#Icad fda approval trial

вЂњYou canвЂ™t always identify problems before the marketplace.вЂќ вЂњItвЂ™s got a good safety record,вЂќ said David Nexon, senior executive vice president of the Advanced Medical Technology Association, an industry lobbying group also known as AdvaMed. Medical device manufacturers defend the 510 (k) process, saying less than 1 percent of the estimated 3,000 to 4,000 devices cleared each year are recalled because of concerns about death or serious injury. In a letter to hospitals last year, XoftвЂ™s director of regulatory affairs wrote, вЂњWe have determined that the toxicity of these very pure tungsten particles is low as few health effects have been reported in humans.вЂќ Among the possible defenses to the lawsuit they listed were that the injuries were the plaintiffsвЂ™ own fault or the fault of the hospital. In a response to the injury lawsuits filed in Orange County Superior Court, Xoft and iCAD have denied any negligence or liability. Xoft, the shield manufacturer, and its parent company iCAD, declined requests for an interview. Hoag also noted, in court filings, that they had warned patients in a written disclosure that the treatment they would receive was new and its safety was unproven. вЂ¦ The highest quality patient care and safety are absolute top priorities at Hoag.вЂќ In addition, as soon as the physicians and Hoag clinical trials staff became aware that there were concerns about the device, they immediately notified the FDA.

#Icad fda approval trial

Jack Cox, chief quality officer at Hoag, told The Orange County Register in a statement: вЂњThe physicians involved with the clinical trial took immediate action upon discovering the situation and notified all of their patients involved in the clinical research trial.

Melvin Silverstein, medical director of Hoag Breast Care Center and KellyвЂ™s surgeon, declined requests to be interviewed for this article, citing lawsuits against Hoag by Kelly and 12 other patients.Д«ut Dr. вЂњThe 510 (k) program is the weakest and most nonsensical program in the FDA.вЂќДr. вЂњPatients and doctors would be shocked to learn how this is done,вЂќ said Diana Zuckerman, president of the National Research Center for Women and Families. In other cases, new inventions have been cleared even though they were similar to devices that proved faulty after their release. The tungsten FlexiShield, for instance, was approved based on another product made from a different metal. But there is a lot of leeway in that rule. The process clears new inventions if they are вЂњsubstantially equivalentвЂќ to devices already on the market. Regulators, independent reviewers, doctors and consumer advocates agree that the 510 (k) process is seriously flawed. Today, about 90 percent of the devices on the market are cleared for use through the 510 (k) process, FDA officials say. But after extensive lobbying by medical manufacturers, Congress changed the regulations to make it even easier to get clearance. The 1976 law was intended to provide quick approval of low- and moderate-risk medical devices. The alarming outcomes brought new fuel to a longstanding debate over an FDA rule, known as 510 (k), that allows manufacturers to fast-track new medical devices to market without human testing. One report described the metal as вЂњapparently вЂ¦ debris left from the tungsten shield.вЂќ Since the recall, the number of patients reporting a metallic or powdery substance in their breasts has risen to 29. вЂ“ reported to the Food and Drug Administration that a metallic, powdery substance was found inside the breasts of 10 women treated with the device. Xoft voluntarily recalled the Axxent FlexiShield in February 2011, after two of the first hospitals to use the device вЂ“ Hoag and Karmanos-Crittenton Cancer Center in Rochester Hills, Mich. It was the most frightening thing I ever heard,вЂќ said Kelly, an Irvine psychologist.

вЂњEven though the day I had my surgery the cancer was removed, something potentially worse was put inside of me. Some of the metal subsequently migrated to her urine, medical records show. Instead, tungsten particles from the shield had been driven into her breast during the procedure.

FDA rule clears medical devices without human testing вЂ“ Orange County RegisterД«ut this time, cancer wasnвЂ™t the invader.