What is a Medical Device?
According to the FDA, the term “medical device” refers to any medical product that is non-chemical and is meant to assist in the diagnosis of disease or other medical condition, or that cures, treats, or prevents a condition.
Medical devices actually encompass a broad array of products such as pacemakers, X-ray machines, various types of implants, and ultrasound products. Some basic medical devices include tongue depressors, bedpans, bandages, and thermometers.
Hundreds of medical devices have been deemed defective and range from breast implants and birth control patches to artificial hips and heart stents.
Other examples include pacemakers that stopped or failed to keep a proper heart rhythm; malfunctioning pain pumps or insulin pumps; heart valve implants that leak or break and require multiple surgeries or result in death; non-sterilized devices that lead to serious infections; devices that damage the immune system; defective hip or knee implants and replacement parts that lead to lead poisoning, pseudotumors, and an inability to ambulate; and gynecological devices that are improperly sterilized and that cause infection, infertility, or miscarriage.
Medical Devices In The News
What is the Purpose of a Medical Device?
Medical devices are meant to improve the quality of life for patients who have suffered some type of injury; however, a medical device may be designed and manufactured in such a way that the device leads to further injury and, potentially, long-term health effects, even death.
Although medical devices have transformed health care, when a medical device is defective, there may be disastrous consequences. Should a medical device manufacturer design and sell a defective medical device, patients may become further injured. Sadly, product-related injuries and deaths continue to occur due to defective devices, even products meant to improve patient health that were approved by the U.S. Food and Drug Administration (FDA).
When Defective Devices Lead to Revision Surgeries
There have been situations in which medical devices have caused more harm than the original injury that led to the need for the device. When this takes place, patients who are implanted with a defective device may need to undergo additional surgeries for injuries caused by the device. These procedures are known as revision surgeries.
Some patients may never recover from the damage allegedly caused by a defective device or may never return to their pre-surgery condition.
Revision surgeries are more complex and costly than the original surgeries. Revision surgery, while complicated, is an often necessary procedure that involves the surgeon first removing the original, defective medical device, which may be implanted deep in the patient’s body.
Revision surgeries are also associated with an increased rate of complications and are typically more painful. A faulty device must be surgically removed and replaced with a different device; these two surgical procedures must often be handled separately, which may leave patients bed-bound in the interim.
Patients may require longer physical therapy, and not all revision surgeries are fully covered by patients’ insurance policies.
When A Patient Suffers Injury or Death Due to A Defective Medical Device
When a patient suffers injury or death due to an allegedly defective medical device, the patient or the patient’s survivors may be able to pursue a claim and recover compensation. The attorneys at Parker Waichman may be able to help allegedly injured patients or their survivors with claims.
A defective medical device claim may be very difficult to handle without the assistance of an experienced defective medical device lawyer. Your defective medical product claim may hold various parties liable for your losses, including the medical device manufacturer, the pharmacy, the medical device supplier, and the surgeon who implanted the allegedly defective device.
When a defective medical device injures a patient, the manufacturer of that product should be held responsible for economic and non-economic losses.
By filing a defective medical device claim, injured parties or their survivors may be able to recover compensation for many different types of losses, including medical costs and future medical costs, lost wages and future lost wages, pain and suffering, and permanent disability.
Parker Waichman will help determine if the medical device was properly designed and manufactured; that proper warnings and instructions were provided to physicians and patients; that the device was appropriately tested prior to its release to the market; and that the device maker did not overstate the device’s safety, efficacy, and benefits.
When a Medical Device is Not Recalled
Some manufacturers will attempt to cover up a device defect rather than recalling the faulty device. When the defective medical device remains on the shelves of medical supply stores and in hospitals, more people will suffer.
It is then the manufacturer’s responsibility to issue a product recall; however, if this is not done, the FDA should step in and issue a product recall to remove the defective device from the marketplace. Unfortunately, this last resort often takes place after hundreds or thousands of consumers become injured due to a medical device.
Parker Waichman LLP, a national law firm, has an extensive and successful reputation fighting for its clients’ rights over defective medical devices that may lead to serious and life-altering injuries, repeat surgeries, long hospital stays and, in some cases, death.
Clients may have long periods of time away from work or may need to reevaluate their careers, financial lives, and family and social lives.
The 501(K) Clearance Process
The 510(k) clearance process has been highly criticized in recent years. This regulatory loophole bypasses clinical testing. Under this process, device makers have the ability to bypass the clinical testing of their products should a device be found to be substantially similar to a previously approved device.
Those opposed to this process argue that medical devices cleared in this manner often include devices that have high failure rates such as metal-on-metal hip device implants and transvaginal mesh devices, to name just two.
Questions Concerning Defective Medical Devices
The attorneys Parker Waichman have a long history of successfully fighting defective medical device cases for their clients. If you or someone you know has been injured or suffered losses due to a defective medical device, the firm offers legal consultations over questions about filing a lawsuit.
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