There are numerous medical devices that enhance people’s lives on a daily basis, but there are also a number of instances in which medical devices have caused more harm than good. Defective and recalled devices are those that have caused injury or illness to people using the devices or receiving treatment from the devices.
When a medical device has been shown to be harmful, the manufacturer of the device can voluntarily issue a recall. If that does not occur and the device violates safety regulations, the US Food and Drug Administration (FDA) can issue a recall. The FDA requires dangerous devices be fixed, adjusted, further tested, or taken out of use for the protection of the general public.
In some cases, recalled devices have already been placed inside of patients. An example of this would be a device intended to repair a joint in the body, such as the hip or knee. In these cases, the device does not necessarily need to be removed and/or replaced, though this might be the case eventually if a device fails and poses a risk to the patient. It’s important to realize that in every cases, removal of a defective medical device poses some danger, so it’s up to the patient and his or her doctor to determine if the benefits of removal outweigh the risks of the removal procedure.
Over the years, a variety of medical devices have been deemed defective. Many were recalled. Some examples of defective devices include:
- Surgical instruments
- Prosthetic limbs
- Birth control devices
When a device is deemed defective and determined to pose a risk to patients, the manufacturer of the device can be held liable if the user is injured or dies as a result of using the device. Anyone who is injured or made ill by a medical device is encouraged to seek experienced legal counsel and discuss the various options available to gain compensation for medical treatment, pain, and suffering.
In general, the FDA must approve all medical devices that are available for doctors and patients to use. Unfortunately, the approval process can be confusing and in some cases, medical device manufacturers are able to sidestep parts of the process and send products to market without thorough testing or evavluation. This is the case with the FDA’s 501(k) approval program.
In the 501(k) approval program, a device manufacturer can send a device to market without testing or official approval, as long as there is a similar product already on the market. The benefit of this program is it gives patients quick access to the latest technology in medicine – something that for some people is necessary for survival.
However, there are also cases in which rushing a product to market creates a number of problems for patients. There have been numerous instances in which a rushed-to-market device that was approved through the 501(k) program did not perform as expected and patients were injured or made ill.
Legal Action Related to Defective Medical Devices
There are several medical devices in use today that are considered defective. In some cases, recalls have alerted patients to the dangers of these devices and in more extreme cases, the FDA has encouraged doctors to no longer use these devices. Often, legal action spikes once a recall of a product is announced because the public is made aware of the dangers related to various devices.
Examples of dangerous medical devices facing legal action at the moment include:
- Transvaginal mesh
- Power morcellators
- Hip replacements
- Mirena birth control
- Stryker hip replacements
If you or a loved one has been harmed by a medical device – either a tool used in a surgical or medical procedure, or a device that was implanted into your body – you have a right to take legal action. In many cases, these devices have altered the course of the affected person’s life forever. Many who believed they were undergoing a medical procedure to improve their life now deal with pain and suffering on a daily basis.
Filing a claim against the manufacturer of a defective medical device can help you pay for medical treatment that might include follow-up surgeries, medication, or physical therapy. It’s also possible to receive compensation for pain and suffering and lost wages. Our goal is to inform the public about defective medical devices and help them determine the best course of action if they are injured or harmed by a defective device.