Complications

What is Transvaginal Mesh?

Urogynecologic surgical mesh or transvaginal meshes are widely used to repair damaged or weakened tissues. It is either made from a synthetic material or for an absorbable biologic material. When these devices are used in urogynecologic procedures, they are intended to be a permanent procedure. As FDA defines, TVM is “permanently implanted to reinforce the weakened vaginal wall to repair pelvic organ prolapse or to support the urethra to treat urinary incontinence.”

With 3.7 million meshes sold worldwide between 2005 and 2013, mesh insertion is one of the most common surgical procedures used to treat stress urinary incontinence (SUI) in women.  However, soon after the products were launched, there has been constant debate and scrutiny about the safety of these procedures. The concern about the defective TVM and vaginal mesh complications were soon reported in other countries such as Australia, Belgium, Canada, England, Israel, Italy, the Netherlands, Scotland, and Venezuela. Also, international court actions against mesh manufacturers were underway as well.

Pelvic Organ Prolapse (POP) and Stress Urinary Incontinence (SUI)

Pelvic organ prolapse (POP) is a condition which occurs when the tissue holding the pelvic organs in place grows weak, gets damaged or over stretched. This results in the pelvic organs to slip. As per the FDA, 30 to 50 percent of all women will experience POP in their lifetimes.

Stress urinary incontinence (SUI) is a condition in which there is involuntary release of urine during physical activities, including but not limited to coughing, laughing, exercising, and sneezing.

Unfortunately, this bladder sling devices, which were thought to be one of the remarkable medical products, were soon found to be linked with serious and life-threatening transvaginal mesh complications.

How often do complications occur?

A wide variety of studies by D. Barski and D.Y. Deng in BioMed Research International revealed the complication rate for mesh for transvaginal POP repair is about 15 to 25 percent.

Common problems with mesh for POP reported to FDA from 2005 to 2010 include:

COMPLICATIONS NUMBER OF REPORTS
Erosion 528
Pain 472
Infection 253
Bleeding 124
Dyspareunia (painful sex) 108
Organ perforation 88
Urinary problems 80
Vaginal scarring 43
Neuro-muscular problems 38
Recurrence 32

MAUDE (Manufacturer and User Facility Device Experience Database) had received 139,000 adverse event reports by January 31st, 2019, related to gynecological mesh implants. Of them, 69,000 were for POP mesh, and 393 patients could make it as per the data presented by CEO of Device Events and former FDA consultant Madris Tomes.

Mesh Erosion Is Most Common Complication

Erosion of mesh through the vagina is one of the most common transvaginal mesh complications. Vaginal rosion can be extremely painful, and usually makes intercourse equally difficult. The condition occurs when the defective implanted mesh wears through a woman’s internal tissues.

There are three types of internal complications caused by mesh erosion which includes:

  • Exposure: where the mesh can be seen through a tissue.
  • Extrusion: where the mesh protrudes out of a body structure or tissue.
  • Perforation: anomalous opening into an organ caused by mesh.

Not just the vagina, erosion can affect several other organs as well.  For instance, urinary tract erosion can result in recurring infections and severe pain. Erosion into the bladder or rectum are also reported in patients and can cause chronic infections, pain and abnormal connections called fistulas.

Some of the other vaginal mesh complications associated with mesh erosion include:

  • Abscesses (pus-filled sores)
  • Vaginal discharge
  • Vaginal scarring
  • Neuro-muscular problems

Some doctors have blamed the high rate of mesh erosion or exposure on the incompetency of surgeons. One of the other reasons why it is such a serious complication is that the rate of occurrence increases over time.

Pain After Mesh Implantation

Chronic pain is one of the chief problems women face after the implantation of the mesh. Studies revealed 70 out of 110 cases complained about pain.

While some women have uncomfortable symptoms from POP long before the mesh is implanted, many women report new pelvic pain, medically termed as de novo pain, after the surgery.

The immune system is also responsible for causing the pain symptoms, as shown in the published study of the American Journal of Obstetrics and Gynecology. Researchers found women with mesh had increased levels of collagen and T cells buildup. This makes the tissue less flexible results in a pulling force on nearby muscles and other body parts, causing pain.

Perforation of Multiple Organs

Organ perforation, as the term suggests, is defined as the penetration of the wall of any organ in the body. When the mesh starts eroding through the internal tissues, the debris of the mesh particles can perforate other organs. This usually affects the urethra, bladder, bowel or rectum. Doctors deem this as one of the most severe complications of mesh surgery as it leaves the patient susceptible to the risk of infection and organ damage.

Complication rates are significantly higher for the mesh perforation compared to the other possible side effects. Although rare, perforation can occur during implantation as well. This happens when surgical tools puncture the bowel, bladder or blood vessels. Women have reported of bladder wounds and rectal wound following the TVM implant surgery.

Removing mesh is the first treatment you need to undergo for any defective mesh implant. Surgeons reconstruct the mesh-injured tissues or cauterize (burn) ruptured blood vessels to stop the bleeding. Doctors use catheter or other devices to remove any leaked urine or fecal matter from the bladder or bowels. In the initial stage of the infection caused from perforation, antibiotics are prescribed. It might take multiple surgeries to remove the mesh completely.

Some other complications associated with the defective mesh implant includes but not limited to:

  • Unusual vaginal bleeding
  • Severe abdominal discomfort
  • Chronic pelvic pain
  • Pain during intercourse
  • Severe infections
  • Urinary incontinence
  • Return of pelvic organ prolapse

If you are among those who have suffered from these adverse health issues from faulty transvaginal mesh implantation, you owe it to yourself to consult with the reputable team experienced attorneys of SettleOurTVM.