As a patient, being a health advocate is important. As our world progresses so does technology and the advancement in the medical field. Companies are making products so quickly, so the product can be sold in stores. Often products have not been tested to ensure the product works correctly. This…
Intuitive Surgical Inc., maker of the Da Vinci Surgical Robot broke procedures when it warned patients and surgeons about problems with the robot without first alerting regulators. The FDA noted four observations in a Form 483 letter following inspections at Intuitive’s facility. The Form 483 is a notice that informs…
Transvaginal mesh was introduced in the 1990’s to help fix pelvic organ prolapse (POP) and stress urinary incontinence (SUI). Pelvic organ prolapse occurs when a woman’s pelvic muscles weaken and the pelvic organs drop into the vagina. These organs include the bladder, rectum and uterus. Stress urinary incontinence occurs from…
In June 2012, Stryker, a medical technology company, decided to voluntarily recall its Rejuvenate and ABG II modular-neck hip stems. The modular neck-hip stems provide surgeons with the ability to correct certain aspects of a patient’s anatomy and his or her bio-mechanics. However they decided to recall these modular-neck hip…
The da Vinci Surgical Robot is a large machine with arms that surgeons use to perform surgeries. A surgeon sits in a console, which gives a 3D view of the surgery while controlling the arms. The surgeries include hysterectomies, prostate removals, gastric bypasses, gall bladder removals and thyroid cancer surgeries.…
Over the past few years the Medtronic INFUSE Bone Graft has raised many issues and resulted in large amounts of lawsuits. The Medtronic INFUSE Bone Graft is a device that is implanted after lower back surgery to stimulate bone growth in an area of implantation. The INFUSE Bone Graft is…
The medical device manufacturer Intuitive Surgical, Inc. continues to run into legal trouble over their Da Vinci Surgical Robot. An increasing number of injuries connected to this device and questions over Intuitive’s training and credentialing processes have made this product the source of numerous lawsuits. Intuitive’s surgical robot was cleared…
DePuy and Stryker are far from the only medical device manufacturers under fire for producing and promoting defective metal-on-metal hip replacement products. Biomet’s M2A-Magnum hip replacement is now the target of increasing litigation claiming the same disastrous consequences that have occurred under DePuy and Stryker systems. According to the Jere…
According to the New York Times, a jury in New Jersey has recently awarded a plaintiff over 3 million dollars in compensation for her pain and suffering after being implanted with Johnson & Johnson’s Gynecare Prolift transvaginal mesh device. Shortly after surgery, the plaintiff became plagued with constant pain, trouble…
The FDA has recently issued an urgent recall on DePuy Orthopaedics’ LPS Diaphyseal Sleeve product. The Class I recall used in this case is the most serious recall status; it denotes that there is a realistic risk of serious adverse health effects or even death. DePuy is still in the…