At this time, the pile of lawsuits is growing against Boston Scientific and several rival manufacturers (C.R. Bard, Johnson & Johnson and American Medical Systems), and in each case, the companies’ vaginal mesh implants/inserts were used to try to help with or fix incontinence or a condition known as pelvic organ prolapse. The federal cases against Boston Scientific are being consolidated in Charleston, West Virginia.

Approximately 1,300 federal suits that cite the vaginal mesh issue have reportedly been filed against the four companies, including nearly 170 naming Boston Scientific. In Massachusetts, another 100-plus suits against Boston Scientific are in the Middlesex County Court system under the oversight of Judge Diane Kottmyer. Some plaintiffs have apparently chosen the County Court route with the hope that their case will be resolved more quickly than if it were a federal case.

In general, Boston Scientific has declined to comment on the litigation, other than to say that the company believes that transvaginal placement of mesh for incontinence and pelvic organ prolapse remains an important treatment option for patients. It says that it continues to work with the Food & Drug Administration (FDA) to ensure that appropriate information about the mesh products is provided to doctors and their patients.

As you will see in the infographic below, it succinctly and clearly illustrates how several vaginal mesh products, all of which became the subject of hundreds of lawsuits and were manufactured by different companies, attained FDA approval based on their similarity to a recalled device. It features a timeline of significant events in the history of vaginal mesh, details about the vaginal-mesh-injury reports the FDA received prior to issuing a public alert stating that “serious complications associated with surgical mesh … are not rare,” and statistics illustrating the breadth and scope of the vaginal-mesh-injury epidemic.

Click the image below to see a larger version.

According to him, the FDA now lacks that authority in many cases, creating a “loophole” that has challenged the credibility of some device approvals … see more in this BusinessWeek report.

1. Incontinence problems that persist even after implantation of the mesh
2. Feeling a sensation of “pulling” in the abdomen while walking or bending

In some instances, victims have reported that the mesh penetrated the vaginal wall, thus requiring surgery to trim, leading to severe pain, infection, scar tissue and a lack of sensation in the vagina after corrective surgery.

If you’ve been the recipient of a transvaginal mesh implant, and are experiencing any of the following secondary symptoms, the same applies:

1. Severe depression linked to problems associated with mesh implants, including lack of intimacy and pain
2. Severe anxiety due to persistent incontinence problems
3. Personal relationship issues, separation and divorce due to the physical and emotional trauma associated with mesh implants
4. Significant decline in quality of life

In all instances outlined above, for very obvious reasons, you may also want to contact a lawyer.

In support of their petition, the congressmen cited problems associated with medical devices, such as transvaginal mesh implants, which have caused serious injuries to patients. According to the congressmen, these harms demonstrate the need for regulatory reform.

In highlighting the need for regulatory reform, the congressmen examined transvaginal mesh implants. According to the congressmen, complications and adverse side effects associated with transvaginal mesh provide a clear example of why regulatory reform is warranted. As discussed in great detail in the letter, transvaginal mesh implants received market clearance from the U.S. Food and Drug Administration (“FDA”) through the expedited 510(k) process. By utilizing this process, manufacturers of these devices did not have to conduct clinical testing in order to receive approval.

Since transvaginal mesh was introduced into the market, the FDA has received thousands of adverse event reports, and issued a series of alerts to warn consumers of dangerous complications associated with vaginal mesh. In fact, the FDA is still conducting an ongoing safety review. The FDA estimates that 300,000 women were implanted with vaginal mesh in 2010. At the same time, according to a recent article in Bloomberg News, there are more than 650 transvaginal mesh lawsuits currently pending against manufacturers, including Johnson & Johnson and C.R. Bard.**

The letters ask each vaginal mesh implant manufacturer to collect data on the results and potential complications of transvaginal procedures, i.e. procedures where the hammock-like meshes are threaded in place through an incision in the vagina. According to the FDA, almost 300,000 of these synthetic meshes were implanted in U.S. women in 2010 to treat incontinence or shore up pelvic muscles. The alleged failures of some of these devices have resulted in more than 650 lawsuits against manufacturers, and caused heightened scrutiny of the FDA program that cleared the products for sale (in the first place) without human testing.

The companies in question have 30 days within which to comply with the FDA mandate.

Reports indicate that the latest lawsuits were filed in Kansas and Massachusetts federal courts. Each of the women who filed suit claims they suffered painful and permanent injuries caused by a Boston Scientific vaginal mesh product. According to court documents, the lawsuits allege that the company’s vaginal mesh products migrated and attached to surrounding tissues and did not function properly, resulting in severe pain, tissue damage, infection, swelling and other complications.

The Vaginal mesh implant product was first introduced in 1996, as a means of treating pelvic organ prolapse (POP) (a condition that can cause stress urinary incontinence in certain women). The mesh is intended to reinforce and support the pelvic floor muscles and prevent the internal organs from bulging outward.

Since 2008 however, the U.S. Food and Drug Administration (FDA) has received nearly 3,000 complaints from women who claim they were adversely affected by a vaginal mesh implant. In July 2011, the FDA issued an updated safety communication regarding these devices, advising doctors and patients of the potential for serious side effects with these products.

The study, which will be detailed in the January 2012 issue of the American Journal of Obstetrics and Gynecology, found that women who are fitted with a vaginal mesh device to treat pelvic organ prolapse typically require additional surgery more often than women who are treated using other methods. Pelvic organ prolapse (POP) is a condition that causes a weakening of the pelvic floor muscles in certain women. Depending on its severity, POP can cause the internal organs to bulge or sag outward through the vagina.

The study looked at post-treatment outcomes for 32 women who received a mesh implant and 33 women who underwent traditional prolapse repair methods. Researchers found that 15.6% of the women who received a transvaginal mesh device required additional surgery within 1 year of the initial treatment. They also concluded that women who were treated using other methods saw a comparable reduction in prolapse symptoms compared with mesh recipients.

In addition to drafting the legislation, senators have reportedly sent letters to several vaginal mesh manufacturers, including Bard and Johnson & Johnson, requesting additional information about how the devices are checked for safety and how a recall is handled if deemed necessary.

Currently, the U.S. Food and Drug Administration (FDA) allows certain medical devices to be approved under its 510(k) system. Based on these guidelines, manufacturers only have to demonstrate that their product is substantially similar to one already on the market. The Senate has cited the 2010 recall of the DePuy ASR hip implant system, which was approved under the 510(k) rule, as evidence that the guidelines are ineffective in ensuring public safety.

The new draft legislation comes in light of the fact that C.R. Bard (a maker of vaginal mesh implants) is facing hundreds of lawsuits from women who claim that its Avaulta transvaginal mesh system caused pain, bleeding, blood vessel damage, scarring and other complications. Johnson & Johnson faces a similar number of suits from women who say they were injured by the company’s Ethicon Gynecare mesh system. The first bellweather trials in the Johnson & Johnson cases are scheduled to begin in a New Jersey federal court in November 2012.