Manufacturers of Vaginal Mesh Hit With Lawsuits

Problems with vaginal mesh systems marketed by a number of different medical device manufacturers have caused thousands of women throughout the United States to suffer severe injuries and file vaginal mesh lawsuits. Also known as a pelvic sling or bladder mesh, transvaginal support systems have been associated with a number of serious and debilitating internal injuries for women. Not only do these products pose a risk of serious vaginal mesh complications, there is no evidence that transvaginal insertion of a bladder sling has any benefit for women when its primary use is treating pelvic organ prolapse.

In many surgeries the transvaginal mesh used has failed in one of several ways, often eroding through the vaginal wall or skin. This causes incredible amounts of pain and alters women’s lives who suffer from a malfunctioned transvaginal mesh. Previous accounts of transvaginal mesh defects have women describing their pain, unable to sit, stand or lay in position for more than a few minutes at a time. Categorized by the FDA as medical devices that the FDA can clear for sale based on their similarity to medical devices already on the market and without the benefit of human testing, the implants have so far spawned more than 650 lawsuits filed by patients alleging that they have been significantly injured as a result of having mesh products implanted transvaginally. The use of vaginal mesh for pelvic organ prolapse and female stress urinary incontinence has been linked to painful and potentially disfiguring problems.

The judge presiding over all federal Bard Avaulta vaginal mesh lawsuits has asked the parties to develop a list of potential bellwether cases, which would be prepared for early trial dates in the multidistrict litigation (MDL). More than 250 lawsuits over C.R. Bard vaginal mesh filed in federal courts throughout the United States have been consolidated before Judge Goodwin for pretrial litigation as part of an MDL. While the litigation initially only included Bard Avaulta mesh products, it has since been expanded to include at least 29 other types of vaginal mesh made by C.R. Bard or their subsidiaries, including Pelvicol, PelviLace, PelviSoft, Pelvitex, Uretex and Align mesh.

Minnesota Woman Files Vaginal Mesh Lawsuit

Myndal Johnson joined dozens of women who have filed vaginal mesh lawsuits on January 9, 2012, prompted by information released by the Food and Drug Administration regarding vaginal mesh complications. The FDA recently concluded that the continued use of vaginal mesh was a concern because of the potential for side effects and vaginal mesh complications associated with use of the devices. Johnson received a vaginal mesh implant in June of 2001 in order to treat stress urinary incontinence, and began experiencing vaginal mesh side effects shortly thereafter. 

According to the lawsuit filed by Johnson's vaginal mesh lawyer against mesh manufacturer Ethicon, Inc. Johnson began experiencing side effects such as pain and bleeding after intercourse shortly after her initial vaginal mesh surgery. She also began to suffer from vaginal mesh erosion, hardening, and chronic pain. Eventually, in January of 2008, Johnson underwent a second surgery to remove the vaginal mesh in order to help fix the problems that it had caused. Johnson is now suing Ethicon with the help of her vaginal mesh lawyer due to "severe mental and physical pain."

Vaginal Mesh Complications Might Impact Device Sales, Studies Say

Vaginal mesh is a device that has looked promising in some patients in the treatment of conditions such as stress urinary incontinence and pelvic organ prolapse, but it has been giving a number of patients a lot of trouble. Significant side effects have come to light as more and more doctors are thinking twice before deciding to use the mesh on patients. According to a study conducted by Millennium Research Group, sales of vaginal mesh have declined recently and are expected to do so more in the future because of vaginal mesh complications. Some patients are even looking into taking legal action after experiencing vaginal mesh complications.

Mesh devices were released into the United States medical market in 1996, approved to treat stress urinary incontinence. The Food and Drug Administration approved the devices to treat pelvic organ prolapse in 2002, increasing the target market of the vaginal mesh devices. Ongoing pain, urinary incontinence, and painful intercourse are among the side effects patients are now worried about as more and more information about vaginal mesh complications comes to light. 

Current Data on Vaginal Mesh Implants Does not Satisfy the FDA

What was once a fast-growing sector of medical surgery, vaginal mesh implants to treat pelvic organ prolapse (POP) saw flat sales throughout 2011. The FDA has been studying transvaginal mesh complications for several years now. This past July, the agency said in a safety communication that it had received 2,874 new reports of complications associated with transvaginal surgical mesh procedures from January 2008 through December 2010. Of these, 1,503 reports were associated with POP repairs, representing a fivefold increase in adverse event reports related to such procedures. During the same period, the FDA received 1,371 reports of complications relating to SUI repairs. It is expected that the number of transvaginal mesh lawsuits will only rise.

Last summer the FDA issued a warning about the risks of problems when vaginal mesh products are used, especially for repair of pelvic organ prolapse. The federal health regulatory agency indicated that it could find no benefit in using transvaginal mesh to treat POP when compared to older, safer alternatives. Transvaginal mesh complications reported to the agency have included mesh erosion through the vagina, pain, infection, bleeding, pain during sexual intercourse, organ perforation, and urinary problems. The FDA also said in its July communication that its review had not seen any evidence that POP repair with transvaginal mesh offered additional benefits compared to other treatment methods.

A growing number of transvaginal mesh lawsuits have been filed in courts across the country by women who say that vaginal sling manufacturers created defective products and failed to warn doctors or patients adequately about the risk of complications. Manufacturers that have been targeted by vaginal mesh product liability lawsuits include Johnson & Johnson’s Ethicon unit, C.R. Bard, Boston Scientific, and American Medical Systems (AMS). The FDA has suggested that companies design the studies in such a way that they could satisfy requirements for premarket approval applications for products that would be used in transvaginal POP procedures. the FDA suggested companies design the studies in such a way that they could satisfy requirements for premarket approval applications for products that would be used in transvaginal POP procedures.

Vaginal Mesh Lawsuits in Multidistrict Litigation

A number of patients who have experienced problems with vaginal mesh have been filing lawsuits against the manufacturers of the mesh. Seven of these lawsuits, filed in Minnesota, have been consolidated into one case. This will help the litigation process become smoother and quicker for plaintiffs and defendants alike by consolidating the pretrial processes in similar cases to make the legal process move more quickly. Each of the vaginal mesh lawsuits in the consolidated case deals with vaginal mesh side effects based on the possibility of failure associated with transvaginal mesh cases. 

AMS Named Defendant in Vaginal Mesh Side Effects Lawsuit

On December 22, 2011, Martha Bowman became the latest plaintiff to file a vaginal mesh lawsuit in U.S. District Court in the Central District of California. Bowman, a Florida resident, and her vaginal mesh lawyer named American Medical Systems (AMS) as defendant in the lawsuit, which alleges vaginal mesh side effects suffered from implantation of AMS products.

Plaintiff Allegedly Suffers Vaginal Mesh Side Effects

Plaintiff Bowman suffers from vaginal vault prolapse and stress urinary incontinence (SUI), two conditions caused weak pelvis muscles that are incapable of supporting internal organs such as the bladder and uterus. On September 8, 2008, Bowman underwent surgery to correct these conditions. During surgery, Bowman received several AMS products including the Apogee System with Intepro Lite, Perigee System with Intepro Lite, and the Monarc Subfascial Hammock.

According to her vaginal mesh lawyer, Bowman allegedly began experiencing vaginal mesh complications soon after surgery. The plaintiff's vaginal mesh side effects included recurrent infection in the tissues adjacent to the mesh, as well as erosion and pelvic pain. In August 2009, less than one year after her initial surgery, Bowman was forced to undergo vaginal reconstruction surgery.

Vaginal Mesh Lawyer Charges AMS with Intentional Concealment

Bowman's vaginal mesh lawsuit alleges that AMS was aware of vaginal mesh complications and side effects associated with their products, and claims that the company favored profit over patient safety. The lawsuit states that AMS "intentionally concealed and suppressed certain results of testing and research to healthcare professionals, Plaintiff, and the public at large."

In October 2008, the Food and Drug Administration (FDA) issued a Public Health Notification, stating that the organization had received more than 1,000 complaints related to vaginal mesh side effects, including those linked to AMS devices. Vaginal mesh complications include rates of erosion and pelvic mesh failure higher than with other products used to treat SUI and prolapse. On July 13, 2011, the FDA updated its safety communication, warning consumers that vaginal mesh complications are not rare, and that vaginal mesh surgery incurs greater risk of complications than do other surgical options.

Bowman Seeks Vaginal Mesh Settlement

Through her vaginal mesh lawyer, Bowman is seeking damages for medical monitoring, pain and suffering, health care costs, lost wages, and loss of earning capacity. She is also asking the court for punitive damages.

Vaginal Mesh Complications Arise From Alleged Defects

Last summer, the FDA issued a warning about the risks of problems when vaginal mesh products are used, especially for repair of pelvic organ prolapse. The federal health regulatory agency indicated that it could find no benefit in using transvaginal mesh to treat POP when compared to older, safer alternatives. Vaginal mesh complications have occurred while the systems were marketed by a number of different medical device manufacturers have caused thousands of women throughout the United States to suffer severe injuries, leading to multiple vaginal mesh lawsuits. Arminta Bell of Minnesota has alleged that a hernia patch manufactured by C.R. Bard, Inc., resulted in a need for additional surgery, causing severe pain.
Due to the risk of vaginal mesh complications, the FDA warned in July 2011 that doctors should recognize that in most cases, pelvic organ prolapse can be treated successfully without a bladder sling or pelvic mesh. Thousands of women had a bladder sling or vaginal mesh implanted in recent years, and compensation may be available for serious injuries caused by the defective and dangerous design of the pelvic support systems. A vaginal mesh lawyer will also argue that his or her client was unaware of the risks associated with using a transvaginal mesh. In Arminta Bell’s case, she received the implant to repair a hernia, completely unaware of the complications that had been linked to the product manufactured by C.R. Bard, Inc.
The vaginal mesh products have been approved through the FDA’s controversial 510(k) fast-track approval process, which only requires that they be substantially equivalent to a device that has already been approved for sale. That means that there were no requirements for clinical studies or tests of safety or effectiveness before the medical devices were implanted in American women. An estimated 300,000 synthetic transvaginal meshes were implanted in women in the U.S. in 2010. As a result of the medical device manufacturers’ failure to adequately research the potential vaginal mesh problems or warn consumers and the medical community about the risk of complications, financial compensation may be available through a vaginal mesh lawsuit or class action claim.