Defective & Recalled Devices
A medical device recall is an action taken when a medical device violates a Food and Drug Administration (FDA) law, requiring the medical device to be checked, adjusted, fixed, or immediate stop of use. Recalls occur when a medical device is defective, could be a risk to a patient’s health, or both. A recall is either a correction or removal of the defective appliance. In most cases, a company, or manufacturer, distributor, or responsible party, recalls the medical device voluntarily and notifies the FDA. If the company refuses to recall, the FDA can legally require the company to recall the defective device. When an implanted device is recalled, it does not always have to be removed. However, if the implanted device has the potential to fail unexpectedly, companies often contact doctors to inform their patients of the recall, and the risk of removing the device, compared to the risk of leaving it in place. Other types of actions that may be considered recalls include: inspecting the device for problems, repairing the device, adjusting settings on the device, re-labeling the device, destroying the device, notifying patients of a problem, and monitoring patients for health issues.
Defective Medical Devices
Dangerous or defective medical devices may include faulty surgical instruments, implants, pacemakers, and prosthetics. These defective products and its manufacturers can be held liable if a person is injured or dies as a result of these devices. Typically, the FDA evaluates new products with strenuous premarketing testing. However, this process can deviate from if the manufacturer can exhibit that the product is “substantially equivalent” to a product already on the market. This sidestep of FDA approval is known as a system called the 501(k) program. If this is proven, a new medical device can be put on the market and implanted in patients without any clinical testing or review of the product’s outcomes. The 501k clearing process allows patients to have quick access to new products in medicine without proving their safety and effectiveness.
There are several known defective medical devices on the market that have sparked lawsuits. These defective devices include transvaginal mesh, power morcellator, hip replacements, Mirena, and Stryker hip replacements.
Transvaginal mesh was created to treat protruding hernias before surgeons started using it to treat pelvic organ prolapse and stress urinary incontinence. Transvaginal mesh is primarily made from a synthetic plastic-like material, or stainless steel and biological materials. It can be implanted in the abdomen or vaginally. However, as a result of vaginal implantation, many women have experienced organ perforation and erosion, or disintegration of the mesh.
Power morcellators are devices used to treat women with the removal of noncancerous growths or total hysterectomy, Replacement isto treat painful or troublesome symptoms. The power morcellator breaks up fibrous tissue from the uterus and is used in hysterectomies to sever muscles that hold the organ in place.
Hip Replacement technology is used to reduce pain in patients and increase their mobility after devastating injury or disease. However, faulty devices on the market may end up hurting the patient, rather than healing them. Inferior product design or mistakes made by the surgeons and doctors could lead to serious complications for the patient. Often, manufacturers of these devices fail to warn the public about the risks they may face when receiving a hip replacement.
Mirena is a T-shaped uterine device (IUD) used for long-term contraception. This hormonal device thickens the mucus in the cervix and prevents pregnancy. After insertion, pregnancy may be prevented for up to five years. Consequently, infections, damage to organs, adhesion and hemorrhages may occur if the product perforates or migrates into the pelvic areReplacement is
Stryker Hip a joint replacement surgery used to renew mobility in elderly people suffering from osteoarthritis and other degenerative conditions. This defective device may cause increased metal content in the blood, bone degeneration, pain, and the need for revision surgery in a patient.