A new study addresses misconceptions and unknowns about the condition.
Breast implant illness (BII) has been a hot topic in plastic surgery for several years. Patients experiencing a range of symptoms, from joint pain to chronic fatigue, attribute their conditions to their implants. However, until now, there has been scarce scientific evidence to support this claim. A recently published study funded by the Aesthetic Surgery Education and Research Foundation (ASERF) sheds new light on BII-related symptoms.
The principal investigators of the “Systemic Symptoms in Women — Biospecimen Analysis Study,” Wall Township, NJ plastic surgeon Caroline Glicksman, MD, who is also the president of the Aesthetic Society Education and Research Foundation (ASERF), and Saint Louis, MO plastic surgeon Patricia McGuire, MD spoke to us about the importance of their findings.
“Our study, funded by a ASERF grant, is the first prospective, blinded study to compare women with self-described breast implant illness to two control groups,” explains Dr. McGuire. “One of our goals was to prospectively follow symptom improvement after implant removal. Most studies are retrospective, meaning they aren’t done until after surgery, which can be subject to recall bias.”
Implant Removal = Sustained Improvement of Symptoms
The study leads used symptom surveys, outcome measures and lab analysis of blood and capsule tissue to compare patients. This allowed them to find any consistent, measurable differences that could point to a cause of symptoms in these patients.
“We found that the BII cohort had many more symptoms and more severe symptoms than our control groups, which consisted of women with implants who didn’t have symptoms they attribute to their implants and patients undergoing cosmetic mastopexy who had never had breast implants,” said Dr. McGuire.
No “Smoking Gun”
“We looked for different markers in the blood,” explains Nashville plastic surgeon Melinda Haws, MD, who served as a clinical investigator. “The capsules were sent to pathology to detect bacteria, fungus, and any other type of culture. We also tested for heavy metals as many BII advocates believe heavy metals in breast implants are the cause. What we found was that there wasn’t a smoking gun. There wasn’t one thing we could point to as the cause. We also found the BII group had a dramatic drop in symptoms once the implants were removed.”
“En Bloc” Removals Are Not Necessary
Another significant finding related to which implant removal technique is most effective. A typical capsulectomy involves creating an incision in the capsule and removing the implant separately from the scar tissue. An “en bloc” capsulectomy removes the implant and the scar tissue as one without cutting into or opening the capsule. There has been a lot of misinformation about who needs an “en bloc” and an increase in “explant experts” recommending this approach.
However, the findings suggest that an “en bloc” is not needed to alleviate symptoms. “There is no such thing as an ‘explantation expert,’” notes Dr. Glicksman. “Board-certified plastic surgeons are trained to remove breast implants. Patients should avoid surgeons who are not practicing evidence-based medicine.”
A New Hope
These results provide hope for patients experiencing symptoms related to breast implants. They confirm that breast implant removal can improve symptoms. As the data shows, the terminology used is crucial to avoid misleading patients. The investigators suggest using the term “Systemic Symptoms Associated with Breast Implants (SSBI)” instead of BII.
“There is also a published prospective study showing that without other indications, these patients may have symptom improvement with no capsulectomy,” adds Dr. McGuire. “That should be good news for patients. They are likely to have symptom improvement after implant removal with a procedure that is less invasive, less expensive, and may have a lower risk of complications.”
La Jolla, CA plastic surgeon Robert Singer, MD notes that while BII symptoms should not be ignored, overall the majority of breast augmentation patients have had a favorable experience. “Numerous studies have shown that well over 90 percent of patients who have implants are glad they did it,” he explains. “Over two-thirds of those having their implants removed for one reason or another opt to put in new implants.”
