Mesa, Arizona
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 Illness
and Information Facebook page. In just eight months, I’ve helped over five
hundred sick women connect with each other and find qualified explant
surgeons.
Informed consent is the most important conversation 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 is
written at a collegiate level. Reading this thirteen-page form took me 1 hour
and 48 minutes.
At this meeting in 2002, a video-based informed consent process 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 or the implant
handbook that I never received. I remember my surgeon saying, “These
risks really NEVER happen.” Then he had me sign and initial a single page
consent form acknowledging I “understood” ALL of 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 they
deserved.
I’ve listened to the testimony of multiple women within the last year that
were part of implant studies. I continued to hear that as soon as adverse
events were reported, patients would receive a letter that they had suddenly been dropped from their study, or were just never contacted again. Several
women were removed just two years into their ten-year study.
We’ve recently learned that women reporting adverse events directly to the
FDA had their data placed into a repository. As a result, all that
information has still not been made public- not to patients, not to doctors,
and not to the media. Transparency regarding adverse events and the
chemicals contained in these implants is essential for women to make
informed decisions.
Patients need to be told about all potential risks to allow for autonomy in
the informed consent process. Otherwise, it is the surgeon and the
manufacturer making the decision on behalf of the patient, regardless of
how small that risk may be.
I would like to help you form an Advisory Committee on informed surgical
consent. This committee should have equal members of physicians,
patients who have been harmed like myself, and members of the FDA, and
other governing bodies. All surgeons should use an independent, engaging
and interactive, web based informed consent by 2020 and review and
update it annually. FDA, you have failed surgeons and patients and this is
your opportunity to make it right. Do your job.
Lisa testified at the FDA Advisory Committee Meeting on breast implants in March 2019.