Complications and Side Effects
It may take just a few weeks or perhaps several months, but injuries that result from vaginally inserted pelvic mesh can lead to overwhelming pain, uncontrollable bleeding, infection and organ perforation.
For years, pelvic mesh has been used in women to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI). The mesh is supposed to support fallen organs and relieve the associated discomfort. Instead, pelvic mesh has been found to create multiple problems that can leave injured women incapacitated, unable to stand or sit for any period of time.
Pelvic Mesh Complications
When the U.S. Food and Drug Administration (FDA) initially started hearing about the problems in 2008, the agency was quick to say the complications – including chronic pain, adhesions and nerve- and blood-vessel damage – were rare. By 2011, the agency reversed its decision and declared the complications “not rare.” The FDA pointed out that women suffer from mesh erosion and mesh contraction, both of which can cause ongoing pain. Some of the other complications are equally painful:
- Perforated internal organs
- Frequent urinary tract infections
- Surgical removal of the device
- Vaginal scarring
- Neuro-muscular problems
Pelvic Mesh Adverse Events
In 2011, an FDA-sanctioned panel recommended the device be reclassified from a Class II to a Class III device, which would require rigorous premarket testing and trials. To date, no changes have been made.
Complications On The Rise
At the same time, the FDA has been closely watching its FDA Adverse Event Reporting System (FAERS), a database that tracks serious and life-threatening problems with medications and devices. Initially, the agency said that 1,371 SUI patients who underwent pelvic-mesh surgery from January 2008 to September 2011 reported complications. In a recently released report, the agency updated those figures to say there were 1,876 reported complications in a similar time frame, representing a marked increase in the number of reported injuries.
Significant SUI Injuries
The FDA went on to say there were 250,000 pelvic mesh surgeries in 2010 alone. The FDA’s adverse-events reporting system found that in SUI procedures there were a number of problems:
- Mesh slings that are inserted through the vagina create dangers not seen in other types of mesh surgery.
- Mesh erosion is the most commonly reported problem.
- Complications are not associated with one particular brand.
Pelvic Mesh Problems and Solutions
Often, physicians will attempt to treat eroded mesh using estrogen cream that is applied inside the vagina. The idea is that the estrogen will help plump the tissue and the eroded shards will be better absorbed. This is only a temporary fix, if at all. Instead, many patients have been forced to go back under the knife for additional surgical procedures.
Notable Revision Surgery Doctors
There are only a few doctors nationwide that are known for expertise in this area, including Dr. Shlomo Raz from the University of California. These procedures can be time consuming and costly; some patients have reported having up to two-dozen surgeries before being declared free of the mesh.
Paying For Your Procedure
Injured women and their families are being urged to consider a lawsuit to cover the cost of the revision surgery and all of the incidentals that go with it, including transportation costs, prescriptions and other medical consultations. The funds recovered from a pelvic mesh lawsuit can also help as you recover from your surgery and compensate you for your pain and suffering.