The lab test would be able to measure silicone metabolites in blood and urine samples to provide a simpler and effective method for detecting implant ruptures.
A pair of scientists and faculty members from University of California Los Angeles are working on a lab test to detect silicone breast implant ruptures.
Kym Faull, a professor of psychiatry and biobehavioral sciences at the Jane and Terry Semel Institute for Neuroscience and Human Behavior at UCLA, and Michael DeLong, MD, an assistant professor-in-residence in plastic and reconstructive surgery at UCLA Health, have been working on a test that can measure silicone metabolites in patient blood and urine samples – a potential revolution in how breast implants are monitored for safety.
It is hoped that the lab test may also help discover if there is a link between leaking implants and a constellation of symptoms that some women report which has become commonly known as breast implant illness.
The Food and Drug Administration recently elevated safety warnings over breast implants after collecting reports from hundreds of thousands of women about a novel cancer and other chronic conditions, like brain fog, joint pain and fatigue.
While regulators have said more research is needed into what’s possibly causing the range of symptoms, the silicone used in implants is seen as a possible culprit.
“There was some preliminary evidence in the medical literature that some of these little silicone molecules in implants may be leaching out,” said DeLong, who was recently appointed to a Food and Drug Administration advisory panel on general and plastic surgery devices.“We thought maybe our test can detect these, and it would be a better way of identifying rupture.”
Currently, the only way to confirm an implant rupture or leak is through surgery to visualize the implant, although MRI studies are non-invasive and can be relatively accurate. While the FDA recommends regular screenings for patients with silicone implants, historically very few patients have followed this recommendation.
In 2019, the FDA convened a special advisory committee to examine breast implant safety. Last fall, the agency added a black box warning on breast implants – its strictest warning level for medical devices or drugs – and required that patients be informed that breast implants have been linked to an immune system cancer known as Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL) and that many women with breast implants have reported otherwise unexplained symptoms.
As breast implant safety gained growing attention, DeLong sought Faull’s help to develop a lab test to detect silicone metabolites, hoping it would be cheaper, more accurate and less involved than the MRI procedure currently in use.
This work is being conducted at the Semel Institute’s Pasarow Mass Spectrometry Laboratory overseen by Faull. It could potentially be applied clinically for identifying breast implant ruptures and help provide sought-after answers about breast implant safety.
Faull and DeLong believe their test is one of very few – if not the only – research efforts aimed at identifying breast implant leaks without the use of imaging technology. They continue to refine the test but said they believe they were able to identify silicone molecules in an earlier version.
Faull and Dr. DeLong have also been working with a local plastic surgeon in Beverly Hills, Kevin Brenner, MD, FACS, to study patients experiencing symptoms related to breast implant illness, and they are hoping to recruit more patients.