinical trials. Many transvaginal mesh products were never used in humans until after their approval.
The FDA’s 501(k) process may be partly to blame and a statement was issued in 2008, indicating that transvaginal mesh products did not appear to be safer or more effective than other surgical treatments for POP or SUI and that the devices may increase the chance of serious adverse events. In 2019, the FDA further concluded that transvaginal mesh should be removed from the market and no longer available for new surgical placement. Though products were not ordered to be recalled, all manufacturers were instructed to discontinue manufacturing them and transvaginal mesh was reclassified into a higher danger category for medical devices.
Since the statement, surgeries are no longer performed with transvaginal mesh however many women continue to have complications due to existing mesh. Injuries have resulted in more than 100 thousand lawsuits being filed against transvaginal mesh manufacturers.
Serious Side Effects of Transvaginal Mesh
Transvaginal mesh has caused injury to thousands of women, including several deaths and some evidence shows that up to 10% of women who received transvaginal mesh may experience serious complications.
Vaginal mesh may erode and eventually perforate the vaginal wall. This may cause scarring, tissue shrinkage, and pain in the vaginal tissue. In some cases, the mesh may enter the abdominal area and perforate other organs.
Serious adverse events caused by vaginal mesh often require revision surgery. In some cases, multiple surgeries may be required and some of the physical damage may not be repairable. Each surgery increases the risk of infection and bleeding and injuries may be permanent. In addition, vaginal mesh implants are linked to the deaths of several victims.
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.
Complications 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.
Transvaginal Mesh FDA Warnings
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)
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 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
Transvaginal Mesh Lawsuit Information
More than 100,000 lawsuits were filed for injuries caused by transvaginal mesh. Many of these lawsuits have already been settled, but some may remain in federal, state and local courts.
Companies involved in transvaginal mesh lawsuits include:
- American Medical Systems / Endo
- Ethicon / Johnson & Johnson
- Boston Scientific
- Cook Medical Inc.
- Coloplast Corp
- Cook Medical Inc.
- C.R. Bard
Most transvaginal mesh lawsuits have been settled after several bellwether lawsuits returned $millions in awards granted to injured plaintiffs.
Transvaginal mesh settlements have included:
- A verdict of $5.5 million against C.R. Bard in 2012 to a Bakersfield couple
- A verdict of $11 million against Ethicon / Johnson & Johnson in 2013 to an Atlantic City woman
- A verdict of $2 million against C.R. Bard to a Charleston, WV woman in 2013
- A verdict of $3.3 million against Johnson & Johnson by West Virginia Woman in 2014
- A $12.5 million verdict against Johnson & Johnson by a Pennsylvania woman in 2015
- A $20 million verdict against Ethicon for a New Jersey woman in 2017
- A $41 million verdict against Ethicon for a Pennsylvania woman in 2019
- A $120 million verdict against Ethicon for a Philadelphia woman in 2019
- An undisclosed number of private settlements by AMS/Endo who agreed to pay $54 million to litigants in 2013
- After initial round of 3,000 mesh lawsuits settled in 2015 for $119 million, Boston Scientific agrees to settle remaining claims for about $800 million after losing several jury verdicts in 2018
- 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
- Endo International agrees to pay additional $775 million for an estimated 22,000 claims in 2017
Notwithstanding claims relating to this product, the drug/medical device remains approved by the U.S. FDA.