Woman having pelvic pain from Vaginal Mesh

Vaginal Mesh (also known as transvaginal mesh) is used to treat women with pelvic organ prolapse (POP) or stress urinary incontinence (SUI) by lifting and supporting the weight of the bladder, uterus, or rectum. Despite being an effective means to treat POP and SUI in women, a number of medical studies have linked vaginal mesh to a list of serious medical side effects such as transvaginal erosion, nerve damage, organ perforation, and corrective surgeries.

Serious Side Effects

In (2)January 2016, Drugs.com published an article linking a range of serious and sometimes fatal side effects to vaginal mesh. According to the article, people who had been implanted with vaginal mesh reported complications and medical issues associated with transvaginal erosion and nerve damage. In (3)August 2014, U.S. National Library of Medicine published a medical review adding organ perforation and corrective surgeries to the list.

Some of the most serious side effects associated with the mesh implants include:

  • Transvaginal Erosion
  • Nerve Damage
  • Organ Perforation
  • Corrective Surgeries

Vaginal Mesh Erosion

In (4)March 2003, the FDA published an article linking vaginal mesh to the increased risk of transvaginal 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).

Symptoms related to transvaginal erosion include:

  • Difficulty urinating
  • Infections near the mesh
  • Severe pelvic pain
  • Urinary tract problems
  • Damage to nearby organs

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. Level of disability resulting from transvaginal erosion can be reduced with appropriate medical attention.

Vaginal Mesh & Nerve Damage

In (5)October 2014, the FDA released a Safety Communication linking vaginal mesh products to the increased risk of nerve damage. According to the Safety Communication, erosion of the mesh and scarring of the vagina led to nerve damage, discomfort and pain, including pain during sexual intercourse. Some patients needed additional surgery to remove the mesh that had eroded into the vagina and created more nerve damage.

Symptoms related to vaginal mesh induced nerve damage include:

  • Burning feelings
  • Numbness
  • Increased sensitivity
  • Stabbing pain
  • Constipation

There is no single classification system that can describe all the many variations of nerve injury. Damage can occur to nerves in your brain and spinal cord. It can also occur in the peripheral nerves, which are located throughout the rest of your body. Survival rate and quality of life after being diagnosed with nerve damage can be greatly increased with early detection and appropriate medical attention.

Vaginal Mesh & Organ Perforation

In (6)February 2009, the FDA produced an Adverse Event Report linking vaginal mesh to the increased risk of organ perforation, the penetration of the wall of a 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.

Symptoms related to vaginal mesh induced organ perforation include:

  • Pelvic pain
  • Vaginal bleeding
  • Infection around mesh
  • Urinary problems
  • Pain during intercourse

In research reviewed by the FDA ten percent of women treated with TVM to correct POP faced severe and life changing complications within one year of the surgery. A number of women have been told misleading information about mesh being safe, including that it is only mesh for POP, and not for SUI that is causing complications. This is not true. Death rate and level of disability resulting from organ perforation can be reduced with immediate and appropriate medical attention.

Corrective Surgeries Among Vaginal Mesh Patients

In (7)December 2010, the FDA published an Adverse Event Report linking TVM Mesh to the increased risk of corrective surgeries, recurring surgeries necessary to address adverse effects caused by the surgical mesh. According to the report, the patient began having problems with severe pain and bleeding because of mesh erosion in her vagina. She went through surgery twice to remove the mesh that was exposed. To date, she is still in constant pain, still bleeding heavily, and now has additional problems such as loss of bowel control and painful urination.

Reasons for corrective surgeries include:

  • Recurrence of prolapse or incontinence
  • Neuro-muscular problems
  • Severe pelvic or groin pain
  • Nerve damage
  • Urinary tract infections

The FDA issued an additional safety alert in which it cautioned that at least ten percent of women treated with vaginal mesh for POP or SUI experienced movement of the product or erosion during the first year after surgery. Half of those patients were forced to undergo corrective surgery to take out the mesh.

Other Side Effects

Vaginal mesh has been linked to other less serious, yet still painful and uncomfortable side effects. In (8)October 2011, the FDA released an Adverse Event Report, listing some of those side effects to include:

  • Relapse of POP & SUI
  • Urinary incontinence
  • Vaginal scarring
  • Sexual dysfunction
  • Urinary tract infection

As stated in the Adverse Event Report, The increased risk of any of the side effects listed above may occur with any type of Class II treatment. Women using vaginal mesh who develop any symptoms of any type of side effect or abnormality should notify their doctor immediately.

Has Vaginal Mesh Been Recalled?

Despite being associated with transvaginal erosion, nerve damage, organ perforation and corrective surgeries, vaginal mesh has not been the subject of a recall. However, some consumer advoicate orginizations such as Public CItizen have petitioned the FDA to discontinue the use of these dangerous products.  In Addition, in (9)April 2015, the FDA published a News Release which more or less questioned whether vaginal mesh products were more effective than tradition pelvic repairs, which come with far fewer risks of complications.

Unfortunately, as TVM Mesh becomes a more popular choice for treating pelvic organ prolapse (POP) or stress urinary incontinence (SUI), the likelihood of more people suffering from its side effects also increases.

SOURCES

(1) Approval – 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.

(2) Side Effects – Drugs.com. “Transvaginal mesh complications: Get the facts.” Drugsite Trust, January 17th, 2016. http://drugs.com/mca/transvaginal-mesh-complications-get-the-facts.

(3) Side Effects – U.S. National Library of Medicine. “Pelvic Support Problems.” National Institutes of Health, August 12, 2014. https://nlm.nih.gov/medlineplus/pelvicsupportproblems.html.

(4) Transvaginal Erosion – 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.

(5) Nerve Damage – FDA. “Surgical Mesh: FDA Safety Communication.” U.S. Department of Health & Human Services, October 6, 2014. http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm142636.htm.

(6) Organ Perforation – 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.

(7) Corrective Surgeries – FDA. “Coloplast A/S Supris Suprapubic Vaginal Mesh Sling.” U.S. Department of Health & Human Services, December 1, 2010. http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2166684.

(8) Other Effects – FDA. “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.

(9) Recall News – 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.

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