California Defective Medical Device Attorneys

Defective and poorly designed medical devices can be dangerous, and they injure many Americans every year. Many medical devices are created or produced in order to help improve someone’s quality of life after an illness or injury. However, if that device is not designed or manufactured properly, or is not adequately tested, additional health problems and serious injuries can result. Some typical defective medical device cases include cases involving hip replacements and implants, knee replacements and implants, bladder slings, and transvaginal mesh. If you have been injured by a defective medical device, the attorneys at Robins Cloud LLP have extensive experience in these types of personal injury cases, and they are here to fight for your rights and to help you achieve any compensation you may be entitled to for your injuries.

Defective Medical Devices and Products in California

Medical devices are meant to help people but unfortunately, many of them do not undergo adequate testing, or even testing at all before they reach the market and consumers. When this happens, injuries are more likely to occur. Anyone who has been the victim of a defective or malfunctioning medical device may find that their lives are forever changed for the worse as a result of their injuries. While the U.S. Food and Drug Administration has a process for making sure medical devices are tested extensively, ultimately, it is the device manufacturer who is responsible for making sure that the device is safe and effective. When a device manufacturer fails to inform the Food and Drug Administration about any problems the device may have, the manufacturer is considered negligent.

The manufacturer may then be liable for any injuries, illnesses, or deaths that the device may cause. A personal injury case can arise if any of the following medical devices are defective:

• Knee and Hip Replacements
  
  The Food and Drug Administration has a special approval process for knee and hip replacements. The FDA’s program clears a device and allows it to go to market if it is established that the device is substantially similar or equivalent to a device that is already being used by consumers. Because of this program, many patients are receiving medical devices that have not yet undergone adequate testing. Certain types of knee and hip replacements, like those hip replacements that use metal-on-metal devices, or knee devices that never adhere properly to the bone, have high rates of failure. These defects, whether they are due to inadequate testing, or the devices are just defective to begin with, can cause joints to slip out of place and bones to fracture. Broken bones or joint swelling may lead to immobility, and when this occurs, oftentimes additional surgery is needed to correct the problem. As with using any medical device or product, there are risks and those who may be preparing to have or have had a knee or hip replacement should be aware of the risks involved.
  
  

• Transvaginal Mesh
  
  Transvaginal Mesh is a medical device that is used to treat pelvic organ prolapse or urinary incontinence. Typically, synthetic plastics are used to create the net-like device. For those suffering from pelvic organ prolapse, the device is inserted transvaginally in order to support the bowels, bladder, and uterus and to keep them from descending into the vagina. When treating urinary incontinence, the mesh is used to support the urethra so that urine does not leak involuntarily. However, between 2005 and 2010, approximately 4,000 patients reported adverse effects from using the product.
  
  After receiving these reports, the Food and Drug Administration issued a Public Health Notification that alerted consumers to serious complications associated with the device, but also stated that adverse effects were not that common. But in 2011, the FDA amended the alert to state that one in ten patients who underwent the surgery in 2010, experienced adverse side effects. These side effects included severe pain, infections, and organ perforation. More than thirty transvaginal mesh manufacturers have been required to complete a safety review of these devices, and more than 73,000 lawsuits have been filed.
  
  
• Birth Control
  
  Medical device defects also include birth control. Some women use intrauterine devices, or IUDs, in order to prevent unwanted pregnancies. However, some of these devices have been known to perforate the organs of some women, and other have inexplicably been expelled from a woman’s body. More than 45,000 women have reported problems with IUDs, yet they continue to be offered. In addition, NuvaRing, which is also a form of birth control, has been known to cause life-threatening blood clots in some of its users. As with any device that may be placed or surgically implanted in your body, you should know the risks that may be associated with their use.