The U.S. Food and Drug Administration (FDA) issued its largest recall of medical products ever in 2014, according to the Regulatory Affairs Professional Society (RAPS). The recall, posted to the FDA’s website in August, was of 233 Class I products manufactured by Puerto Rico-based Customed.
In August, two U.S. senators began pressing the Food and Drug Administration (FDA) to take power morcellators off the American medical device market. According to the FDA, laparoscopic power morcellators are used to help remove tissue through small incision sites, and are most commonly used in hysterectomies or during the surgical removal of uterine fibroids (myomectomy).
When the antidepressant drug Paxil hit the consumer market in the early 1990s, it was hailed by the medical world as a wonder drug, able to relieve even the most severe cases of mental depression. Like most other antidepressants, Paxil is a selective serotonin reuptake inhibitor (SSRI). There have been widely-publicized side effects about SSRIs for the patient who takes them. However, not as much has been published about the effects SSRIs can have on babies born to women who are taking them.
Finding out that you or a loved one has suffered injuries or requires additional procedures to correct problems from a defective medical device is frustrating. There are certain steps you need to take to protect yourself and to have the best chance of getting the company to recall or fix defective devices.
New data shows that a company manufacturing cochlear implants distributed defective products to adults and children for many years. Unfortunately, this is just one example of defective medical devices that cause injury to people all over the world.
Johnson & Johnson has agreed to pay $2.2 billion to settle charges with the U.S. Department of Justice over the alleged illegal marketing of Risperdal, Invega and Natrecor. Johnson & Johnson has been accused of improperly promoting the antipsychotic drug Risperdal for the elderly, children, and people with developmental disabilities. The Food and Drug Administration had only approved the drug for limited pediatric uses in 2006.
When industry giant Medtronic Inc. announced that it had come up with an implant known as INFUSE, that could potentially replace the bone graft procedure, it was big news in the medical world. The Food and Drug Administration, which regulates procedures such as these, approved INFUSE for use in spinal surgery, specifically in a lower spine operation known as an anterior lumbar interbody fusion. Medtronic, however, had other ideas for INFUSE. One of these was in dental restoration surgery.
Though medical devices are meant to help those who need them to live healthy and productive lives, there are risks involved in the use of a medical device. If the device does not work properly, is not used properly, or begins to break down, it can cause more problems for the person using it. The following will help you understand what makes a medical product defective, and what to do if you encounter a defective device.
In order to bring up the issue of a defective medical device in a court of law, it must be defective in one of the two following ways: