I’m Lisa Rohland, a surgical technologist and first assistant for the past 24 years from Mesa, Arizona, and founder of the Arizona breast implant and illness information page.
In just eight months I’ve helped over 500 sick women connect with each other and find qualified explant surgeons.
Informed consent is the most important conversation that patients have with their surgeons. We must improve the consent procedure for breast augmentation with implants. Few patients are health literate.
The consent form used by the ASPS [American Society of Plastic Surgeons] is written at a collegiate level. Reading this 13-page form took me 1 hour and 48 minutes.
At this meeting in 2002, a video-based informed consent procedure was suggested that permitted a woman to scrutinize the data from the skeptical, not the supportive. This is technologically possible now more than ever.
Risks like fatigue, hair loss, migraines, memory loss, and autoimmune disorders may have been minimized in the consent process, so [and] the implant handbook that I never received. I remember my surgeon saying that these risks never really happen. Then he had me sign and initial a single-page consent form acknowledging that I understood all my risks.
I loved my new saline implants but quickly became ill.
I spent years apologizing to my children with tears in my eyes that I wished I could be the mother that they deserved. I have almost completely healed since my explant eight months ago.
I’ve listened to the testimony of multiple women within the last year that were part of implant studies. I continue to hear that as soon as adverse effects were reported, patients would receive a letter that they suddenly have been dropped from their implant study or were just never contacted again.
Several women have been removed from the study just two years into their 10-year study. We’ve recently learned that women reporting adverse effects directly to the FDA had their data placed into a repository. As a result, all of that information has still not been made public, not to patients, not to doctors, and not to the media.
Transparency regarding adverse effects and the chemicals contained in these implants is essential for women making informed decisions. Patients need to be told about all potential risks for autonomy and the informed consent process, otherwise it is the surgeon and the manufacturers that are making these decisions on behalf of the patient, regardless of how small that risk might be.
I’d like to help you form an advisory committee on informed surgical consent. This committee should have equal members of physicians, patients that have been harmed like myself, and members of the FDA and other governing bodies. All surgeons should use an independent, engaging, and interacting web-based informed consent by 2020 and review and update it annually.
FDA, you failed surgeons and patients, and this is your opportunity to make it right. Do your job.
Thank you for your time.
[Open public comment given by breast implant recipient Lisa Rohland, at the General and Plastic Surgery Devices Panel, FDA White Oak Campus, Building #31, Great Room, on March 26, 2019. The title of this article does not constitute part of the speaker’s presentation to the FDA Panel, and any hyperlinks within the text or text appearing in brackets were added for clarity or ease of use by editors.]