Good morning. I’m Dr. Marisa Lawrence, and I have no financial disclosures.
I’m a board-certified plastic surgeon who’s used breast implants in patient care for the past 25 years.
I’m a member of both the Aesthetic Society and the ASPS.
In the past 2 years, I’ve evaluated over 200 women for systemic symptoms they believe to be related to their breast implants.
My slides? My slides are not—okay. [Slides not being displayed.]
Although there’s not sufficient evidence to show an association between breast implants and connective tissue disorders at this time, these women are requesting implant removal for what is referred to as breast implant illness.
Currently, there’s no diagnostic testing for this illness.
To better understand their concerns, I began to collect data from my patients as I spoke with them, reviewed their medical histories, and performed their surgeries. I created pre- and postoperative questionnaires to track symptoms and medical eval and conditions. My study is ongoing with patients being added on a daily basis.
Although far from complete, I wanted to share some of the information I have obtained so far. The study currently includes 100 women ages 28 to 77 with implants placed between 1983 and 2018.
Slightly more than half of the patients began to experience symptoms within 1 year of implant placement. An additional 34% began having symptoms between 1 and 5 years of placement.
Most patients had no abnormality in serologic or other diagnostic studies. However, 13 of the 100 patients did develop a confirmed autoimmune disease after their implants were placed.
Breast implant illness does not appear to be isolated to one type of implant. Patients reported symptoms with textured and smooth surfaces as well as silicone and saline filled.
Data collection is still ongoing, but based on 38 post-explantation questionnaires completed 6 to 12 weeks after surgery, 31 patients had partial resolution of their symptoms, 5 patients experienced no change, and 2 patients had complete symptom resolution.
Slide 9 was supposed to show the patient-reported symptoms that demonstrated the most improvement following implant removal. There were five of them.
As a patient advocate, I want to provide all of my patients with accurate and up-todate data while discussing treatment options.
My study, while small and not yet complete, suggests that there is no direct relationship between breast implant illness and implant type.
Some patients have improvement in symptoms after implant removal, but explantation does not guarantee resolution of illness.
Long-term follow-up, genetic testing, DNA sequencing to identify the capsular microbiome, pathologic and histologic examination of capsule tissue, and toxicology evaluation of implant-based substances are all needed to better evaluate our patients.
Thank you for your time.
[Open public comment given by board-certified plastic surgeon Dr. Marisa Lawrence, 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.]