More than 95% of medical devices on the market were not required to be proven safe or effective. Less than 5% are required to be studied in clinical trials. Our goal is to improve the safety and effectiveness of all medical devices sold in the U.S. and educate healthcare professionals and patients about known and unknown benefits and risks of each device.

Coalition Letter to MAP workgroups on CT quality measures

We are writing to enthusiastically support the CT quality measures developed by researchers at the University of California, San Francisco: Excessive Radiation Dose or Inadequate Image Quality for Diagnostic Computed Tomography (CT) in Adults.

Statement on Behalf of Members of the Patient, Consumer, and Public Health Coalition at the FDA Advisory Committee on Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA-ALCL) and Informed Consent

FDA has been slow to recognize the full impact of BIA-ACL and needs to do more to protect women from it. The delayed intervention of the FDA and surgeons everywhere on this matter is too serious to ignore.  For those women who were barely informed of these severe risks, it has had terrible and sometimes fatal consequences.

Statement on Behalf of Members of the Patient, Consumer, and Public Health Coalition at the FDA Advisory Committee on Vaginal Mesh

Our Coalition strongly supports FDA’s decision to require a pre-market approval review, including clinical trials, to determine the long-term safety and effectiveness of trans-vaginal mesh for pelvic organ prolapse repair. These products were initially allowed on to the market as substantially equivalent to mesh used in other parts of the body, under the 510(k) approval pathway that does not usually require clinical trials or direct scientific evidence of safety or effectiveness.

Comments of Members of the Patient, Consumer and Public Health Coalition on “Manufacturer Communications Regarding Unapproved Uses of Approved or Cleared Medical Products”

We strongly oppose allowing companies to promote medical device products for off-label uses. There are not adequate safeguards to allow such promotion to be limited to only scientifically sound, complete and unbiased data. While some patients are helped by off-label uses, many also are harmed by the same poorly-regulated practices.

Coalition Supports Proposal to Notify the Public About Emerging Safety Issues with Medical Devices

We support the draft guidance, Public Notification of Emerging Postmarket Medical Device Signals (“Emerging Signals”). The draft guidance addresses a serious problem: the delay between early signals that a device is less safe or less effective than expected, and the development of confirming evidence that the FDA would like to have before making recommendations. But in the months or even years during that delay, patients can be and too often have been seriously harmed.