Polypropylene developed in the 1950's as a thermoplastic polymer resin of propylene is made from petroleum. It can be molded or extruded into several forms which include suture material and specially produced mesh and nonwoven polypropylene fabric.
Polypropylene Knitted Mesh (PPKM) fabrics are comprised of monofilament yarns, which are engineered for the manufacturing of textile factors. Nonwoven polypropylene fabric has been used for similar applications. Problems have led to warnings being issued for various products made of nonwoven materials and in some cases manufacturers have stopped making the products. Medical applications include hernia mesh patches, stress urinary incontinence (SUI) slings, and vaginal prolapse suspenders.
There have been two common issues affecting woman for many years. They are pelvic organ prolapse and stress urinary incontinence. The pelvic floor also helps support and stabilize other organs keeping them in place. Adult women will experience varying stages of SUI during their lifetime with some form of complications ranging from occasional leakage whether minimally or complete loss of urine. Although nonsurgical methods such as dietary changes, bladder retaining, Kegel exercises, biofeedback, pessaries, electrostimulation, and drug therapies have been used successfully, many patients eventually require surgical relieve of their symptoms.
In an attempt to provide medically safe and effective treatment, several companies have manufactured products for the management of these conditions and to alleviate the pain, and discomfort of the every day complications these women suffer. Correction of these problems have been attempted through the use of a transvaginal mesh patch. The surgically implanted device stretches across the vaginal/pelvic wall providing added support to tissues damaged during an injury, childbirth and/or surgery. One of these products recently being criticized is Bard Avaulta Mesh, a product surgically implanted, and commonly referred to as a bladder sling. Historically, and for decades, the Kelley placation or the Marshal-Marchetti (Krantz) procedures have been the main surgical procedures for reinforcing the bladder neck to prevent unintentional urine loss.
On October 20, 2008, the Food and Drug Administration (FDA) issued a Public Notice warning consumers and health practitioners about serious complications associated with transvaginal placement of surgical mesh used to treat Pelvic Organ Prolapse (POP) and Stress Urinary Incontinence (SUI). The FDA said mesh placement procedures are typically considered to be minimally invasive however, for those affected by the following complications, there is nothing minimally invasive about the product.
The FDA remarked that during the past three years, it has received more than 1,000 reports from nine surgical mesh manufacturers of complications that were associated with surgical mesh devices used to repair these two medical conditions. These surgical mesh devices are typically transvaginal (through the vaginal wall).
The most frequently reported transvaginal surgical mesh complications reported to the FDA have included:
- erosion through vaginal epithelium
- urinary problems
- recurrent of prolapse and/or incontinence
Additional reports of bowel, bladder and blood vessel perforation occurring during insertion of the mesh have also been provided to the FDA. In some instances, mesh shrinkage or migration, granuloma formation, neuropathic pain, fistulas and dyspareunia from vaginal scarring and surgical mesh erosion led to significant decrease in the patient's quality of life.
The FDA has not yet determined whether specific characteristics put some patients at an increased risk for transvaginal surgical mesh complications.
Contributing factors may include the patient's overall health, the surgical mesh material, the size and shape of the surgical mesh, the surgical technique used, or other procedures undertaken such as a hysterectomy and estrogen status.
Treatment of the various complications may require additional surgical procedures, possibly even to remove the mesh, IV therapy, blood transfusions, and drainage of hematomas or abscesses.
In order to better document these problems and other possible problems, the FDA is encouraging patients and physicians to report complications associated with the device. Complications can be reported to the FDA's MedWatch Adverse Event Reporting Program at www.fda.gov/MedWatch/report.htm. It is time for this device to be recalled.
FEDERAL DRUG ADMINISTRATION
To minimize the risks to patients, the FDA recommends that doctors:
- Fully inform patients about the risks and symptoms of possible complications
- Closely monitor patients for possible complications and side effects following the procedure
- Immediately remove the path, should a patient begin developing patch-related health problems.
The patient should take the time as with any surgical procedure to learn about the types of procedures available and, the complications. If you notice any health problems, advise your doctor and, when necessary seek emergency medical care to prevent further complications.
If you or a loved one has experienced any of these complications associated with transvaginal placement of a surgical mesh, including but not limited to, Avaulta surgical mesh, please contact our firm for a free consultation to determine if you may be entitled to compensation for your injuries.