Transvaginal Mesh and the FDA Shutdown
Legally Reviewed and Edited by: Terry Cochran
In April 2019, the FDA stopped all production and sales of Transvaginal Mesh because it was found to create complications for women who are aging or may have had a hysterectomy or just given birth. The mesh product was initially used in the 1950s to repair hernia problems and use gradually expanded to include the treatment of Pelvic Organ Prolapse (POP). Currently, there are 0ver 4,000 vaginal mesh lawsuits involving the mesh implants, and more are on the horizon.
The use of the mesh implant solved many issues for women whose muscles and ligaments had weakened enough that there was the dropping of the cervix, bladder, rectum, or uterus. This condition occurs in at least two-thirds of women and can cause swelling or a feeling of pressure coming out of the vagina, incontinence, trouble urinating, or discomfort when having sex. Unfortunately, many women let this condition go untreated and experience many years of discomfort.
What is a Transvaginal Mesh Procedure?
Transvaginal Mesh is a net-like material that is placed in the abdomen and is like a hammock to prevent other organs from falling into the vaginal canal, causing discomfort and other problems. The mesh is inserted through the vagina with a surgical procedure, and thus the term “Transvaginal” is used to describe the operation.
Depending on the organs involved, the surgeons will place the mesh on the top or side of the vagina wall, and the size of the mesh will vary according to the calculations of the physician.
Another method for prolapse treatment and mesh insertion is called vaginal vault prolapse. This method is used primarily for a woman who has just had a hysterectomy and when the vagina collapses because the uterus has been removed. The surgeon will attach the mesh to the top of the vagina and sew it into the surrounding tissues.
The mesh material is usually made using a plastic known as polypropylene, or sometimes animal tissue is used. These materials have been used successfully in men for hernia repair, but it is the location of the mesh around the vagina that seems to create the most problems.
The placement of the mesh is critical to the success of the procedure, and if it is not integrated with the tissue walls correctly the area may never heal. Even the size of the original incision can be a factor in the healing process.
Treatment of Pelvic Organ Prolapse
Although thousands of women have filed lawsuits concerning the complications caused by the mesh implants, many professional organizations such as the American Urogynecological Society continue to stand by the use of mesh for the treatment of POP. Others who have been harmed by the device want it banned from all use. The debate continues. The outcomes of the vaginal mesh lawsuits may influence this debate. If you have had a mesh implant and are experiencing a problem, it is best to contact a medical malpractice attorney at our law firm to review your situation.
There are other treatments available for Pelvic Organ Prolapse using methods that do not involve Transvaginal Mesh implants. However, many physicians have seen success with this method and continue to promote the use of mesh in some cases.
If you have had this surgery or are considering a medical solution to a similar problem, you should consult your physician as soon as possible. If you are seeking legal advice, contact Eileen Kroll who is a registered nurse as well as a personal injury attorney with the Law Offices of Cochran, Kroll & Associates, P.C. for a free consultation. You can contact Eileen at Cochranlaw.com or call her directly at 866-MICH-LAW.
Disclaimer : The information provided is general and not for legal advice. The blogs are not intended to provide legal counsel and no attorney-client relationship is created nor intended.