Monday, July 22, 2013

Vaginal Mesh MDL Status Conference Held in West Virginia

A status conference was recently held in the U.S. District Court for the Southern District of West Virginia, according to online news sources. This status conference reportedly discussed the growing number of transvaginal mesh lawsuits currently pending in various courts across the country. Apparently, reports say the number of claims rose by a large margin, particularly in recent years. Most of the lawsuits claim that the manufacturing company negligently exposed women to defective medical products.

Transvaginal mesh devices, also known as vaginal mesh devices, are implants used in vaginal repair surgeries. They are often used for treating pelvic organ prolapse (POP), which is the collapse of pelvic organs into the vaginal wall, and stress urinary incontinence (SUI), which is the involuntary leakage of urine, according to medical experts. The occurrence rate of both medical conditions reportedly rose in the late 1990s, triggering numerous medical manufacturing firms to develop their own versions of the transvaginal mesh implant. Such companies include C.R. Bard, Ethicon, Inc., Tyco Healthcare, and American Medical Systems. Shortly after the devices were released to the market, however, many patients implanted with the devices complained of pelvic pain and various other complications.

Reports of injuries associated with transvaginal mesh devices are not new, nor are they rare in the United States. In fact, the U.S. Food and Drug Administration (FDA) stated in 2008 that it had received more than a thousand complaints of transvaginal mesh implant injuries within a three-year period. Moreover, the agency issued another transvaginal mesh alert in 2011, stating that it had received about 2,900 more adverse event reports, with injuries allegedly linked to surgical mesh implants.

Based on the reports submitted to the FDA, patients have suffered from various serious complications. Such complications include mesh erosion, perforation, recurrent POP, and painful intercourse. In some reports, patients were required to undergo additional procedures in order to take out the failed implants. Consequently, many of the injured are now pressing charges against the companies responsible for the production and distribution of the alleged devices. Further information and updates regarding these lawsuits involving transvaginal mesh devices and the vaginal mesh status conference may be found on personal injury law firm websites, such as the Rottenstein Law Group’s rotlaw.com.

Cook Medical May Soon Join Litigation in West Virginia

Another transvaginal mesh company known as Cook Medical, Inc. may soon be named as one of the defendants in the West Virginia litigation, according to online news reports. As of now, the Judicial Panel on Multidistrict Litigation is reportedly still deciding on whether or not the transvaginal mesh lawsuits against the said company should be merged. However, legal experts believe that the growth in the number of such cases indicates a forthcoming consolidation. Meanwhile, the West Virginia court is currently supervising pre-trial proceedings in claims that involve transvaginal mesh products manufactured by Boston Scientific, American Medical Systems, C.R. Bard, Ethicon, and Coloplast.

Cook Medical Inc. is a medical firm that was established in the year 1963, online sources say. It focuses mainly on health research and manufacturing equipment and products for general surgery, bioengineered tissue regeneration and replacement, endoscopy and gastroenterology procedures, urology, endovascular therapy, gynecology, and obstetrics.

During the 1990s, at which time transvaginal mesh devices were on demand, Cook Medical reportedly developed mesh products of its own named Surgisis Biodesign mesh and Stratasis mesh products. These devices were fashioned for women suffering from pelvic organ prolapse (POP) and stress urinary incontinence (SUI). They provide support for the pelvic organs, keeping them in their original position and reducing symptoms. Due to the popularity of mesh devices, Cook Medical’s products were initially well received by the public.

However, reports further revealed that just like several other mesh products, the Surgisis Biodesign mesh and Stratasis mesh devices have been linked to complications. Such complications include mesh erosion, recurrent POP, infection, urinary problems, device embedment, and organ perforation. Some of the patients suffering from the above complications reportedly underwent additional surgeries in order to alleviate their conditions. Others have also reported of permanent injuries as a result of organ damage.

When Cook Medical originally released the Surgisis Biodesign bladder sling to the market, the company reportedly advertised it as superior to other mesh devices due to the fact that it was made out of the small intestines of animals rather than from synthetic materials. However, post-market research studies uncovered that mesh devices made from animal intestines may, in fact, increase the likelihood of inflammatory adverse effects.

In the year 2011, the U.S. Food and Drug Administration cautioned the public about the severe nature of transvaginal mesh complications, stating that complications are more common than previously anticipated. More information regarding this subject and lawsuits involving transvaginal mesh implants may be found on personal injury law firm websites, including the New York-based Rottenstein Law Group’s www.rotlaw.com.


Friday, July 12, 2013

GranuFlo Complications Lead to 11 Patient Deaths

A total of 11 dialysis patients have died after undergoing dialysis treatment using Granuflo and Naturalyte, according to the latest news on Fresenius’ problematic dialysis products. Unsurprisingly, the loved ones of these alleged victims have filed a Granuflo lawsuit against Fresenius Medical Care, demanding compensation for all the damages they have suffered. These lawsuits were filed in various courts across the country, including Georgia, Ohio, Kentucky, Virginia, Texas, Illinois, California, and Florida. Based on released court documents, the deaths occurred between 2010 and 2012.

Granuflo and Naturalyte are dry acid concentrates used in dialysis treatment. Both of these dialysates are produced by Fresenius Medical Care, the largest operator of dialysis facilities in the United States. They were first introduced to the market in the year 2003, after which they became very popular. Despite their popularity, however, many dialysis patients reportedly developed severe complications. As a course of action, the manufacturing company conducted research studies to determine the safety of its dialysis products.

Findings from these studies reportedly linked the use of Naturalyte and Granuflo to an increased risk of heart attacks and strokes. Apparently, many of the patients involved in the study developed heart-related complications after being administered with the dialysis products. In fact, some patients have reportedly died due to the severity of their conditions.   

When Fresenius found out about the dangers of Granuflo and Naturalyte, the company immediately sent a warning memo to its own dialysis centers. However, it had failed to warn other facilities that use the products in a timely manner. Even so, a copy of the said memo was anonymously sent to the U.S. Food and Drug Administration (FDA) a year later, which prompted the agency to issue a class I recall of Naturalyte and Granuflo.

After the recall of Granuflo and Naturalyte, many injured patients pressed charges against the manufacturing company, Fresenius Medical Care. Based on these filed lawsuits, the dialysis products may potentially cause fatal injuries, such as heart attacks, strokes, and other heart-related adverse effects. More information pertaining to safety concerns and lawsuits involving Granuflo and Naturalyte may be found in articles published on personal injury law firm websites, including the Rottenstein Law Group’s rotlaw.com.