Breast Implant Illness: Need for informed consent
Congressional District: OR06
Gastrointestinal Disease, Immune Disease
Issues and Challenges
Heidi has encountered: Access to Expert Providers, Access to Medicine, Gaslighting, Medical Devices, Medical Discrimination
My name is Heidi Rolfs and I’m passionate about helping people navigate the healthcare continuum to achieve their best outcomes. As a Registered Nurse I advocate for patient safety, healthcare transparency, and informed decision making. My experience with a common medical device encouraged me to share my personal advocacy story.
I was harmed by breast implants, a medical device that is placed cosmetically or medically into women. It is important to note that many women, including breast cancer patients after mastectomy have been negatively impacted by these devices.
I had breast implants placed in 1990, at a time when there was little consumer accessibility to research on these devices. At my surgical consult, I was handed a one-page information sheet that was written by the plastic surgery center. I didn’t receive information on the type, brand, or name of the devices and there were no serial
numbers of manufacturer information offered for my records. This information would have been useful in the event of a recall. I eventually learned that, even in 1990, there were known risks that were not disclosed during the informed consent process.
In January 1992, the FDA called for a moratorium on silicone implants and since then there have been many changes and updates including a recent Black Box Warning for these devices. Yet here we are, years later having conversations about transparency and the safety of breast implants. In August 2020, the U.S. Food and Drug Administration provided an update on adverse events that had been reported related to breast implants, including breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) as well as systemic signs and symptoms, referred to as breast implant illness (BII). Then, in 2022 another FDA safety communication came out about reports of Squamous Cell Carcinoma in the scar tissue that forms around the implant. For these reasons I am concerned about the lack of awareness by the public about the risks associated with these medical devices.
In 2013 I was an avid cyclist and a healthy woman at the peak of my career. I was healthy until I wasn’t. I began to experience joint pain, muscle weakness, overwhelming fatigue, and brain fog. It felt like someone poured concrete into my thighs and spine. I was stiff, I was dropping things due to the stiffness of my hands and simply getting up
out of a chair was difficult. I was tired all the time and struggled to focus on work. I cannot stress enough how these symptoms placed a heavy burden on my career and personal life.
In 2018 I removed my implants after developing capsular contracture of the left implant. I had also developed an autoimmune condition that’s commonly associated with breast implants. My devices were not tracked or recorded in any registry. I did not have sufficient initial informed consent about the long-term impact of implants. The doctors I
saw over the years were unfamiliar with breast implant illness and my symptoms were often dismissed. My explant operative report noted there was free flowing silicone encountered during the surgery, and this toxic substance needed to be cleaned out of my chest area. Sadly, I lost my momentum with cycling and haven’t been able to
recapture it. Due to the fatigue and exasperation with this illness I lost precious quality time with family and friends.
We need to do better! I support sufficient funding allocation for patient safety and post-market surveillance of these medical devices. Primary care physicians, rheumatologists, and other health care providers need education on the risks and side effects of these medical devices. If my doctors had been more knowledgeable about breast implant
illness, I could have removed them sooner and avoided years of illness and costly medical care. I hope this information about my experience with implants helps others understand how these devices can impact a woman’s health.
My Motivation and Inspiration
I am advocating for:
Health care accountability with informed consent around breast implants.
Awareness and knowledge of Breast Implant Illness.
ICD-10 code for Breast Implant Illness.
Awareness, knowledge, and proper treatment of BIA-ALCL.
Insurance coverage for cancers associated with breast implants.
Better campaigning on how to self-report symptoms to the FDA’s MedWatch Program.
Federal and State bills regarding medical device safety.