The FDA approved the first transvaginal mesh product in 1996. Transvaginal mesh is intended to provide a permanent solution for patients experiencing stress urinary incontinence (SUI) and pelvic organ prolapse (POP). Stress urinary incontinence is the leakage of urine during normal physical activities, especially coughing or sneezing. Pelvic organ prolapse is a condition in which the tissues holding the pelvic organs become weak or stretched. As a result, the organs bulge into or past the vaginal opening. This can happen after a hysterectomy, giving birth, or during menopause.
The original transvaginal mesh device was called ProteGen, and was manufactured by Boston Scientific Corporation. ProteGen was approved using the FDA’s 510(k) Approval Process. This process is used to quickly move a product to market when it is believed that it fills a medical need for which there are currently no sufficient alternatives. The 510(k) approval process only required that the transvaginal mesh be similar to mesh that was being used in other surgical procedures at the time.
ProteGen stayed on the market for three years. During that time, a number of other companies introduced transvaginal mesh products. The FDA used the same approval process with those products, this time gauging the products’ similarities to ProteGen. A number of alarming side effects have arisen in the years since the first transvaginal mesh was implanted. These side effects include organ perforation and erosion of soft tissues.
Transvaginal Mesh FDA Warning
In response to the growing number of reported complications from transvaginal mesh implants, the FDA issued its first public health notification on October 20, 2008. This notification stated that there were over one thousand cases of adverse effects occurring as a result of transvaginal mesh procedures.
Reported complications include:
- Bowel or bladder perforation
- Vaginal scarring
- Mesh erosion inside the body
- Dyspareunia (pain during sex)
Updated Transvaginal Mesh FDA Warning
In January of 2011, the FDA updated this warning to inform the public that these issues are not rare. Almost three thousand more cases were reported between 2008 and 2011. These also included many cases of recurrence of pelvic organ prolapse (POP) and stress urinary incontinence (SUI), even some cases in which the patient was treated for POP and developed SUI as a result of the surgery.
The FDA launched a systematic review of all of the published scientific literature from 1996 through 2011 to determine the safety and effectiveness of transvaginal mesh. This review revealed that neither quality of life nor effectiveness of treating symptoms is improved by using transvaginal mesh over traditional non-mesh repairs.
The FDA findings also stated:
- Using mesh introduces problems not present in traditional non-mesh surgeries
- Mesh inserted through the abdomen for POP repairs did not pose the same risks as mesh implanted transvaginally
- There is no evidence that using mesh to reinforce the top of the vagina or the back wall of the vagina increases the effectiveness over traditional surgeries without mesh
- A previously unidentified risk called mesh contraction, resulting in vaginal shortening, vaginal tightening, and vaginal pain
- Mesh erosion is the most common complication arising from transvaginal mesh surgery to treat POP
Transvaginal Mesh Revision Surgery
In the case of mesh erosion, the only way to remove the transvaginal mesh is through revision surgery. This can be painful, difficult, and in some cases impossible. The mesh begins to fuse with the patient’s tissues and organs and must be removed piece by piece as it is visible to the surgeons. It is often required to undergo numerous surgeries to remove all of the pieces when the mesh had begun to erode.
In some cases, the surgeons are not able to successfully find and remove all pieces of mesh. The surgery also carries its own risks, such as pain during intercourse, excessive bleeding, urinary incontinence, and damage to the bladder, bowel, and other organs.
FDA Recommendations for Health Care Providers
In concurrence with the original FDA warning set forth in 2008, the FDA continues to recommend that health care providers form the first line of defense against complications arising from transvaginal mesh surgery by being aware of risks and benefits.
Health care providers should:
- Complete specialized training for mesh placement
- Be watchful for adverse effects from the mesh, especially erosion and infection
- Inform patients that mesh is permanent, once implanted it may not be possible to remove
- Inform patients about the possibility of adverse effects on quality of life, including pain during sexual intercourse
- Be aware that in most cases, mesh is not required and all complications can be avoided by not using it
- Be aware that placing mesh abdominally may lower the risk of complications when compared to transvaginally
- Notify the patient if mesh will be used and provide information on the specific product to be used