Vaginal mesh has been causing problems for patients for some time now. Recently, a panel provided the FDA with suggestions for assessing the safety and efficacy of this commonly used medical product.
According to the panel, evaluations of surgical mesh products should focus on several factors. There are only three vaginal mesh products on the market today, including Coloplast’s Restorelle DiretFix Anterior, and Boston Scientific’s Uphold Lite and Xenform.
Vaginal mesh products have been a concern in the medical community for years and were eventually re-classified as high-risk class 3 devices in 2016. There have been numerous adverse reactions reported to the FDA and many instances in which complications proved fatal.
The panel’s recommendations will help the FDA determine what to do with post-market data concerning the three products still on the market.
Long-term Evaluation Necessary to Determine the Efficacy of Vaginal Mesh
The panel’s recommendations were based on presentations from mesh manufacturers, testimonials from patients, and statements from three governing bodies in the industry, including the American College of Obstetricians and Gynecologists.
One of the primary concerns of the panel was how to evaluate the efficacy and safety of devices, especially in comparison to other treatment options. Most agreed that vaginal mesh must be shown to be of superior efficacy to justify the risks involved in its use.
They also pointed out that results should be evaluated up to 24 months after the procedure is complete because a major factor in mesh repairs is durability.
The panel also considered how much weight should be placed on what it called “subjective” outcomes reported by patients. The panel ultimately agreed that a certain amount of attention should be paid to both objective and subjective outcomes, but that these outcomes be given different weight in the FDA’s final analysis.
Additional Risks Associated with Vaginal Mesh
Known safety risks associated with vaginal mesh products include:
- Pelvic pain
- Erosion and/or exposure of mesh device
- Shortening of the vagina
- Unusual vaginal discharge
- Neuromuscular problems
- Vaginal scarring
- Bladder and vaginal bleeding
- Formation of fistulas
The panel recommended that complications that occur during the operation be added to this list, but believes pain and how it impacts a patient’s quality of life should be the most important factor for evaluation.
Training and Experience of Surgeon Likely Plays Role in Vaginal Mesh Outcomes
The panel also concluded that surgeon training and experience be evaluated because of the effect this could have on patient outcomes regardless of the actual safety of the device. The group recommended data be gathered regarding this and included in any evaluation by the FDA. In addition to surgeon experience and training, the panel also recommended pre-existing patient conditions such as obesity and connective tissue disease be taken into consideration.
Finally, the panel recommended the question “Would you do this procedure again?” be presented to those who have undergone vaginal mesh procedures and the answer be heavily weighted in the FDA’s analysis of the device.
There is no requirement for the FDA to follow the panel’s recommendations but it often does when evaluating a product.
Ultimately, these recommendations could determine if all vaginal mesh products are banned from use. Unfortunately, it does little to help those who have undergone procedures and are now experiencing complications. In many cases, follow-up procedures are needed to correct problems and remove mesh devices. Some women have been unable to gain relief from follow-up surgeries and must now live with chronic pain and ongoing complications from their mesh devices.
Notwithstanding claims relating to this product, the drug/medical device remains approved by the U.S. FDA.