Pelvic mesh implants are used for the treatment of pelvic organ prolapse, incontinence, and other pelvic disorders. A pelvic mesh or transvaginal mesh implant can help alleviate symptoms by securing pelvic organs in a sling. This alleviates pressure from the pelvic floor, which may help with symptoms of pelvic organ prolapse and incontinence.

What Is Pelvic Organ Prolapse?

Pelvic organ prolapse occurs when the pelvic floor muscles become unable to support the uterus, bladder, and/or rectum. This causes one or multiple organs to press into the vagina. In some cases, the pressure may cause tissues to bulge out of the vagina completely.

What Are Side Effects of Pelvic Mesh Implants?

Transvaginal mesh implant manufacturers have paid $8 billion to resolve claims that their devices are unsafe. Women who have filed lawsuits against the companies argue that the mesh implants are defective and cause pain, organ damage, infection, and incontinence.

As a result of the potential risks, the U.S. Food and Drug Administration (FDA) has restricted the sale of all transvaginal mesh products.

On April 16, 2019, the agency “ordered the manufacturers of all remaining surgical mesh products indicated for the transvaginal repair of pelvic organ prolapse (POP) to stop selling and distributing their products in the U.S. immediately.”

The FDA noted that this was part of a larger, ongoing effort to protect consumers from the risks of transvaginal mesh product defects. “The order is the latest in a series of escalating safety actions related to protecting the health of the thousands of women each year who undergo surgery transvaginally to repair POP,” according to the FDA.

The affected manufacturers, Boston Scientific and Coloplast, “have not demonstrated a reasonable assurance of safety and effectiveness for these devices,” the FDA news release stated.

Although the agency has taken action to stop the sale of the transvaginal mesh products, other pelvic mesh products remain on the market – specifically those marketed for treating incontinence.

Yale Medicineexplains that the FDA did not entirely ban pelvic mesh implants in prolapse surgery, and the distinction between what is banned and what is not has left some women confused.

According to Yale Medicine, the FDA banned the insertion of pelvic mesh through the vagina. This is known as a transvaginal mesh procedure and is used specifically to treat pelvic organ prolapse. In this procedure, an incision is made into the vaginal wall, through which the mesh is inserted. The goal of the surgery is for the patient’s tissue to grow inside the holes in the mesh, creating a wall to help support the organs.

Harvard Health reports that half of women over age 50 have pelvic organ prolapse. However, only about 3% to 8%  of women in the general population need intervention to treat their symptoms. In light of the FDA’s restriction on transvaginal mesh surgeries, Yale Medicine’s experts advise women who are not experiencing any issues following transvaginal mesh surgeries not to panic and instead speak to their doctor.

Yale’s experts also note that mesh is not always inserted transvaginally. The FDA’s restrictions do not apply to surgeries in which the mesh is implanted through the abdomen (as opposed to the vagina). Additionally, mesh is still permitted in stress urinary incontinence surgeries, known as sling procedures. According to Yale, stress urinary incontinence is more common than pelvic organ prolapse and affects around one in three women. Reportedly, these kinds of surgeries are well researched and deemed safe and effective.

The American Urogynecologic Society supports the use of pelvic mesh implants and says that the medical devices are “are a standard of care for the surgical treatment of stress urinary incontinence and represent a great advance in the treatment of this condition for our patients,” according to The Philadelphia Inquirer.

However, some women may not want to be treated with pelvic mesh products considering the bad press and recently uncovered risks associated with them.

Are There Other Treatment Options for Pelvic Organ Prolapse?

With the potentially risky side effects associated with pelvic mesh implants, some women may choose to forego the devices fr the treatment of pelvic organ prolapse. According to Cleveland Clinic, there are other treatment options.

Non-surgical treatment may include physical therapy exercises to strengthen the pelvic floor or the use of a pessary, a device inserted into the vagina to provide support to prolapsed organs, helping to relieve some of the pressure placed on the bladder and bowel.

Surgical options that don’t involve a transvaginal mesh product also exist. In some approaches, the upper vagina or cervix can be suspended from the ligaments in the pelvis. This serves a similar purpose as a transvaginal mesh implant but relies on the existing connections in the body to support the prolapsed organs.

In other cases, obliterative surgery may be recommended. In this procedure, the vaginal canal is partially or totally closed off. According to WebMD, this “may be an option if surgery hasn’t worked and you can’t tolerate another procedure. After this operation, you will no longer be able to have sexual intercourse.”

Filing a Transvaginal Mesh Lawsuit

More and more patients are reporting complications caused by transvaginal mesh devices.

Many lawsuits have been filed against manufacturers by women who have suffered pelvic mesh implant injuries. An Australian plaintiff who won her class action lawsuit against Johnson & Johnson in 2019 called the victory a validation. “It’s just horrifying that in this day and age that that can happen,” she told CNN. “And it has such devastating results for women.“

According to the lawsuit, Johnson & Johnson may have been aware of the potential dangers associated with its pelvic mesh but still continued to market it to doctors. At least 1,350 women who received pelvic mesh implants joined the lawsuit to pursue compensation and accountability from J&J.

Women who have been harmed by transvaginal mesh implants say the complications can be debilitating and life changing. Another plaintiff in a Johnson & Johnson class action lawsuit claimed that her pelvic mesh eroded and ultimately a sharp edge of the device began to puncture through the front wall of her vagina. In order to repair the damage, the woman had to undergo multiple surgeries and claims that she now suffers chronic pain as well as emotional distress. Other women have experienced recurrent infections, chronic incontinence, acute pain, sexual dysfunction, and internal injuries. One plaintiff commented that no amount of compensation from the lawsuit could make up for the pain and suffering she and the other class members have experienced from their pelvic mesh implants.

If you or someone you love has suffered side effects as a result of a transvaginal mesh product, you may be able to file a lawsuit and pursue compensation. Of course, filing a lawsuit cannot take away the pain and suffering, but it can at least help to alleviate the financial burden incurred by medical expenses, lost wages, and more.

Filing a lawsuit can be a daunting prospect, especially while dealing with these or other health issues, so Top Class Actions has laid the groundwork by connecting you with an experienced attorney. Consulting an attorney can help you determine if you have a claim, navigate the complexities of litigation, and maximize your potential compensation.