The Federal Food and Drug Administration (“FDA”) is the agency in charge of monitoring medical devices in the United States. According to the Federal Food, Drug and Cosmetic Act, there are at least 1,800 categories of medical devices.
Before medical devices become available for public use, the manufacturer must first obtain approval for marketing that product from the FDA. In order to obtain approval, the manufacturer must prove that the device is safe and effective before being marketed. Unfortunately, though, the FDA’s decision as to whether to approve a device for marketing is completely dependent upon the information that is provided by the manufacturer. Many times this information does not tell the whole story about the safety of a product. Moreover, the basis for the conclusions made by the manufacturers is sometimes based upon minimal information.
Typically, the clinical trials upon which premarket approval is based, may only involved a small number of patients. More importantly, most medical devices are not tested practically, or in real life situations. Therefore, even if the FDA grants premarket approval to a device manufacturer, healthcare professionals and the public at large cannot assume that the FDA has determined that the product is absolutely safe for human use.
The following is a list of potentially defective medical devices that the Falkowitz Law Firm believes may be harmful and is, therefore, investigating claims against its manufacturers:
- Artelon Spacers
- Bair Hugger Warming Units
- Cochlear Implants
- IVC Filters
- Medtronic Infuse
- Metal on Metal Hip Implants
- Pain Pumps
- Power Morcellators
- St. Jude Defibrillators
- St. Jude Leads
- Stryker OP-1
- Transvaginal Mesh
Any kind of defective medical device lawsuit requires review by an experienced attorney. Only an experienced personal injury attorney has the skills to handle a case like this. An attorney can take depositions, subpoena records, hire expert witnesses, and more.
If you’ve suffered a serious injury as a result of a defective medical device, you have valuable legal rights. Questions? Call the Falkowitz Law Firm any time for a free consultation.