Health & Medicine
The Department of Health and Human Services issued the following Public Comment Instructions for FDA Essure Guidance re: Docket No. FDA-2016-D-0435]. I strongly urge all E-Sisters, Mad Men of Essure, families, supporters, doctors, caregivers, friends and anyone concerned with the crime against womens’ health known as Essure to follow these instructions and let the FDA know your opinion
An announcement from the Department of Veterans Affairs earlier this week showed that the organization is actually paying attention to some things. While it’s not patient care improvement or shortening wait times for veterans to get much needed health care, the VA took disciplinary action against appeals staffers for inappropriate conduct on the job.
Those of us who advocate for the removal of Bayer’s “permanent” birth control device, Essure, from the market, as well as the tens of thousands of innocent victims whose lives this product has destroyed have waited since September 2015 for the FDA to take action to protect innocent women. All the waiting was for naught, sadly. The FDA failed women and left deadly Essure on market.
According to the letter, plaintiffs’ counsel contacted a Mirena doctor violating court orders. Judge Seibel had previously issued a Case Management Order (CMO 21) that prohibited plaintiffs’ attorneys “from engaging in ex parte discussions with plaintiffs’ providers [doctors] concerning liability issues or theories.”
Rep. Rosa DeLauro spoke out against Essure during a meeting of the Appropriations Committee on February 25, 2016. The video – a short four-minutes – shows her impassioned speech, her tough questions to the FDA and the agency’s unsurprising lackluster responses. Though the numbers Rep. DeLauro opened with were lower than the actual numbers (but
This is the full text of a letter written by Rep. Mike Fitzpatrick (R-PA) to Dr. Jeffrey Shuren, Director, Center for Devices and Radiological Health for the FDA in which a congressman questions FDA over Essure Data.
In an unsurprising case of “duh!” federal investigators from the Government Accountability Office (GAO) came to the conclusion that the FDA is not doing well at one of its main responsibilities. The FDA is failing to properly track drugs after they hit the market. The GAO, Congress’ nonpartisan investigative department, discovered problems.
According to a statement from the FDA, “Cybersecurity threats to medical devices are a growing concern. The exploitation of cybersecurity vulnerabilities presents a potential risk to the safety and effectiveness of medical devices.” The agency has issued draft guideline to medical device makers as to how they can protect consumers from these cybersecurity issues.