Transvaginal Mesh Deaths Reported as Injuries?

York, PA – “A good number of attorneys have reported transvaginal mesh adverse events to the FDA on behalf of their clients/patients, but over 23,000 reports are from physicians,” says Madris Tomes, founder of Device Events and former FDA Program Manager. “Physicians are not great at reporting— this is a HUGE number.”

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Device Events LLC Launches Medical Device Adverse Event Reporting Service

York, PA USA —  3 January 2017 – Device Events, LLC announced today the commercial launch and availability of their cloud-based medical device recall and adverse event search, reporting, and analysis service.

Device Events LLC, founded by Ms. Madris Tomes in 2015, provides a cloud-based software service that extracts, consolidates and provides easy access to clear and comprehensive information on the millions of medical device adverse event reports (MDRs) filed with the FDA.

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FDA mandates new warnings, new data for Essure contraceptive device

Updated 10:01 AM ET, Tue March 1, 2016

(CNN)The U.S. Food and Drug Administration said it will require a new “black box warning” label for Essure, an implantable permanent contraceptive device. A black box warning in the labeling of products is “designed to call attention to serious or life-threatening risks,” according to the FDA website.

Monday’s announcement comes after more than 5,000 women filed grievances with the FDA between November 2002 and May 2015, complaining of unintended pregnancies, miscarriages, stillbirths and severe pain and bleeding after an Essure implantation.

Click here to read more: http://www.cnn.com/2016/02/29/health/fda-essure-birth-control-device/index.html

Congressman Says More than 300 Fetal Deaths Related to Essure Ahead of FDA Announcement

Rep. Mike Fitzpatrick (R-PA) on Wednesday presented new information raising questions about the safety of the permanent birth control device Essure, claiming the number of fetal deaths related to the device are far greater than what has been reported by the US Food and Drug Administration (FDA). - See more at: http://www.raps.org/Regulatory-Focus/News/2016/02/17/24349/Congressman-Says-More-than-300-Fetal-Deaths-Related-to-Essure-Ahead-of-FDA-Announcement/?utm_source=social&utm_medium=post&utm_campaign=RFnews#.dpuf