Defective Medical Devices
With greater frequency, we undergo surgery to have artificial devices implanted to restore us to full and complete health, not further injury. You have a right to expect no less from a manufacturer. Yet, inadequate testing or improper follow-up by the device manufactures often lead to further pain, suffering, and possible death.
Active Investigations and Litigation
Bair Hugger Warming Blankets
The 3M Bair Hugger surgical warmer is a medical device used in many operating rooms during hip and knee replacement procedures to keep the body warm and improve surgical outcomes. The device forces warm over a patient’s body as well under the surgical surface. The air released under this table however also spreads potentially infection over the sterile surgical site. MRSA and sepsis are two of the many potentially germs and bacteria spread by this device.
Treatment is often difficult, sometimes requiring additional surgery or long-term antibiotics.
Originally designed to catch blood clots (pulmonary embolisms) before the reach your lungs, Inferior Vena Cava filters (IVC) have been increasingly found to susceptible to fracture or migration. When this complication occurs, a person is at risk of perforation of any organ or blood vessel. Removal by surgery may be required; not all devices can be removed without further harm to the individual.
The FDA has advised that retrievable IVC filters be removed within a month or two of implantation. Hundreds of reports of IVC filters breaking within the body and damaging organs have been received by the agency.
Notably, C.R. Bard which manufactures the Recovery IVC filter and Bard G2 IVC filter, as well as the Cook Celect IVC filter, and Gunther Tulip IVC filter are currently facing hundreds of lawsuits.
Tiny surgical devices with rapidly rotating blades, power morcellators are used by surgeons to perform a hysterectomy or remove uterine fibroids. In the process, the large tissue is sliced or minced into tiny pieces and sucked out of the body through a laparoscope.
This process, however, can cause the spread of undiagnosed cancerous tissue throughout the abdomen. Until the tissue is removed from the body surgically, medicine does not have any method of distinguishing the cancerous uterine or endometrial tumors from the benign, or harmless, tumors. Such cancerous tumors are leiomyosarcoma (cancer beginning in smooth muscle cells), endometrial stromal sarcoma (cancer beginning in the connective tissue cells), endometrial adenocarcinoma (endometrial cancer), and uterine carcinosarcoma (cancer beginning in the lining of the uterus).
Johnson & Johnson Ethicon, Cook Urological Inc., and Smith & Nephew are a few of the manufacturers of these dangerous devices. Several lawsuits have been filed against these manufacturers and more are expected to be filed due to cancer development and death.
As early as 2006, Johnson & Johnson knew about the potential spread of malignant tissue. However, not until the FDA’s urged physicians to stop using morcellators for uterine fibroid removal did Johnson & Johnson suspend sales. Many hospitals have discontinued their use of these unsafe devices.
A manufacturer of orthopedic surgical devices and implants, Zimmer has voluntarily recalled more than 11,600 Zimmer Persona Trabecular Metal Tibial Plates. An urgent Medical Device Recall notice had been sent out in February 2015 warning surgeon and hospitals that these plates may “loosen”. Zimmer has also recalled the Zimmer Person Tibial Articular Provisional Shim tool. Ball bearings from this device may have been left in the actual surgical site, increasing the risk of infection and additional surgeries. Though used world-wide, Zimmer sent these devices specifically to surgeons in Alaska, Alabama, Arizona, California, Colorado, Florida, Illinois, Indiana, Kansas, Massachusetts, Michigan, Minnesota, Missouri, New Jersey, New York, North Carolina, Ohio, Oklahoma, Pennsylvania, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin.
For years, thousands women suffering from Pelvic Organ Prolapse (POP) or Stress Urininary Incontinence (SUI) were treated with transvaginal mesh and bladder slings. Unfortunately, severe complications, such as pain, infection, vaginal scarring, mesh erosion, and perforation of the bowel, bladder or blood vessels, have occurred. The treatment of these complications often require surgical repair, IV therapy, drainage of hematomas, and blood transfusions.
These mesh devices were manufactured by large drug companies such as Johnson & Johnson, American Medical Systems, Boston Scientific, Ethicon, a division of Johnson and Johnson, and C.R. Bard. Despite numerous injuries reported to the Food and Drug Administration, these devices are still sold and implanted in women today, placing them at risk of serious harm.
Recently, after tens of thousands of lawsuits by women suffering severe vaginal mesh complications, however, the FDA has reclassified transvaginal mesh products and designate them as Class III, which generally includes high-risk devices. The FDA has also strengthened the approval process requirements for surgical mesh for transvaginal repair of POP.
Today, over ten trials have proceeded to verdict against these manufacturers. In many, the jury has awarded punitive damages against one or manufacturers for the harm they caused.