Medical Devices

The Food and Drug Administration should stop permitting thousands of medical devices to be marketed and used in patients without proof of safety or effectiveness, the National Academy of Sciences said Friday. The academy's report, coming after a spate of recalls and problems with such devices, pointed up a little-known quirk in the law. In theory, the FDA has broad responsibility to ensure that drugs and medical devices are safe and effective. But thousands of devices go through an expedited review because they are considered similar to older devices that are already on the market.

Imagine having the fountain of youth as close at hand as the bathroom. We're not there yet — but there's a burgeoning number of at-home, high-tech beauty gadgets that claim to smooth wrinkles, whiten teeth and remove hair without the need to invest in pricey beauty treatments at the spa, dermatologist or plastic surgeon's office. Some of these gadgets are so high-tech the Food and Drug Administration considers them medical devices, so approach the world of cosmetic gadgetry with caution.

WASHINGTON – Following a spike in reported complications, the Food and Drug Administration released an updated advisory Wednesday about a surgical mesh implanted in women to strengthen vaginal tissue that can become weakened, especially after childbirth. In its report, the FDA says a review of industry literature and the adverse event reports has shown little evidence that the device, which is implanted vaginally or abdominally, improves pelvic organ prolapse, where a woman's uterus, bladder, or rectum can slip out of place.

The Food and Drug Administration says it could use an international helping hand in testing the influx of imported drugs and food.  Acknowledging the monitoring difficulties inherent in a global economy, the agency said in an announcement Monday that it needs to transform the way it protects the nation's food and drug supply, teaming up with other agencies around the world to ensure quality and safety of the products it regulates. “Global production of FDA-regulated goods has exploded over the past ten years.  In addition to an increase in imported finished products, manufacturers increasingly use imported materials and ingredients in their U.S. production facilities, making the distinction between domestic and imported products obsolete,” Commissioner of Food and Drugs Margaret A. Hamburg said in the announcement.

Reporting from El Cajon, Calif. -- Sharlotte Hydorn peddles a product touted for its deadly simplicity. Inside her butterfly-decorated boxes are clear plastic bags and medical-grade tubing. A customer places the bag over his head, connects the tubing from the bag to a helium tank, turns the valve and breathes. The so-called suicide kit asphyxiates a customer within minutes. Orders come from all over the world, from people young and old, depressed and terminally ill. "People commit suicide by jumping out of windows and buildings, and hanging themselves," said the 91-year-old former elementary school science teacher.

The Food and Drug Administration announced Monday that it will act to ensure the government's right to impose marketing, manufacturing and safety restrictions on "electronic cigarettes," a nicotine delivery device widely billed as an alternative to cigarettes for those trying to quit and for smokers who can't light up. In a letter posted to the FDA's website Monday, Dr. Lawrence R. Deyton, director of the FDA's Center for Tobacco Products, said...

Despite recalls of defective medical devices that have caused devastating injuries and millions of dollars in medical costs, the Food and Drug Administration is under industry pressure to speed up its approval process. That pressure comes as a new Government Accountability Office report criticized the way the FDA handled approval of high-risk devices, such as defective artificial hips made by Johnson & Johnson that left shredded metal in patients. More than 90,000 artificial hips were recalled last summer after studies showed that about 1 out of 8 recipients needed to have them replaced.

Brain tumors may soon encounter a new weapon. The Food and Drug Administration has approved a new device that uses electrical energy to kill brain cancer cells. The device, approved for those who have malignant tumors known as glioblastoma multiforme, adds a potential new alternative to chemotherapy for patients with advanced brain tumors. The device, called NovoTTF, delivers low-intensity electrical fields directly to a patient’s scalp via four electrodes. The electrical fields appear to interfere with the process of cell division, halting the tumor’s growth.

The Food and Drug Administration has been allowing medical devices, from hip replacements to external defibrillators, to enter the market under less stringent review processes -- and this may mean potentially unsafe devices are being used by, and even implanted in, unsuspecting patients, a new report finds. According to the report released Wednesday by the Government Accountability Office, medical device makers don't have to go through the FDA's stringent premarket approval process if they can show that their product is roughly equivalent to another device already on the market.

A disproportionate number of medical devices recalled because of possible links to serious health problems or deaths ? including external defibrillators and insulin infusion pumps ? were approved under an abbreviated process that did not require advance testing on patients, according to a five-year study of such recalls. More than 70% of the 113 recalled devices were cleared for market under a shorter Food and Drug Administration review because they were deemed similar to products already on the market, the study found.