Hips, knees, heart, bladder, abdominal wall . . . these are just some of the body parts that can be assisted through the implantation of “medical devices.” Whether they replace the original body part or just improve its function, medical devices help thousands of people each year. Unfortunately, patients can also be injured when the design, manufacture or application of the device is defective.
Surgical Complications? It Could be a Defective Medical Device
Our Columbia product liability lawyer at the Louthian Law Firm have been assisting injured patients in South Carolina for over four decades, including those who were harmed by defective or recalled medical devices. When life goes wrong, we fight for what is right and for fair compensation for those injured by negligence in the healthcare industry. Call us at 803-592-6231 to schedule a free and confidential consultation.
Definition of “Medical Device”
Many products used to diagnose and treat patients are considered to be medical devices, and they range from simple bandages and gloves to complex units such as pacemakers and defibrillators. Most medical devices fall into a middle category, including hip and knee replacements, surgical mesh, X-ray machines, medical lasers, infusion pumps, and ultrasound equipment. Drugs and blood products are not categorized as medical devices.
Medical Device Failures
Unfortunately, medical devices don’t always function as they were intended to, because of a defect in their design or manufacture. Complex devices sometimes fail because of a software malfunction. Defective medical devices can necessitate further surgeries, cause disability, and even result in the patient’s untimely death.
The Regulation And Recall of Medical Devices
The Center for Devices and Radiological Health, a division of the U.S. Food and Drug Administration, regulates the manufacture, packaging, labeling, and importation of medical devices sold in the United States. The FDA can recall a dangerous or defective product and either require corrective action or mandate its removal from the marketplace. In 2012, the FDA recalled 1,190 medical devices and radiation-emitting products. Listed below are some of the medical devices which in recent years have been found to be dangerous, resulting in recall or voluntary withdrawal by the manufacturer:
Metal-on-metal hip implants often cause severe inflammation and have a high rate of infection; many patients have had to have MOMs replaced or removed within five years. These devices have also been associated with the release of metal particles into the body (metallosis), which damages the heart, kidneys, nervous system and thyroid. Some of the metal-on-metal hip implants recalled or investigated are the Smith & Nephew R3 Metal Liners of the R3 Acetabular System, Zimmer Durom Acetabular Component, Stryker Rejuvenate and ABG II hip systems, Biomet M2a, Wright Medical Technology Conserve Plus and Sulzer Inter Op Shell.
Knee replacements may prematurely fail or loosen, leading to injuries, pain, infection, inflammation, bone or muscle damage and necessitating painful revision surgery. Withdrawn or recalled products include the Zimmer NexGen LPS, CR and MIS, Zimmer Natural Knee System, Stryker Scorpio CR and PS components, Stryker Duracon Total Knee, Stryker Unicompartmental Knee System, Smith & Nephew Oxinium Genesis II and Profix II, Smith & Nephew Journey Uni Tibial Baseplate and Biomet Vanguard CR.
Pain pumps may be implanted when oral pain medications cannot control a patient’s pain. But some patients have died because the medication injected directly into their tissue instead of into the pump or when an electrical short occurred in the product. Some of the problematic pain pumps are the Medtronic SynchroMed II, I-Flow ON-Q Pump, Stryker PainPump Two Site Infusion Kit and Sorenson Medical pumps.
Surgical mesh products are often used to repair hernias, stress urinary incontinence and pelvic organ prolapse. But some have been found to cause pain, infection, scarring and damage to nearby organs, including the Boston Scientific ProtoGen transvaginal mesh, Mentor Corp. ObTape Vaginal Sling, Johnson & Johnson Gynecare Prolift, TVT Secur and Prosima pelvic mesh, C.R. Bard Avaulta Plus pelvic mesh, C.R. Bard Composix Kugel hernia patch, Ethicon Proceed hernia mesh and LifeCell AlloDerm hernia mesh.
Legal Remedies For Defective Medical Device Injuries
Medical device manufacturers are required by law to make products which are safe and which will provide the intended benefit. When they fail to safely design or manufacture the product or properly package or label it, they may held accountable in a court of law.
We will investigate every aspect of the product’s development and application to make sure all appropriate defendants are named in the lawsuit. This could include the laboratory which failed to conduct adequate pre-market testing; the manufacturer who failed to maintain quality control; the doctor or hospital which failed to warn of possible complications or give adequate instructions; as well as others whose negligence contributed to your injury.