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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Wednesday, October 14, 2015

NYT Editorial: FDA/CDRH STOP Bayer Essure Harm!


Safety Questions About a Birth Control Device

By THE EDITORIAL BOARD OCT. 14, 2015
The Food and Drug Administration convened a panel of experts last month to examine the safety and effectiveness of a device for permanent birth control that has generated thousands of complaints from women who say they were harmed by it.
The device, known as Essure, is implanted in a woman’s fallopian tubes to induce scar tissue formation to block the tubes and prevent eggs from being fertilized. It is an alternative to procedures that tie or cut fallopian tubes, and some 750,000 women have received the device around the world, mostly in the United States.
The American College of Obstetricians and Gynecologists considers Essure as effective as surgical procedures and safer in some respects. Planned Parenthood considers it an important option.
More than 5,000 women have reported harmful effects to the F.D.A. (this is very likely an undercount since many problems go unreported). According to the advisory committee’s summary, patients have reported persistent pain, bleeding, allergic reactions and the need to remove a faulty device and repair any damage. There have also been hundreds of unwanted pregnancies. The risks of removal are unknown because various techniques have not been evaluated in clinical studies. Many women out of desperation had hysterectomies, which they said eased their symptoms.
In addition to these complaints, a petition has been submitted to the F.D.A. by a Florida law firm claiming that the small company that developed the device committed fraud by manipulating data in the clinical trials that led to F.D.A. approval. The F.D.A. sent the complaint to its own compliance office. That is not good enough. The charges need to be investigated by an independent office free of influence from the F.D.A., like the inspector general of the Department of Health and Human Services.
The manufacturer, Bayer HealthCare Pharmaceuticals, which acquired the device in 2013, argues that the percentage of women reporting problems is low and that many of the problems are unrelated to the device.
All birth control measures carry risks and benefits. What women and doctors need to know is how this device compares with surgical procedures and intrauterine devices in preventing pregnancies and causing minimal harm. The F.D.A. needs to look hard for ways to get that information and should consider suspending sales of Essure until better data is available.

http://nyti.ms/1ZDcQCZ

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