Listed below is a collection of Frequently Asked Questions regarding vaginal mesh.
What type of medical device is vaginal mesh?
Vaginal mesh, also known as the transvaginal mesh implant, is a sling-like medical device that is used to help support the internal pelvic organs, of women who have lost the strength in the muscles of their pelvic floor.
What disease, ailment, or illness is vaginal mesh meant to treat?
Vaginal mesh is used to treat women with pelvic organ prolapse (POP) or stress urinary incontinence (SUI).
How is vaginal mesh able to treat pelvic organ prolapse (POP) or stress urinary incontinence (SUI)?
Vaginal mesh is able to treat pelvic organ prolapse (POP) or stress urinary incontinence (SUI) by lifting and supporting the weight of the bladder, uterus, and rectum.
What kinds of side effects has vaginal mesh been linked to?
According to a range of reliable and credible sources, vaginal mesh has been linked to a number of side effects including mesh erosion, vaginal scarring, uterus perforation, and revision surgeries.
Vaginal Mesh Erosion
Is there medical proof or clinical evidence connecting vaginal mesh to the increased risk of mesh erosion?
Yes. In (1)March 2003, the FDA published an article linking vaginal mesh to the increased risk of mesh erosion, a condition that occurs when the coarse edges of the synthetic material of the mesh cut through the vaginal lining and other neighboring organs. According to the article, The most common complication reported through Medical Device Reports (MDRs) for surgical mesh slings next to pain is mesh erosion through the vagina (also called exposure, extrusion or protrusion).
Is there a definitive medical definition of mesh erosion? If so, what is it?
Yes. Autologous materials such as muscle were first used to provide additional anatomic support to the periurethral and pelvic tissues. However, attempts to minimize the invasiveness of the procedures have led to the use of synthetic materials. Complications such as infection and erosion or extrusion associated with these materials may be troublesome to manage.
What is the survival rate, or quality of life, for a person that has been diagnosed with mesh erosion?
Symptoms related to transvaginal mesh erosion can appear as soon as one month after surgery, and generally occur sooner than in surgeries where the mesh was implanted through the abdomen. Infection due to mesh erosion can be serious and prompt treatment is often required.
Are their any symptoms of a transvaginal mesh induced erosion that I should watch out for?
Yes. People that suffered from a transvaginal mesh erosion have been known to experience one or more of the following symptoms prior to diagnosis:
- Difficulty urinating
- Infections near the mesh
- Severe pelvic pain
- Urinary tract problems
- Damage to nearby organs
Vaginal Mesh Vaginal Scarring
Is there medical proof or clinical evidence connecting vaginal mesh to the increased risk of vaginal scarring?
Yes. In (2)October 2008, the FDA released a Health Notification linking vaginal mesh to the increased risk of vaginal scarring, a thickening of the vaginal walls. According to the Health Notification, vaginal scarring and mesh erosion led to a significant decrease in patient quality of life due to discomfort and pain, including dyspareunia.
Is there a definitive medical definition of vaginal scarring? If so, what is it?
Yes. Vaginal scarring, also known as vaginal scar tissue shrinkage, can thicken the vaginal walls, making intercourse painful or impossible and also creating generalized vaginal discomfort or pain.
What is the survival rate, or quality of life, for a person that has been diagnosed with vaginal scarring?
Need for additional surgeries as problems caused by transvaginal mesh may require surgery to treat them and the patient may require corrective surgery to treat the original problem that has not been cured. According to urologyteam.com, emotional problems have been observed in women related to the continuous need to have additional surgeries and physical exams and possible permanent disability.
Are their any symptoms of a vaginal mesh induced vaginal scarring that I should watch out for?
Yes. People that suffered from a vaginal mesh induced vaginal scarring have been known to experience one or more of the following symptoms prior to diagnosis:
- Vaginal discharge
- Burning genital area
- Shortened vaginal canal
- Painful intercourse
- Limited penetration
Vaginal Mesh Uterus Perforation
Is there medical proof or clinical evidence connecting vaginal mesh to the increased risk of uterus perforation?
Yes. In (3)February 2009, the FDA produced an Adverse Event Report linking vaginal mesh to the increased risk of uterus perforation, the penetration of the wall of an organ or artery in the body. According to the Adverse Event Report, the mesh from the sling had eroded into the patient’s bladder. In addition, it was also found that one of the anchors that is drilled into the pubic bone was put through the patient’s bladder.
Is there controversy over vaginal mesh for POP versus TVM Mesh for SUI?
Yes. In research reviewed by the FDA ten percent of women treated with vaginal mesh to correct POP faced severe and life changing complications within one year of the surgery. A lot of women are being told all kinds of untrue myths about mesh being safe, including that it is only mesh for POP, and NOT for SUI that is the problem. This is NOT true.
What is the survival rate, or quality of life, for a person that has been diagnosed with uterus perforation?
Even the newest “slings” are causing severe complications. The FDA’s July 2011 warning specifically said that complications are “NOT rare”. This was a direct change and correction from their previous warning where they indicated the opposite (that complications were rare). Obviously, the stats were great enough for them to change that statement and put out the July 2011 warning.
Are their any symptoms of a transvaginal mesh induced uterus perforation that I should watch out for?
Yes. People that suffered from a transvaginal mesh induced uterus perforation have been known to experience one or more of the following symptoms prior to diagnosis:
- Pelvic pain
- Vaginal bleeding
- Infection around mesh
- Urinary problems
- Pain during intercourse
Vaginal Mesh Revision Surgeries
Is there medical proof or clinical evidence connecting vaginal mesh to the increased risk of revision surgeries?
Yes. In (4)December 2010, the FDA published an Adverse Event Report linking TVM Mesh to the increased risk of revision surgeries, recurring surgeries necessary to address adverse effects caused by the surgical mesh. According to the Adverse Event Report, a patient began having problems with severe pain and bleeding because of mesh erosion in her vagina. She was put back on the table for surgery to remove the mesh that was exposed. Then it happened again she had to have another surgery for more mesh erosion. She is still in constant pain, still bleeding heavily, and now has additional problems such as loss of bowel control and painful urination.
Is there a definitive medical definition of revision surgeries? If so, what is it?
Yes. The FDA issued an additional safety alert in which it cautioned that at least ten percent of women treated with the vaginal sling for POP or SUI experienced movement of the mesh sling or erosion during the first year after surgery. Half of those patients were forced to undergo corrective surgery to take out the mesh.
What is the survival rate, or quality of life, for a person that has been diagnosed with revision surgeries?
The FDA is issuing this update to inform you that serious complications associated with surgical mesh for transvaginal repair of POP are not rare. This is a change from what the FDA previously reported on Oct. 20, 2008. Furthermore, it is not clear that transvaginal POP repair with mesh is more effective than traditional non-mesh repair in all patients with POP and it may expose patients to greater risk.
Are their any symptoms of a TVM Mesh induced revision surgeries that I should watch out for?
Yes. People that suffered from a TVM Mesh induced revision surgeries have been known to experience one or more of the following symptoms prior to diagnosis:
- Recurrence of prolapse or incontinence
- Neuro-muscular problems
- Severe pelvic or groin pain
- Nerve damage
- Urinary tract infections
Other TVM Mesh Side Effects
Are there any other side effects that women taking TVM Mesh should be aware of?
Yes. In (5)October 2, 2011, the FDA released an Adverse Event Report linking TVM Mesh to a collection of other painful and uncomfortable side effects. Although not always life threatening, the more common of those include:
- Rupture to Other Organs
- Internal Bleeding
- Kidney Infections
- Urinary Tract Infections
- Blood Infections
Vaginal Mesh In The News
Has there been anything in the news relating to vaginal mesh and the side effects it has been believed to cause?
(6)January 14, 2016 – CNN Money runs a story notifying the public of the counterfeit material lawsuit being filed against Boston Scientific. According to the story, The West Virginia suit goes beyond the claims made in those cases. It says Boston Scientific — one manufacturer of mesh implants — “concocted a scheme” to defraud regulators and received counterfeit materials from China.
(7)February 17, 2016 l – Fox News Health runs a story linking synthetic vaginal mesh to an increased risk of severe side effects. According to the story, Researchers have found that up to three years after surgery, women whose prolapse was repaired with artificial mesh were also more likely to have incontinence, exposed mesh or another surgery.
(8)September 9, 2011 – ABC News publishes an article sharing the story of Linda Gross of Watertown, S.D. According to the article, that ever since her implantation in 2006, she has had urinary complications, constant pain as her body continues to reject the mesh. Twelve surgeries have failed to remove all the mesh or relieve her pain and swelling.
Sources & Additional Information
(1) FDA. “Considerations about Surgical Mesh for SUI.” U.S. Department of Health & Human Services, March 27, 2003. http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/UroGynSurgicalMesh/ucm345219.htm.
(2) FDA. “FDA Public Health Notification: Serious Complications Associated with Transvaginal Placement of Surgical Mesh .” U.S. Department of Health & Human Services, October 20, 2008. http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/PublicHealthNotifications/ucm061976.htm.
(3) FDA. “Boston Scientific Corporation Precision Twist Transvaginal Anchor System.” U.S. Department of Health & Human Services, February 12, 2009. https://accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1341777.
(4) FDA. “Coloplast A/S Supris Suprapubic Vaginal Mesh Sling.” U.S. Department of Health & Human Services, December 1, 2010. http://accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2166684.
(5) FDA. “MAUDE Adverse Event Report: Johnson & Johnson Uretex Synthetic Sling Transvaginal Mesh.” U.S. Department of Health & Human Services, October 2, 2011. http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=2302230&DEVICE_SEQUENCE_NO=2.
(6) CNN Money. “Boston Scientific accused of using counterfeit ingredients.” Turner Broadcasting , January 14, 2016. http://money.cnn.com/2016/01/14/news/companies/boston-scientific-vaginal-mesh/.
(7) Fox News Health. “For vaginal repair, benefits of mesh must be weighed against harms.” Fox News Network, LLC, February 17, 2016. http://www.foxnews.com/health/2016/02/17/for-vaginal-repair-benefits-mesh-must-be-weighed-against-harms.html.
(8) ABC News. “Injured Women Sue Johnson & Johnson Over Vaginal Mesh Product.” ABC News Network, September 9, 2011. http://a.abcnews.com/Health/WomensHealth/johnson-johnson-sued-vaginal-mesh-product/story?id=14473688.
(9) U.S. Food & Drug Administration. “UPDATE on Serious Complications Associated with Transvaginal Placement of Surgical Mesh for Pelvic Organ Prolapse.” U.S. Department of Health & Human Services, July 13, 2011. http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm262435.htm.
(10) FDA. “FDA issues proposals to address risks associated with surgical mesh for transvaginal repair of pelvic organ prolapse.” U.S. Department of Health and Human Services, April 29, 2015. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm395192.htm.