Joint replacements are the #1 expenditure of Medicare. The process of approving these medical devices is flawed according to the Institute of Medicine. It is time for patients' voices to be heard as stakeholders and for public support for increased medical device industry accountability and heightened protections for patients. Post-market registry. Product warranty. Patient/consumer stakeholder equity. Rescind industry pre-emptions/entitlements. All clinical trials must report all data.
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Friday, March 11, 2016

Make YOUR thoughts known now! Bayer Essure BLACK BOX warning is not enough!

This is the link:


The Food and Drug Administration (FDA) Notice: Labeling for Permanent Hysteroscopically-Placed Tubal Implants Intended for Sterilization, Draft Guidance for Industry and Food and Drug Administration Staff; Availability

My information is public and I chose 'Individual Consumer'


"In 2010, the FDA paid to fly me to Silver Spring MD for three days of training to be a CDRH (medical device) Patient Representative.  I have never been called to serve on an Advisory Panel because nearly 100% of all medical devices go through the 510(k) -aka 510 pray- clearance method.  The device manufacturer names a predicate device, submits a fee and some paperwork and the clearance is approved.  Bayer Essure coils are rare in that they were cleared through PMA which protects the manufacturer from any litigation.   The women harmed by Bayer Essure are truly sacrificial lambs.  They were not informed that there is absolutely no warranty on this product and that their basic civil rights to a jury trial are null and void.  The harm perpetrated by this German conglomerate is assured by the current proposed legislation.  The PMA should be immediately revoked so that patient rights to justice are restored.  If Bayer conducted a legitimate scientific study and the product performs (patient outcomes) as advertised, this will come out in ‘discovery’.  In any case, there should not be any more insertion of these coils until the safety and effectiveness of this device are determined.  The leadership of the CDRH is questionable, at best.  Dr. Jeffrey Shuren’s entire household income is dependent upon the medical device industry(his wife, Allison is the partner at Arnold and Porter, LLP and prepares companies for device clearance).  Dr. William Maisel was arrested and convicted of soliciting a prostitute, yet he maintains his employment and is instrumental in clearing devices for women’s pelvic health (he is a cardiologist!).  This legislation is far too little and far too late. " 


Joleen Chambers Comment Tracking Number: 1k0-8ofc-rm8e

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