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FDA: Lapdog Enforcement on Reporting Adverse Events

Lapdog, Portrait of Woman in Red, Agnolo Bronzino, 1532, Tuscan School, WikiCommons Mesh Medical Device News Desk, March 7, 2017 ~ In mild mannered newly-issued language, The U.S. Food and Drug Administration (FDA) recommends that medical device manufacturers report adverse events to the agency, but it's not legally [...]

By |2017-03-07T10:44:31+00:00March 7th, 2017|FDA News|7 Comments

FDA Finally Reclassifies Pelvic Mesh Tools

Surgical tools, FDA Mesh Medical Device News Desk, January 16, 2017~ Pelvic mesh tools used to place and affix transvaginal mesh had been a low-risk FDA category alongside Band-aids. Because of injuries, it's been placed in a class II or moderate-risk category.  Tools used to place transvaginal mesh [...]

By |2017-01-23T12:30:21+00:00January 16th, 2017|FDA News|16 Comments

FDA Pelvic Mesh Data – Are Thousands of Deaths Not Being Reported?

Madris Tomes, Device Events Mesh Medical Device News Desk, December 5, 2016 ~ A former FDA IT project manager left the agency to focus on patient safety and on finding the numbers needed for true patient safety and advocacy. Imagine 5.6 million pieces of data collected by the [...]

By |2019-02-14T12:38:19+00:00December 5th, 2016|FDA News|17 Comments

Essure Birth Control Gets FDA’s Strongest Warning

Essure, ABC, Tampa Mesh Medical Device News Desk, November 15, 2016 ~ The U.S. Food and Drug Administration has approved a label change on Essure Birth Control that includes the strongest warning a device can carry.  Known as a Black Box warning, the label change will now clearly warn [...]

By |2016-11-15T12:43:23+00:00November 15th, 2016|FDA News|5 Comments

FDA Covers for Device Makers, Keeps Injuries Under Wraps

FDA Office of the Commissioner, Silver Spring, MD Medical Device News Desk, October 20, 2016 ~ The system is supposed to be transparent.   Medical device makers are required to alert the U.S. Food and Drug Administration (FDA) when their products injure consumers or malfunction.  The FDA then theoretically alerts [...]

By |2016-10-20T13:33:06+00:00October 20th, 2016|FDA News|4 Comments

ProteGen – The First Mesh, a 20 Year History

Family Tree of Meshes, Littman Mesh News Desk, July 25, 2016 ~ ProteGen – The Grandmother Mesh Of the sixty or so pelvic meshes that were or currently are on the market in the United States you may not have heard of the ProteGen mesh, a model designed and manufactured [...]

By |2017-09-15T23:33:00+00:00October 3rd, 2016|FDA News|11 Comments

FDA Funding: Medical Device Makers and Lap Dog Watchdogs

Consumers Union Safe Patient Project Mesh Medical Device News Desk, August 29, 2016 ~ The medical device industry and the U.S. Food and Drug Administration (FDA) have reached tentative agreement on $1 billion in funding from the very industry it regulates. The Medical Device User Fee Agreement IV [...]

By |2016-08-29T13:50:55+00:00August 29th, 2016|FDA News|15 Comments

FDA Says it’s Taken 21,000 reports of Wen Hair Care Complaints

Mesh News Desk, July 20, 2016 ~ The U.S. Food and Drug Administration says it has received 127 adverse event reports about the WEN Hair products. Promoted on television by celebrity stylist, Chaz Dean, the FDA says his office has received 21,000 complaints. Complaints include reports of balding, rashes and [...]

By |2016-07-20T14:06:42+00:00July 20th, 2016|FDA News|7 Comments