In mid-January the U.S. Food and Drug Administration approved a first-of-its-kind device to treat obesity, according to a FDA press release. The device, known as the Maestro Rechargeable System, realigns nerve pathways between the brain and the stomach. It’s the first FDA-approved device to fight obesity since 2007, and is approved for patients who have a body mass index of 35 to 45, with at least one other obesity-related condition. One such condition would be Type 2 diabetes.
1 in 10 hip replacement surgeries fail, forcing the patient to undergo risky revision surgery. If the hip implant fails, it usually infects the bone. In the subsequent osteotomy, the doctor must remove both the defective implant and the infected bone. That bone loss makes the revision surgery a very low-percentage gamble, because there is not enough remaining healthy bone to anchor a second implant.
Though the manufacturer has come under fire for defective devices in the past, this year the da Vinci Sp Intuitive single port robot system used in surgical procedures is expected to hit the consumer market, according to MedGadget.com. The system is designed to allow for single-incision surgeries, and is a competitor to manufacturing giant Titan.
Prescription drug manufacturers are responsible for proper development of their products and the marketing and labeling it presents to the public. If there is a chance that their drug is defective, it can result in a recall and, ultimately, harm to patients.
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.
When new products or medical devices are considered for approval for the consumer market, manufacturers must first undergo a rigorous system to have the device approved. The U.S. Food and Drug Administration (FDA) divides approved medical devices into three categories: Class I, II, and III. Class I devices are not subject to as much regulatory control as Class III—Class III devices are usually those which carry a greater risk to the patient or consumer.
Surgical mesh was developed in the mid-20th century as a way to treat hernias. The implant was originally intended to be placed beneath the skin to patch the hole in the abdomen and block intestines and other tissues from protruding, according to the U.S. Food and Drug Administration. It can be made from either biological or synthetic materials.
A recent report shows the number of recalled medical devices continuing to increase. In response, many watchdog and consumer protection groups are aiming to make stricter requirements for medical devices.
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).
Official warnings have been handed out to several companies advertising autism therapies and cures. Five total treatments were flagged in the statement from the FDA, which was announced during Autism Awareness Month. While some of the therapies are noted as useful medical therapies, there have not been scientific studies that show a connection to autism improvement.