Category: Medical Devices
Major Hospital Chain Bans Morcellators in Fibroid Surgery
The Wall Street Journal reports that a major hospital chain will ban the use of morcellators in fibroid surgery due to the risk of spreading cancer.
First Zimmer Durom Hip Implant Trial Ends in Defense Verdict
December 4, 2014 -- Law360 reports that a trial involving the Zimmer Durom hip replacement has ended in a unanimous defense verdict. The so-called “bellwether” trial was the first out of more than 350 similar cases pending against Zimmer Holdings,...
FDA Adds “Black Box” Warning on Power Morcellators
The FDA has issued a Safety Communication to warn about the cancer-spreading risks associated with power morcellators.
Bayer Faces 2,500 Mirena Lawsuits in State, Federal Court
November 19, 2014 -- Bayer HealthCare is facing nearly 2,500 lawsuits involving Mirena, an intrauterine device (IUD) that woman claim can spontaneously perforate the uterus, migrate, and require surgery to remove. About half of the lawsuits have been centralized in...
Gel-E-Donut and Squishon 2 Recall Expanded for Mold Risk
November 17, 2014 -- The FDA has announced an expanded recall for the Gel-E-Donut and Squishon 2 infant gel pillows due to potential mold contamination. The products were previously recalled in May 2014, but apparently manufacturing issues were not resolved....
Covidien Puritan Bennett 980 Ventilator Recalled
November 13, 2014 -- The FDA has issued a Class I recall for a ventilator with defective software that can cause them to stop working. Healthcare providers must connect the patient to another ventilator or to a different form of...
Texas ConforMIS Knee Class Action Lawyer
ConforMIS, Inc., is facing a lawsuit alleging that the iTotal G2 knee implant is defective because components can loosen and fail prematurely. This lawsuit cites 30 complaints about the problem between 2011-2014. Overview A lawsuit involving the ConforMIS iTotal G2...
Texas ConforMIS Knee Implant Recall Lawyer
ConforMIS, Inc., has issued recalls for the iUni and iTotal knee replacements over safety concerns. Recently, they were hit with a lawsuit from a woman who claims the iTotal G2 knee implant is defective because components can loosen or detach...
Texas ConforMIS Knee Replacement Lawyer
What is the ConforMIS iTotal G2? ConforMIS Inc., a Massachusetts-based medical device company, manufactures the iTotal G2 custom knee replacement. It was approved by the FDA in January 2011. The iTotal system incorporates 3D technology to generate a custom-fit...
Texas Mirena Brain Injury Lawyer
Women who were diagnosed with a rare brain disease after taking Mirena have filed lawsuits against Bayer downplaying the risk of brain injuries, such as Psuedotumor Cerebri (PTC) and Intracrainal Hypertension. Several studies link the hormones in Mirena with elevated...