Five years ago, Mercy Hospital in Springfield, Missouri began a Unique Device Identifier (UDI) pilot project — a program to track implanted medical devices. The project has financial backing from the U.S. Food and Drug Administration (FDA). With a new grant from the FDA, Mercy Hospital reportedly is set to receive up to $5.2 million in the next three years. The additional funding will allow...
Coloplast, the Danish medical device manufacturer, has set aside $445 million to pay U.S. women injured by the company’s transvaginal surgical mesh products. After making the announcement, Coloplast’s financial results for the year reportedly fell 62 percent.
Danish Transvaginal Mesh Manufacturer Predicts that Some Lawsuits Against it are Likely to Go to TrialVaginal mesh is a...
The U.S. Food and Drug Administration (FDA) has issued a partial response to an inquiry from a Pennsylvania congressman concerning hazards surrounding the use of power morcellators in gynecological surgeries. A power morcellator uses small rotating blades to cut up fibroid tumors, allowing the growths to be removed laparoscopically through small incisions in the abdomen. Unfortunately, many...
C.R. Bard reportedly has paid $3.6 million to a woman injured by the company’s dangerous transvaginal mesh product. The vaginal mesh lawsuit was the first case to be tried against the medical device maker.
The jury in the case awarded the injured plaintiff $5.5 million, but the court reduced the verdict to $3.6 million. After losing its appeal from the $3.6 million verdict, the...
Power morcellator lawsuits filed in federal court against Johnson & Johnson’s Ethicon unit have been consolidated for pretrial proceedings. The United States Judicial Panel on Multidistrict Litigation transferred the Ethicon lawsuits to the federal district court for the District of Kansas. That court, said the panel, is centrally located in the middle of the country and the judge has...
A decade-long study of almost 60,000 Canadian womenreportedly has revealed that an alarming 1 in 30 women treated with transvaginal mesh (TVM) will suffer pain, bleeding or other complications so severe that a second surgery is required. The troubling findings on this medical device have been published in JAMA Surgery.
Canadian Study Reveals that 1 in 30 Vaginal Mesh Patients Need Second...The United States Government Accountability Office (GAO) reportedly has decided to conduct a probe into the power morcellator surgical device. Medical device makers have been marketing and selling the dangerous devices to hospitals and gynecologists for twenty years. Recently, the Food and Drug Administration (FDA) warned that the morcellator device can spread undetected uterine...
Around the globe, patients receiving metal-on-metal hip implants have suffered serious injuries, requiring removal of the defective medical devices. In New Zealand, hospitals reportedly are allowing representatives of the metal hip manufacturers into the operating room without patients’ consent during revision surgery.
The issue came to light during a New Zealand investigation by the...
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