FDA Orders Manufacturers to Stop Selling Transvaginal Mesh

April 16, 2019, the United States Food and Drug Administration (FDA) published a press release that indicated it had officially and directly ordered all known major manufacturers of transvaginal surgical mesh to stop selling and distributing such products in the United States. The order was coupled with a press release from the FDA that specifically named Coloplast and Boston Scientific, two big-time manufacturers of transvaginal surgical mesh that are found in the United States, as having failed to properly demonstrate that such products were effective or safe to the government agency’s desired degree.

The FDA did share via its press release that mesh products intended for use in repairing pelvic organ prolapse cases requiring transvaginal work are no longer to be sold in the United States. However, the agency did not make any indications regarding other types of surgical mesh.

Although you’ve probably seen commercials for transvaginal mesh, also known as vaginal mesh or pelvic mesh, most people don’t know much about the product or its use in surgeries.

What is transvaginal mesh?

Transvaginal mesh is a type of pelvic mesh that is used specifically for repairing either the prolapse of the vagina, a type of pelvic organ prolapse, or stress urinary incontinence. Pelvic mesh, also known as surgical mesh, is used in place of or to strengthen existing tissues in the body that have weakened over time.

What is pelvic organ prolapse?

Vaginal prolapse is a condition in which this small organ stretches or expands into places it shouldn’t go. Here are a few of the most common symptoms associated with pelvic organ prolapse:

• Difficulty urinating or passing bowel movements.
• Bulging close to the vaginal opening.
• Sensations of pressure in the lower abdomen, pelvic area, or both.
• Urinary leakage or reduced pressure in urinary streams.
• Feelings of fullness, pressure, discomfort, or pain in these areas.
• Bleeding from the vaginal opening, usually found in women’s clothing, pads, or diapers.

This issue doesn’t necessarily have to be fixed for patients to live healthy lives. If a patient’s quality of life is good and not affected by pelvic organ prolapse, women shouldn’t worry about fixing it.

Common fixes for vaginal prolapse include making changes to women’s behavior, making better lifestyle choices, undergoing physical therapy, and inserting a specialized device known as a pessary.

What is stress urinary incontinence?

Urinary incontinence is a medical issue affecting both men and women that is defined by consistently passing urine outside of trips to the bathroom. One type of urinary incontinence is stress urinary incontinence, a condition in which people’s incontinence is caused by physical activity or movement, ranging from things like coughing or sneezing up to lifting heavy weights or running.

It’s important to note that stress urinary incontinence has nothing to do with psychological stress. This type of stress is solely in the physical sense.

People with stress urinary incontinence may leak urine when they have sexual intercourse, exercise, lift heavy objects, sit down, stand up, or laugh.

Treatments for stress urinary incontinence are largely the same as those for pelvic organ prolapse, though some treatments are specific to incontinence. These include modifying how much liquid patients drink and how often they do so, avoiding certain foods and drinks, engaging in bladder training, doing Kegel muscle exercises, and treating existing cases of bladder infection.

The second line of treatment involves surgery, most of which uses transvaginal mesh to fix these issues.

What steps do surgeries involving transvaginal mesh follow?

Sling procedures, as they’re known in medical terminology, are used to fix both stress urinary incontinence and pelvic organ prolapse. These procedures use strips sourced from either donor tissue, animal tissue, tissue from your own body, or synthetic mesh.

Sling procedures, which are carried out through the vaginal opening rather than the abdomen, involve forming a sling with the aforementioned strips under the urethra, the tube through which urine travels from the bladder. The sling can also be made under the bladder neck, which is an area of muscle that helps keep the urethra and bladder together. These strips help keep the urethra functioning as it normally should, or keep the vaginal wall’s tissues from protruding into areas where they shouldn’t be, or from bulging out of the vaginal opening.

Although this procedure is the last hope for some women dealing with pelvic organ prolapse issues, there are several potential complications that affect women who have undergone surgeries involving transvaginal applications of surgical mesh.

What are some of the most common issues women face from transvaginal mesh surgery?

Women sometimes face issues related to sexual intercourse as a result of vaginal mesh contracting or getting smaller over time. The vagina and surrounding areas can become infected as a result of transvaginal mesh, even if it was installed properly. Chronic pain and nerve damage can also result from the surgical implantation of transvaginal mesh.

KBA Attorneys help people suffering from the complications of vaginal prolapse surgery using transvaginal surgical mesh to seek compensation from medical providers or, most commonly, the manufacturers of transvaginal surgical mesh. These types of claims fall under the umbrella of personal injury suits, a common claim made in the courts of civil law. Contact us today or fill out our online application for a case evaluation.