Medical Devices

An Overview on Devices, Safety and Recalls

Defective Medical DevicesInnovative technology has improved many medical devices to assist patients suffering from a variety of conditions. Many individuals facing life-threatening or chronic medical issues undergo extensive surgery and have medical devices implanted, or use the device externally before, during and after a medical procedure. As a result, improvements in medical advancements are delivering much-improved patient outcomes.

Medical devices include any apparatus, implant, machine or instrument intended to improve, prevent, assist or treat a medical condition or disease. Literally thousands of medical devices are used in the health care industry, including:

  • Knee and hip implants
  • Breast implants
  • Heart defibrillator
  • Catheters
  • Contact lenses
  • Mesh hernia patches
  • Intrauterine device (IUD)
  • Heart valve implants
  • Kidney dialysis filters
  • Insulin pumps
  • Heart stents
  • Dental implants
  • Transvaginal mesh (TDM)
  • Spinal fusion bone grafts
  • Pain pump and syringes
  • Pacemakers

Unfortunately, medical devices are not without inherent risks, even though all medical device manufacturers are required by law to adhere to strict regulations enforced by the FDA (Food and Drug Administration) Center for Devices and Radiological Health.

This organization sets medical device standards and regulates all medical devices and equipment. Any failure of a device to adhere to the standards allows the FDA to request a voluntary recall by the manufacturer. If the manufacturer refuses to comply with the FDA request, the agency can issue the recall.

In addition to the FDA, the CPSC (Consumer Product Safety Commission) maintains accurate records on accidents and mishaps with medical devices. On average, there are more than 450,000 injuries caused by medical devices every year in the US.

Defective Medical Devices

Many times, when a medical device is defective it can cause damage or injury to the patient that may take hours, days, months or years to realize. Sometimes, the defective medical device actually causes death due to poor construction, development or design. Other times, the attending physician might cause a medical error during a procedure when using or implanting the device, or through an infection that develops due to using the device.

A Rush to Market

Medical device manufacturers spend billions in the research and development phase on a single product in an effort to compete in a crowded medical marketplace. These companies often face intense pressure from their shareholders to recoup the extensive costs.

Often times there are unfortunate compromises during the assessment and evaluation processes. These large companies will neglect safety and health issues to rush the product to market to start generating profits. Sadly, faulty designs of medical devices often lead to serious injuries or death for the unsuspecting patient who was taking strides to improve their health. Many times, the defect of the medical device is not found until the unit is made available to the general public.

Common Side Effects

In addition to dying from a failure of a medical device, patients also experience a variety of other common side effects that can lead to serious injury or eventual death. Some of the most common side effects acquired through a defective medical device include:

  • Deep vein thrombosis (DVT)
  • Blood clots
  • Inflammatory response
  • Tissue erosion
  • Sudden cardiac death
  • Stroke
  • Infection
  • Cartilage destruction

Aside from the serious side effects, many patients suffer extensive pain and discomfort. Manufacturers of medical equipment are completely responsible for the safety and reliability of the products they bring to market. When the manufacturer fails to develop, manufacture and maintain those basic standards, and the device causes serious injuries or death, they can be held legally responsible by the consumer.

Medical lawsuits are more than just about poor standard of care, misdiagnosis and malpractice. In fact, too often the medical device fails or produces serious side effects that cause significant injuries, sickness or death. When this occurs, it is essential to hire a personal injury attorney who handles personal liability cases, and specializes in defective medical devices. The attorney will skillfully investigate the medical procedure, the device’s history and the extent of the patient’s outcome to evaluate the potential of financial compensation.

Current Recalled Medical Devices

With the literally thousands of medical products on the market, many have been recalled for defects. Some recalled devices include:

  • J & J Hard Stents
  • Zimmer and Stryker Hip Implants
  • Medtronic and Guidant Heart Defibrillators
  • Bard Composix Kugel Hernia Mesh
  • Wright Pro Femur Implant
  • NuvaRing Contraceptive Device
  • Transvaginal Mesh Bladder Slings
  • Zimmer, Stryker and Depuy Knee Implants
  • Post-Operative Pain Pumps
  • Medtronic Infuse Spinal Fusion Bone Graph

Find Out More at: http://www.FDA.gov/MedicalDevices/safety/default.htm