Transvaginal Mesh Sale and Distribution Stopped by FDA

The United States Food and Drug Administration (FDA) published a press release on April 16th, 2019 that stated the sale and distribution of transvaginal surgical mesh within the United States was now banned, and that all major manufacturers had been officially and directly ordered to stop.

The press release from the FDA specifically named Boston Scientific and Coloplast, two large medical manufacturers located in the United States, that failed to correctly show that transvaginal mesh products were safe and effective for use up to government standards.

The FDA also shared within the press release that the products intended for use specifically in repairing pelvic organ prolapse cases that require transvaginal procedures are not to be sold in the United States. However, the FDA did not comment regarding other kinds of surgical mesh.

Most people don’t know much about the product or its use in surgeries, as these cases are very private. So what is transvaginal mesh and its medical use?


What is Transvaginal Mesh?

Transvaginal mesh is a type of pelvic mesh that was created to be used for a number of reasons, such as repairing either the prolapse of the vagina, a type of pelvic organ prolapse, or stress urinary incontinence. Pelvic mesh, which is also called surgical mesh, is used in the place of existing tissues that are not working properly, or to strengthen those existing tissues in the body that have been weakened over time.


Pelvic Organ Prolapse

Vaginal prolapse is a situation where this small organ internally stretches or expands into other areas. Here are some 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.

Luckily, this issue is not one that can put all afflicted patients in danger and many can work around the symptoms. If a patient’s quality of life is already high and not severely affected by pelvic organ prolapse, they shouldn’t worry about fixing it.

Common fixes for vaginal prolapse can include making changes to women’s behavior, such as making better lifestyle choices that may have led to the condition. Some undergo physical therapy for extended periods of time, while others insert a specialized device known as a pessary.


Stress Urinary Incontinence

Urinary incontinence, which affects both men and women, is defined by repeatedly passing urine outside of trips to the bathroom. A more specific type of urinary incontinence is stress urinary incontinence, a medical condition where people’s incontinence is caused by some kind of physical activity, ranging from things like coughing or sneezing up to lifting heavy weights or running.

An important distinction is that stress urinary incontinence has nothing to do with psychological stress. This type of stress is solely in the physical sense.

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

Many of the common treatments for stress urinary incontinence are the same as those for pelvic organ prolapse, though some treatments are specific to incontinence. This can include changing the volume of liquid patients consume and how often, avoiding certain foods and drinks, engaging in bladder training such as kegel muscle exercises, and treating existing cases of bladder infection.

The second line of treatment involves surgery, most of which utilize transvaginal mesh.


Surgery Involving Transvaginal Mesh

Surgeries to fix both stress urinary incontinence and pelvic organ prolapse are called sling procedures, which is the medical terminology. These procedures commonly use strips sourced from either donor tissue, animal tissue, tissue from your own body, or synthetic mesh.

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

This procedure is generally the last chance for some women in dealing with their pelvic organ prolapse issues. Although that may be important, there are severe complications that have affected women who have undergone surgeries involving transvaginal applications of surgical mesh, and can result in a worsening of the condition or new conditions entirely.


Common Issues Women Face From Transvaginal Mesh Surgery

Women sometimes face issues related to sexual intercourse as a result of vaginal mesh contracting 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.

The Eichholz Law Firm helps 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 lawsuits, a common claim made in the courts of civil law. Contact us or fill out our online application so we can advise you on your next steps.


References

  • FDA. “FDA takes action to protect women’s health, orders manufacturers of surgical mesh intended for transvaginal repair of pelvic organ prolapse to stop selling all devices”, U.S. Department of Health and Human Services, https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm636114.htm. Accessed April 18th, 2019.
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