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Transvaginal Mesh Overview
Surgical mesh, or transvaginal mesh, has been used to treat stress urinary incontinence and pelvic organ prolapse (POP). The purpose of it is to permanently reinforce the weakened vaginal wall to support the bladder, neck or urethra for repair of stress urinary incontinence or to support the wall for POP repair.
However, many patients have experienced serious issues with their transvaginal mesh.
FDA Guidance
In April 2019, the U.S. Food and Drug Administration (FDA) ordered the discontinuation of the sale and distribution of all surgical mesh intended for use in transvaginal repair surgeries. Manufacturers named in this notice were Coloplast and Boston Scientific. According to the FDA, the pre-market standard that is used to determine the effectiveness and safety of these devices has not yet been met.
Transvaginal Mesh Follow-Up Care
According to the FDA, women who have undergone surgery to receive transvaginal mesh for the treatment of their pelvic organ prolapse should continue to attend their medical appointments with their physicians. Those who are not having any symptoms or complications should continue with routine medical care, but those who have experienced unexplained medical problems should be prepared to consult with their doctor about options for treatment.
Animal-Derived Mesh
There are various types of materials used to manufacture surgical mesh. These synthetic materials can be non-absorbable, absorbable or a combination of both. Animal derived mesh is absorbable, made of skin and tested on animals that have been disinfected and then processed for use as an implanted device.
Non-absorbable mesh, however, remains in the body permanently and is often used as an alternative because absorbable mesh loses strength over time and may degrade. Patients are advised to ask their doctors about the type of mesh to be used in their surgeries so that they can be aware of possible side effects.
Transvaginal Mesh Lawsuits
An analysis published by the National Institute of Health found that the majority of legal claims associated with transvaginal mesh involved slings for stress urinary incontinence and began shortly after the FDA’s 2011 communication about the use of mesh for treating POP.
Women who began suffering from complications argue in their lawsuits against the mesh makers that the risks were known by those who created the devices, but that no appropriate warnings were included, making it impossible for patients and doctors to make informed decisions.
Transvaginal Mesh Complications
Some of the most common problems reported by patients who received transvaginal mesh include mesh poking through the vaginal skin, pain with intercourse, and pelvic pain, according to the Mayo Clinic. When complications emerge, the woman might not realize its due to the mesh. While some recovery time from surgery is normal, anyone who experiences side effects that continue weeks beyond, or become more serious, should talk to a doctor about next steps.
Sometimes, the physician will determine that the transvaginal mesh needs to be removed or replaced, requiring an additional procedure that comes with its own set of risks and potential complications.
