Bladder Sling Lawsuits

by Steve Fields on October 14th, 2011

Women suffering from surgery mesh complications have started filing bladder sling lawsuits due to the ongoing problems they are having including surgery mesh removal and ongoing pain and suffering. Surgical mesh was originally designed to treat hernias. But the product evolved over time, opening the door to other applications. Physicians began to use it as a treatment for pelvic organ prolapse (POP) starting in the 1970s. Back then, the device was implanted via abdominal surgery. Today, surgical mesh is implanted transvaginally as a minimally-invasive alternative to traditional methods. Unfortunately, this has led to numerous bladder sling complications, some of which may be untreatable.

Although more than 75,000 women undergo transvaginal placement of surgical mesh for POP repair each year, there are many questions regarding the risks. We’ll address several of them below to help you decide whether you should file a vaginal mesh lawsuit claim for any injuries you have suffered.

What Is Pelvic Organ Prolapse?

Normally, pelvic muscles and ligaments hold the bladder, uterus, small bowel, rectum, and other organs in place. When the support structures weaken – this can occur as a result of childbirth or trauma – one or more organs may “drop” from the lower abdomen into the vaginal opening.

The condition is usually accompanied by a number of symptoms, such as back pain, stress incontinence, constipation, and pain during intercourse. However, it is treatable. In addition to implantation of surgical mesh, a woman may choose pelvic reconstruction via abdominal surgery, laparoscopic surgery, and even nonsurgical options (e.g. implantation of a pessary).

Who Makes The Surgical Mesh?

There are several companies that manufacture the vaginal mesh (sometimes called a bladder sling). Among them are American Medical Systems (AMS), C.R. Bard, Boston Scientific, and Ethicon, which is a subsidiary of Johnson & Johnson.

What Are Common Bladder Sling Complications?

According to the FDA, the most common complications from transvaginal placement of surgical mesh include erosion through the vaginal wall, bleeding, recurring vaginal infections, and pain during sex. Vaginal drainage, lower back pain, and constipation have also been reported.

During surgery to install the device, there is a risk of bladder and bowel perforation. Even experienced surgeons may inadvertently cause such injuries due to the limited working space.

Can Transvaginal Mesh Complications Be Treated?

Treatment can resolve most complications. Doctors may recommend medications, IV therapy, and surgery, depending on the circumstances. In some cases, multiple surgeries are required to correct problems stemming from vaginal placement of surgical mesh. Other times, correcting complications may not be possible; this can occur with mesh erosion through the vaginal wall. Many women have been forced to endure chronic pain and other side effects when such problems could not be resolved.

Has There Been A Bladder Sling Recall?

To date, there has been no pelvic mesh recall issued by the FDA or any of the companies currently manufacturing bladder sling products. However, the FDA has stated they are taking steps to improve the safety of the devices. These steps include monitoring reports of complications, making recommendations to improve the effectiveness of mesh products, and evaluating relevant data regarding both.

How Did The Pelvic Mesh Gain FDA Approval?

Most of the surgical mesh devices were approved through the FDA’s abbreviated 510(k) approval process. Rather than requiring manufacturers to subject their medical devices to clinical tests, the agency merely requires them to prove their devices are similar to those already on the market. That is, manufacturers must show “substantial equivalence” between their new mesh products and previously-approved products.

The 510(k) approval process is currently under intense scrutiny. Critics point to flawed medical devices, such as the vaginal mesh, as an example of the process’s failure to ensure the public’s safety. However, this does not alleviate the responsibility of the products’ manufacturers to inform the public about potential side effects.

Have Bladder Sling Lawsuits Been Filed?

Hundreds of pelvic mesh lawsuits have been filed by women suffering serious complications caused by the devices. Most of these lawsuits have been filed against C.R. Bard and Ethicon, alleging that the companies misrepresented the safety of their products. As more information about the side effects caused by vaginal placement of surgical mesh becomes available, the number of lawsuits is expected to grow.

If you received a pelvic mesh implant and have experience bleeding, vaginal infections, and pain during sex, you may be eligible for compensation for your injuries. Contact a bladder sling lawsuits lawyer to discuss your options.

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