21st Century Cures: Safety Concerns About Bayer’s Essure Female Sterility Implant Heighten Just Before Senate Weighs Proposal To Hasten Medical Device Approvals
Friday, September 25, 2015
Source: International Business Times
Thousands of women who received an implant to render themselves sterile have filed complaints about debilitating stomach pain and severe bleeding with the U.S. Food and Drug Administration since the device's approval in 2002. Concern among regulators and patient advocates about the safety of the product, called Essure, is reaching a turning point as the U.S. Senate prepares to consider legislation this fall that would hasten the process by which the FDA reviews and certifies medical devices.
"It's going to provide a smoother process for getting these drugs into the hands of patients but I think it's going to do that without sacrificing safety for patients and families," Jessica Crawford, president of a trade group called MedTech that represents medical technology companies in New York, says. "When you look at the FDA, it is the gold standard for drug approval and device safety across the world."
"I think at the end of the day, this is going to support more research and development for companies," she says. "This has been carefully looked at and examined because we know how important drugs and devices are to people's lives."