FDA Announces Common Complications Associated With Vaginal Mesh Devices

March 4, 2014

When the transvaginal mesh devices were introduced as treatment for pelvic organ prolapse (POP) and stress urinary incontinence (SUI), it was regarded by many as the latest innovation in this medical field. Now, thousands of women have been exposed to grave danger just because they have been convinced to use these mesh devices to treat disorders that were not considered life-threatening. These women right now face endless pain and misery as a result of severe complications instead of improving their quality of life.

 

Common complications associated with the use of vaginal mesh devices include the following:

 

Erosion of Mesh

 

Mesh erosion may be the most serious among the many possible adverse effects aside from being the most common. If the mesh erodes into the bladder or rectum, there will be terrible pain in the affected areas, blood in the urine and stool, recurrent urinary tract infections, urinary incontinence, fistula formation, abscess formation in the vagina, and possible infections in multiple organs of the body. A surgery to remove the mesh, in most cases, may be required without a guarantee that all the mesh will be removed.

 

Erosion of mesh may be experienced by a patient just two weeks after the surgery or it may manifest only after a number of years, particularly in the case of mesh erosion into the colon or rectum. In a number of instances, it is only during sexual intercourse, when the woman or her partner feels great pain during penetration, that mesh erosion may be detected.

 

Pain and Discomfort (Including Dyspareunia)

 

In part due to the erosion of the mesh, chronic pain may become a daily component of a patient’s misery. This pain and discomfort, which has been described as devastating, may affect a woman’s ability to perform even the most mundane tasks. Due to the stimulation by the mesh, nerve fibers may be disrupted or entrapped causing this pain, as explained by medical experts.

 

Pain may be felt in the groin, buttocks, and almost all parts of the pelvic area. Majority of women have also reported experiencing great pain during sexual contact. One study revealed that over 90 percent of patients were freed of any pain once the mesh was removed.

Serious Infections

 

Based on the reports of numerous patients, an infection after a vaginal mesh repair was one of the most common complications. In addition to the severe pain a patient may encounter, there is also a general discomfort that affects a woman’s day to day activities. It may become very difficult for a woman to sit or stand and walking will be impossible without medications.

 

When these infections worsen, a patient may be at risk of suffering septic shock which can be life-threatening if not immediately attended to. This occurs when the infection spreads into the blood causing serious symptoms to appear in the patient’s whole body.

 

Recurrence of POP or SUI

 

To see patients developing incontinence and other urinary problems after a procedure involving the transvaginal mesh repair of an organ that has prolapsed is not entirely uncommon. Symptoms may include urinary tract infections, difficulty in urinating, the need for frequent urinations and leakage when the abdominal area is stressed. This can be very frustrating to women who now have to deal with other forms of organ prolapse or a recurrence of incontinence after having to undergo surgery to repair a POP or SUI.

 

Other Adverse Effects

 

Patients may also experience other severe side effects that may be as equally dangerous as the common complications mentioned earlier. Other severe complications may be manifested in the form of mesh shrinkage, organ perforation, neuro-muscular damage, heavy bleeding, constipation, and even emotional problems.

 

Thousands of women have sustained serious injuries leading to pain and suffering, permanent disability, and substantial deformity due these very dangerous complications. These have compelled them to take legal actions such as filing of vaginal mesh lawsuits against mesh manufacturers. Trials for these claims may go full steam this year with the results of these hearings expected to have an impact on the pending 42,800 claims in West Virginia.

 

Reference:

fda.gov

c.ymcdn.com

meshsurgeons.com

 

hindawi.com

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