The Medical Device Safety Act 2019 H.R. 2669

The bill would amend the Federal Food, Drug, and Cosmetic Act with respect to liability under State and local requirements respecting all Class III devices. Including, but not limited to Essure, nerve stimulators, hip implants, defibrillators, pacemakers, infusion pumps, surgical mesh, cochlear implants, and breast implants. This bill is identical to The Medical Device Safety Act of 2009 that Senator Ted Kennedy introduced after the 2008 Riegel vs. Medtronic ruling, which had 23 cosponsors. Kennedy immediately recognized that the Supreme Court's interpretation of the Medical Device Amendment was inappropriate. However, when Kennedy passed away, the bill never went to vote.

Read more about H.R. 2669 and sign the Petition here.

The Medical Device Guardians Act of 2019 H.R. 2915

We are asking for your support of The Medical Device Guardians Act H.R. 2915. This bill will REQUIRE physicians to file an adverse event report with the FDA when they see a patient that has or had an adverse event from a medical device.

Currently, this is NOT a requirement!  Requiring this action will help to ensure that the FDA quickly flags devices that are causing injury or death.

Read more about H.R. 2915 and sign the Petition here.

JAMEE COOK

Jamee Cook is a wife and mom from Texas. She worked as a paramedic in the state of Texas for 11 years but now spends most of her time volunteering as a patient advocate.

Jamee was implanted with PIP textured saline implants in 1998 in Dallas, TX. After a couple of years, she began to get sick. Plagued with random symptoms, she sought medical help but couldn't find any answers to explain her deteriorating health. In 2015, she removed her implants and the majority of her symptoms went away immediately. Jamee co-founded Breast Implant Victim Advocacy (BIVA) to raise awareness of illness and complications that can accompany silicone and saline breast implants, including a heavy focus on Breast Implant Associated Anaplastic Large Cell Lymphoma. In July 2016, she held the first Dallas Conference on Breast Implant Illness.  BIVA has met with the FDA breast implant advisory team on three separate occasions and attended the March 2019 Advisory Committee Panel Meeting as an agenda speaker. 

Jamee is on the Board of Directors for the USA Patient Network and works on a national level with multiple patient advocates, covering a wide array of topics including patient harm, pharmaceutical and device regulation, etc.. She is a breast implant representative and administrator for the Medical Device Problems group and website that developed in conjunction with the documentary, The Bleeding Edge. Other administrator roles on social media include a patient support group for BIA-ALCL and a Clinician/Patient Discussion Group for BIA-ALCL. She also created the Breast Implant Illness and Problems Texas group.

Most recently, Jamee joined a newly formed FDA Breast Device Collaborative Community which includes multiple plastic surgeons and organizations. BIVA has over 6,500+ followers on Facebook and has been referenced in multiple media pieces - both in print and online. BIVA and Just Call Me Ray work hand in hand to raise awareness globally. They often work under the guidance of the National Center for Health Research. Her primary goal is patient education / informed consent, improved device regulation, better study participation, and wants to bring more attention to the percentage of women who actually get sick or develop BIA-ALCL. She hopes to accomplish this through a collaborative effort with surgeons, FDA, and industry, and is also currently working on a large scale patient driven registry.