Presentation: FDA History- Then and Now
Jamee Cook is a wife and mom from Texas. She worked as a paramedic for 11 years but now volunteers as a patient advocate. She received PIP breast implants in 1998. After several years, she began to get sick. Plagued with symptoms, she sought medical help but couldn't explain her deteriorating health. In 2015, she removed her implants and most symptoms disappeared. Jamee co-founded Breast Implant Victim Advocacy (BIVA) to raise awareness of illness and complications that accompany silicone and saline breast implants, including a focus on Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA-ALCL). BIVA has met with the FDA breast implant advisory team on multiple 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 nationally with patient advocates, covering topics including patient harm, pharmaceutical/device regulation, etc.. She is a breast implant representative for the Medical Device Problems group/website that developed in conjunction with the documentary, The Bleeding Edge. Other administrator roles on social media include a patient support group and a Clinician/Patient Discussion Group for BIA-ALCL. She also helps admin the Breast Implant Illness and Problems Texas group. Most recently, Jamee joined a Breast Device Collaborative Community which includes plastic surgeons, organizations, and industry. BIVA has over 8,500+ followers on Facebook and has been referenced in multiple media pieces - in print and online. Her goal is patient education / informed consent, improved device regulation, better study participation, and wants to bring more attention to the subset of women who get sick or develop BIA-ALCL. She hopes to accomplish this through a collaborative effort with surgeons, FDA, and industry.