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When the Clot Hits the Fan

Yet another wonder drug by big drug companies is about to be brought to its knees for allegations of misrepresentation and failure to warn. This time, oral anticoagulant Xarelto of the direct Factor Xa (10-a) inhibitor class is taking center stage.

A woman in Kentucky named Virginia Stuntebeck filed a lawsuit suit against Xarelto US distributor Johnson & Johnson and manufacturer Bayer AG in federal court on February 18, 2014. In June, the federal judge remanded the case to Philadelphia Court of Common Pleas.

Xarelto (rivaroxaban) was approved in July 2011 by the Food and Drug Administration for the prevention of blood clotting in patients with atrial fibrillation (irregular heartbeat), a condition in which the blood can pool in the heart and form clots which may cause pulmonary embolism or stroke. A further approval for treatment of deep vein thrombosis (DVT) was granted in November 2011. However, the FDA has refused multiple times to approve its use as a treatment for acute coronary syndrome, perhaps in response to the growing number of complaints being reported.

The main allegation in the Stuntebeck case was that the drug was too dangerous to be sold. It was filed directly after the Pennsylvania Supreme Court ruled that drug companies can be held liable for marketing pharmaceuticals that were inherently too risky to use. Stuntebeck was prescribed with Xarelto in June 2012 to manage her atrial fibrillation, and had to be rushed to the hospital for uncontrollable gastrointestinal bleeding in February 2013.

According to the website of lawyers Williams Kherkher, 72 Xarelto-related deaths have been reported by Bayer for the first half of 2013 alone, compared to the 58 reported for 2012. If you suspect that serious injuries you have sustained may have been due to Xarelto, do not hesitate to contact a defective drugs lawyer in your area to find out if you are eligible for compensation.

A Harmful Way of Treating POP and SUI

Failure of a female’s pelvic muscles to support her bladder and urethra usually results to stress urinary incontinence (SUI) and then to unrestrained outflow of bowel or urine. (The bladder is a sac where urine is stored, while the urethra is the tube where the urine flows and released out of the body.

Stress urinary incontinence (SUI) is usually treated by having tissues sewn to provide support to the collapsed organ; these tissues are taken from the patients themselves. This procedure, though, usually requires another surgery, called hysterectomy which, in the past, has shown a high rate of failure.

The introduction of the Transvaginal/Vaginal Mesh in 1996, after the US Food and Drug Administration approved it for treating SUI cases, may have been a timely solution to doctor’s and patients’ need at the time. It was, then, manufactured by Boston Scientific and named ProteGen vaginal cling. This medical device is intended to provide added support to damaged or weakened tissue and most of those available for use are either manufactured from animal tissue or synthetic material.

The synthetic material used to produce the mesh can either be made from knitted or non-knitted sheet forms ; it may also be absorbable or non-absorbable (sometimes, both absorbable and non-absorbable materials are combined to produce one type of mesh).

In October of 2008 and then again in July of 2011, warnings were released by the FDA concerning the product’s safety. In a span of only three years, from January 1, 2008 to Dec. 31, 2010, as many as 2,874 complication cases involving vaginal mesh implants were reported to the FDA. 1,503 of these reports were about pelvic organ prolapsed complications; the remaining 1371 was about stress urinary incontinence treatment or repair.

Vaginal mesh implants are introduced as low-risk surgeries. Manufacturers of the mesh products, though, will not be able to deny the clear evidences of complications that have resulted due to the use of the product. A few of these complications are organ bleeding and perforation, vaginal scarring and shrinkage, infections, and mesh erosion. Because of these factors, many injured women have filed vaginal mesh lawsuits in order to seek compensation for the complications associated with their failed mesh implants.

If you have suffered because of a vaginal mesh implant, make sure to contact a personal injury lawyer today. An attorney will be able to help you through your case, guiding you through this difficult time.