FDA Announces Common Complications Associated With Vaginal Mesh Devices

The introduction of transvaginal mesh devices was supposed to be the latest innovation in the treatment of pelvic organ prolapse (POP) and stress urinary incontinence (SUI), two pelvic floor disorders that affect millions of women. 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 continuous pain and suffering 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:

 

Mesh Erosion/Exposure

 

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

 

Mesh erosion may occur just two weeks after an operation or in the case of erosion into the colon or rectum, it may manifest after a number of years. 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.

 

Persistent Pain (Including Dyspareunia)

 

Chronic pain and discomfort, in part due to the erosion of the mesh, may become a daily component of a patient’s misery. This pain can be very devastating that it will affect her ability to perform even the most mundane tasks. Doctors attribute this pain to the disruption or the entrapment of the nerve fibers, which may have been stimulated by the mesh.

 

The groin, buttocks, and almost all parts of the pelvic are the locations where pain may be felt. As reported by a majority of women, pain may also be experienced during sexual intercourse. Over 90 percent of patients were freed of pain and discomfort one the mesh was removed, based on the results of one study.

Serious Infections

 

Based on the reports of numerous patients, an infection after a vaginal mesh repair was one of the most common complications. A patient may subjected to great pain and discomfort that may affect her day to day activities as a result of these infections. It may become very difficult for a woman to sit or stand and walking will be impossible without medications.

 

A patient may be at risk of suffering septic shock, a life-threatening condition, if these infections get worse. The deadly septic shock occurs when serious symptoms appear in the patient’s entire body after an infection spreads to the blood.

 

Recurrent Prolapse or Incontinence

 

It is not uncommon to see patients developing incontinence and other urinary problems after a procedure involving the transvaginal mesh repair of an organ that has prolapsed. The need for frequent urination, urinary tract infections, difficulty in urinating, and leakage when pressure is exerted on the abdominal area are the indications of this complication. A woman may find it very frustrating that she now has to deal with other forms of pelvic floor disorders after having undergone surgery to treat a similar condition.

 

Other Severe Complications

 

While the most common complications are those mentioned above, patients may also be at risk of other adverse effects that may be equally dangerous. There may be heavy bleeding, organ perforation, mesh shrinkage, neuro-muscular damage, constipation, and even emotional problems.

 

All these complications can be very dangerous that thousands of women have sustained serious injuries leading to pain and suffering, permanent disability, and even substantial deformity. As a result of these injuries, thousands of women have been compelled to take legal steps such as filing of vaginal mesh lawsuits against mesh manufacturers. Hearings of these claims have been scheduled in courts with the upcoming bellwether trials in West Virginia foreseen to have significant implications on the pending vaginal mesh lawsuits.

 

Reference:

fda.gov

c.ymcdn.com

meshsurgeons.com

 

hindawi.com

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