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The recall came after data from a study indicated that the five year failure rate of this product is approximately 13%, or 1 in 8 patients. [3] Even if the defective device is replaced, it can leave behind dangerous, possibly deadly fragments that may not be discovered for years.
On February 10, 2011, the U.S. FDA issued an advisory on metal-on-metal hip implants, stating it was continuing to gather and review all available information about metal-on-metal hip systems. [67] On June 27–28, 2012, an advisory panel met to decide whether to impose new standards, taking into account findings of the study in The Lancet.
Limited number of episodes of abnormal activity can be stored, [2] with the most recent episode replacing the oldest. [3] Recording can be activated in two ways. First, recording may be activated automatically according to heart rate ranges previously defined and set in the ILR by the physician. If the heart rate drops below, or rises above ...
The FDA said the recall of the device BioZorb Marker, initiated by Hologic in March, was not a product removal, but a correction. The agency also urged patients to report any side effects they ...
An additional 1,000 more complaints have been sent to the FDA in a voluntary reporting system, but physicians are not obliged to report complaints. [ 5 ] In June 2015, the FDA reported an investigation into Essure and its over 5000 complaints, seven reported deaths, and many additional side effects, all linked to Essure, its specific chemical ...
Botched 's first season, consisting of eight episodes, ended on August 17, 2014. A two-part reunion special hosted by Maria Menounos aired on October 26 and 27, and featured interviews with Dubrow, Nassif, and patients from the series.
A harness problem has led to one company to recall more than 50,000 children's car seats across the country. Over 50,000 child safety seats recalled Skip to main content
Poly Implant Prothèse (PIP) was a French company founded in 1991 that produced silicone gel breast implants.The company was preemptively liquidated in 2010 following the revelation that they had been illegally manufacturing and selling breast implants made from cheaper industrial-grade silicone since 2001 (instead of the mandated medical-grade silicone they had previously used).