What Is A Transvaginal Mesh?
The term “transvaginal” means “through the vagina”. Also known as a vaginal tape, sling or patch, a transvaginal mesh implant is a surgical mesh device which is used to treat urinary incontinence and pelvic organ prolapse in women.
Weak pelvic floor muscles cause suffering to millions of women in the United States. The pelvic floor can be weakened by aging, childbirth or other factors and this can lead to difficult medical problems. This has been happening to women for hundreds of years and medical advancements are progressing all the time. The transvaginal mesh was hailed when it was first introduced but since its introduction it seems to do more harm than good.
Transvaginal Mesh Complications
There have been a number of transvaginal mesh complications reported and the following were included:
- Vaginal Scarring
- Erosion of the mesh into the vagina, uterus, intestines and the bladder
- Fistulas (an abnormal connection between a vessel, organ, or intestine and another structure) and recurrence of prolapsed organs
- Blood vessel, bladder and bowel perforation caused by insertion
- Dyspareunia (pain during sexual intercourse)
- Urinary retention development
- Neuropathic or pelvic pain
- Incontinence and other urinary problems
Transvaginal mesh or vaginal sling surgery is intended to strengthen the woman’s internal organs and stop them from making contact with each other by means of the mesh tape. The Food and Drug Administration (FDA) have received more than a thousand trans vaginal mesh complaints from 9 different manufacturers since 2005 which has lead them to publish a safety alert describing the serious problems that can occur through the use of mesh products in 2008. A number of surgical procedures have been performed to remove the mesh from women that were experiencing problems. Another safety alert was issued by the FDA in 2009.
The manufacturers of transvaginal mesh devices were mandated by the FDA to investigate the risks posed to users of their products in 2012. The number of serious side effects from transvaginal mesh products had increased 5 times between the years 2008 and 2010 according to the FDA. Surgical mesh products that were implanted through the abdomen were not part of the FDA’s mandate.
The treatment of pelvic organ prolapsed with transvaginal mesh surgery was shown to have more risks than other surgical procedures according to the FDA in 2011. The FDA made clear that this did not apply to a mesh that was implanted abdominally or that this related to the treatment of stress urinary incontinence. The safety and effectiveness of these procedures was to be discussed by another advisory committee.
Prior to the approval of the transvaginal mesh, pelvic organ prolapsed and stress urinary incontinence were tackled using a procedure known as abdominal sacrocpopexy and there was no mesh involved. The procedure relied upon the support of the weakened muscles to come from the patient’s own ligaments. With transvaginal mesh surgery, a support sling is created by weaving the mesh through the pelvic tissue and placing it underneath the urethra thereby supporting the urethra when pressure is applied. In a number of transvaginal mesh lawsuits, it was claimed that the manufacturers had failed to warn of the serious risks involved and that expected safety standards had not been met. It was the view of some in the industry that the design of the mesh was defective and that the main complications present themselves because nutrients are prevented from being received by surrounding tissue. They also stated that the mesh can shrink or migrate and also erode into the vagina causing infections, pelvic pain and urinary complications.
It was found that more than fifteen percent of women that had undergone transvaginal mesh surgery had experienced erosion of the mesh leading to infections and pain according to an October 2005 review in The Journal Obstetrics and Gynecology. It was clearly stated in the study that the potential complications of synthetic meshes should be known by surgeons and that the transvaginal mesh procedures could not be recommended until further efficiency and safety data had been established.
A number of patients have undergone additional surgery to remove a mesh and have had to have blood transfusions, draining of abscesses and IV therapy.
Transvaginal Mesh Lawsuits
There have been a number of product liability lawsuits filed against the manufacturers of transvaginal mesh products including American Medical Systems, Bard, Boston Scientific and a subsidiary of Johnson & Johnson named Ethicon. The main claim in the lawsuits is that the transvaginal mesh were incorrectly designed leading to many serious side effects.
If you or a member of your family have had a transvaginal mesh implant and suffered complications from this then you may be entitled to compensation. You need to discuss this with competent transvaginal mesh lawyers who will want to discuss several aspects of your case before deciding whether to go ahead with a mesh implant lawsuit. You can start the process here. Only experienced transvaginal mesh attorneys can make the decision as to whether your surgical mesh lawsuit will stand up in court so make sure that you consult with them.