We live in a miraculous age. Modern medicine has made things possible that used to exist only in science fiction, and medical devices play a large role in those advances. Unfortunately, defective medical devices are far too common and are known to cause devastating and sometimes fatal injuries.
When device makers rush devices to market, in order to profit more quickly, the defects may not be detected until a large number of patients have been injured or killed. If you have been harmed by a defective medical device, you may be entitled to significant compensation for your injuries.
Types of Defective Medical Devices
Examples of some of the medical devices that have been recalled the subject of lawsuits because they caused injury or death include:
- Implanted defibrillators
- Surgical mesh
- Hernia mesh
- Bladder sling/transvaginal mesh
- Drug eluting stents>
- Hip implants
- Knee implants
- Pain pumps
- Intrauterine contraceptive devices (IUDs)
- Sanitary wipes
- Surgical robots
Expedited FDA 510(k) Clearance Process
The majority of medical devices that go on the market do not receive FDA approval. Instead they go through an expedited clearance process that allows them to be sold without the rigorous and lengthy approval process which includes extensive testing and clinical trials.
A new medical device must be similar to an approved device in order to be eligible for 510(k) clearance. However, it often turns out that the original device was defective, even though it did go through the approval process.
Dangers of Defective Medical Devices
The harm caused by a defective medical device depends on the nature of the defect as well as the purpose of the device. For instance, if a pacemaker or implanted defibrillator fails the result can be immediate death. Some examples, although certainly not the full range, of harm that is caused by defective medical devices include:
- Device, such as implanted defibrillator, fails to perform or activates when it should not
- Device fails and must be replaced requiring additional surgery
- Multiple revision surgeries
- Heart attack
- Recurrence of the condition the device was meant to correct
- Damage to tissue, bones, or organs
- Health problems throughout the body, such as metallosis caused by debris from metal-on-metal hip implants
- Chronic pain
- Permanent disability
- Significantly decreased quality of life
If you have been harmed by a medical device, or if someone you love died from medical device injuries, you can learn more about your rights and how you can recover damages for your losses by searching our directory to find an experienced defective medical device lawyer who can evaluate your claim.