The Dangers Of Transvaginal Mesh
It is not uncommon for women to experience pelvic organ prolapse or stress urinary incontinence as a result of childbearing, age, or a hysterectomy. With each of these conditions, the pelvic organs can slip out of place and be displaced into the vaginal canal. This condition is usually treated with surgery, using vaginal mesh to reinforce and keep the organs in their proper place.
Unfortunately, this mesh is causing serious side effects that cause pain, possible revision surgeries, and sky high medical costs. If you or a loved one has been injured because of the use of vaginal mesh, you could have a legal claim. Contact The Bradley Law Firm at 1-800-239-1764 for guidance and a free consultation.
What is Transvaginal Mesh?
Transvaginal mesh is a net like substance made from polypropylene. The term transvaginal refers to how the mesh is put in place. This substance is commonly used to correct pelvic organ prolapse (POP) and stress urinary incontinence (SUI). This product is also referred to as vaginal mesh, transvaginal tape, or a bladder sling.
Unfortunately, this mesh has proven to be unreliable. It is contended that the implantation techniques and the design have contributed to serious complications. These include erosion of the vaginal tissue, organ perforation and infection.
Some complications with transvaginal mesh include:
- Mesh erosion
- Pelvic pain
- Urinary incontinence
- Urinary retention
- Perforation of the bladder, bowel and blood vessels
- Neuropathic pain
History of Transvaginal Mesh
The use of this mesh substance has evolved from surgical mesh products used to correct hernias in the 1950s. Surgeons begin using mesh to repair prolapse and stress incontinence in the 1970s. The first transvaginal mesh product was approved by the Food and Drug Administration in 1996. These were originally sold as kits, including the tools to implant the mesh and instructions.
There are many manufacturers who make this product which include:
- Gynecare Prolift
- Johnson & Johnson
- R. Bard Avaulta
- American Medical Systems
What is Pelvic Organ Prolapse?
This condition occurs when the pelvic organs fall out of place because of weak pelvic muscles. The mesh provides a hammock like support to hold the organs up. While it can include the uterus, rectum and bowels, the bladder is usually the most affected.
What is Stress Urinary Incontinence?
SUI occurs where the bladder leaks urine during increased physical activity. The mesh is used to create a bladder sling that supports the bladder.
Although surgery for these conditions is far more common than it used to be, it also has a higher complication rate. The FDA reported that in 2011, they had received 4,000 reports of complications due to the use of transvaginal mesh.
The main complications that arise include tissue erosion and organ perforation. Because the mesh was created to remain in the body indefinitely, a revision surgery can be extremely difficult. Tissue and blood vessels grown around the mesh. When removal becomes necessary, it often has to be removed in pieces. Specialized doctors often need to be brought in, called urogynocologists.
Transvaginal Mesh and the FDA
Unfortunately, the FDA did not require that the mesh manufacturers conduct any human studies before the product was released into the market. Also, many new mesh products were based on a product called the ProtoGen Sling, which was recalled in 1999 due to a high rate of erosion.
In the Journal of Obstetrics and Gynecology, researchers found that more than 15% of patients who received the mesh experienced tissue erosion resulting in pain and infections. They stated, “Surgeons should be aware of the potential complications of synthetic meshes. Until data on the safety and efficacy of the intravaginal slingplasties are available, these procedures cannot be recommended.”
Are there any Transvaginal Mesh Lawsuits?
Thus far, over 65,000 cases have been filed against various manufacturers of the mesh products that include, C.R. Bard, Ethicon (part of Johnson and Johnson), American Medical Systems and Boston Scientific.
If you or a loved one has experienced problems with transvaginal mesh, speak to a defective drug lawyer from The Bradley Law Firm. You may be entitled to compensation for your medical expenses, lost income, loss of consortium as well as pain and suffering. We can answer your questions and explain what legal options are available to you.