Medical devices cover a variety of items that provide a medical service but are not medicine, like pacemakers or hip and knee replacement parts. The development of medical devices has allowed people to live longer, more comfortable lives. However, if a medical device is poorly designed or manufactured incorrectly, it can end up hurting a patient more than helping. Sadly, Ramsey Law Group has seen all too often the pain and suffering have a defective medical device can bring to a person and his or her family. Knowing how terrible this time can be, we work hard to make sure our clients get the compensation they deserve and to hold the device manufacturer accountable for the hardships caused. For more information about your claim, contact a Texas medical malpractice lawyer today.
While medical device manufacturers are certainly not in the business of trying to hurt patients, products can prove harmful if they are not fully tested in a rush to get the device to market or corners are cut when manufacturing the items. Additionally, the Food and Drug Administration (FDA) is charged with testing certain consumer products before they can be sold. Although they have stringent requirements and thorough testing, sometimes defective products still make it through the process. Also, the FDA has a program to fast-track certain devices similar to existing approved devices, and items approved in this manner are less likely to be fully scrutinized. After the FDA signs off on a device, it can only be recalled if a number of patients report having problems with the device.
Some common devices we have seen as having a defect include pacemakers, implants, pumps for insulin or other medication, hip and knee replacements, and gynecological devices. Depending on the device, they can break, malfunction, leak, stop working, or not have been properly sterilized before being attached to or implanted in the patient. These design or manufacturing flaws can cause illness, infection, and/or damage to internal organs and bones, heart attacks, allergic reactions, chronic pain, and disability, among others. In some extreme cases, the faulty device may prove fatal for the patient. If you or a loved one has suffered because of a defective medical device, Ramsey Law Group is here to help. We will make sure you are compensated for your pain and suffering, including financial hardship, and also hold the company liable for this mistake accountable. Our hope with each case we bring is not only to help our client, but also to keep defective products from hurting more patients in the future.
What are medical devices?
Medical devices are any devices used for medical purposes. Medical devices help healthcare providers diagnose, investigate, disinfect, and treat; and, they also help patients get well and improve their quality of life. Common examples of medical devices you’ve likely seen before include thermometers and bedpans. More complex, high-risk devices – like a hip implant or a pacemaker – are implanted and help support the patient in living a better life. The Food and Drug Administration (FDA) allows only those products that have met its requirements to be sold in the U.S.
What are medical device dangers?
Medical devices are designed to improve and extend people’s lives; however, sometimes errors in the process can result in devices that injure patients and can even result in death. That being said, hundreds of devices have been deemed “defective” throughout the years. Commonly dangerous medical devices include:
Pacemakers that fail to keep a proper heart rhythm
A malfunctioning insulin pump
Heart valve implants that leak or break
Defective hip or knee replacement parts
Laparoscopic morcellators that spread cancer
Surgical mesh that breaks down inside the patient, damaging organs
How does the FDA approve a medical device?
The Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) oversees medical devices marketed in the United States by regulating the manufacturers and facilities. The vast majority of new devices are approved through a highly criticized lower-level process called 510(k) Fast Track Approval. The more rigorous medical device approval process is Premarket Approval (PMA). The CDRH takes an average of 276 days to approve a device through its premarket approval process.