Patients with silicone breast implants are being faulted for not following FDA MRI guidelines which 85 percent of them say their surgeon never told them about.
From 2006 to 2020, the FDA recommended that women with silicone breast implants (SBIs) undergo MRI scans three years after getting the implants, and every two years thereafter.
A study, published in the August edition of Plastic and Reconstructive Surgery, set out to determine how many women followed these recommendations, as well as to identify any barriers to their adherence.
The headlining takeaway of this study, according to its publisher, and the American Society of Plastic Surgeons, is that, “Few Patients Undergo Recommended MRI Screening After Silicone Implant Breast Surgery.”
“Only six percent of women with silicone breast implants followed the previous U.S. Food and Drug Administration (FDA) recommendation for regular magnetic resonance imaging (MRI) screening…Few Patients Undergo Recommended MRI Screening After Silicone Implant Breast Surgery, American Society of Plastic Surgeons, Wednesday, July 27, 2022
According to the study, 5.5 or 5.9 percent of women with silicone breast implants followed the FDA’s MRI recommendations.
That fact isn’t in dispute.
Its significance is.
At its core, the study—Magnetic Resonance Imaging Screening after Silicone Implant Breast Surgery: Patient Survey of Adherence to U.S. Food and Drug Administration Recommendations—is simply the tabulated results and attendant discussion of a survey conducted by phone on patients with silicone breast implants.
(Women 18-years old or older who received silicone breast implants between 2011 and 2016, whether for cosmetic breast augmentation (23) or for breast reconstruction (86).)
One hundred thirty (130) such patients were contacted and 109 of them consented to being surveyed.
Of the 109 patients surveyed, 6 received an MRI in accordance with the FDA’s recommendations. (5.5%)
Of the 109 patients surveyed, 92 were unaware of the FDA’s MRI recommendations. (84.4%)
More specifically, when asked “Did your doctor ever tell you to have an MRI after your breast implants were placed?,” 92 out of 109 women surveyed said “No.” [The study’s lead author disputes this, as detailed below.]
Yet a staffer at the journal’s publisher and the largest society of plastic surgeons in America has opted to make the former statistic the slant and focus of their statements announcing the study.
This slant has made its way into at least one consumer publication.
“Unsurprisingly, only about 6% of women with silicone implants actually followed the old MRI guidance, according to new research….”“Are Breast Implants Safe? What the Experts Know Now About Risks, Complications, and Side Effects,” RealSelf.com, August 17, 2022
Surgical Times reached out to the study’s lead author, Dr. Libby R. Copeland-Halperin, M.D., in late August.
She initially assured the Times it was misinterpreting the study and that it would be inaccurate to make this statement:
“It appears that a key common denominator is that most patients (92 of 109 is 84.4%) were simply never told by their plastic surgeons that they needed to have follow up MRIs.”
The manuscript does say “92 patients were unaware of the recommendation, despite this having been discussed during perioperative clinic visits and summarized in supplemental information pamphlets.”
It does not focus on the significance of this, nor provide a percentage for the number of patients this represents.
A review of the study and the phone survey script on which it is based appears to reveal that the datum could only have been determined if survey participants answered “no” to one of the survey’s three primary questions:
“Did your doctor ever tell you to have an MRI after your breast implants were placed?”
Dr. Copeland-Halperin says, “No. This is an inaccurate statement. As we describe in the paper, the recommendation for surveillance imaging was discussed routinely with all patients during their perioperative clinic visits and summarized in supplemental information pamphlets.”
Upon further questioning how it was—as stated in the manuscript—deduced that 92 patients were unaware of the FDA’s MRI recommendations, lead author Dr. Copeland-Halperin replied:
“As stated in the manuscript, this was determined based on the patients’ responses to the survey, asking if they recalled the discussion with their doctor regarding the FDA recommendation and their reasons for not having imaging.” (Emphasis added.)
The question asked of patients was, “Did your doctor ever tell you to have an MRI after your breast implants were placed?” and it is the only question that appears to elicit this information.
To which 92 patients answers would have to have said “No.”
(The other two primary questions on the script are, “Since your breast implant surgery in [year], have you had an MRI of the breast for any reason?,” and “What is the reason you didn’t have the MRI?”)
To be sure, the Times asked: “Did 92 out of 109 patients surveyed answer ‘No’ to that question?”
Lead author Dr. Copeland-Halperin answered:
“92 patients were unaware of the recommendation for surveillance imaging despite this being routinely discussed with patients during their perioperative clinic visits and summarized in supplemental information pamphlets.”
This again not only left our inquiry unanswered, but seemingly reinforces a derogatory aspect we had also inquired about: That the fault or onus was being placed on patients—who were themselves unaware of needing an MRI in the first place.
Just as Dr. Copeland-Halperin stated in her reply—“…despite this being routinely discussed with patients…”—the manuscript and two news releases based on it likewise point out that patients fail to get MRIs “despite discussion” about the need to do so by their surgeons.
Thus we asked: “How do we know it was discussed during perioperative visits if 92 patients were unaware of the need for routine MRI screening?”
Lead author Dr. Copeland-Halperin replied:
“The standard practice at the institution where this study was conducted is to routinely discuss the recommendation for surveillance imaging with all patients during their perioperative clinic visits and to provide this information in supplemental information pamphlets.”
A full 92 out of 109 patients surveyed told the study’s authors they were “unaware of the [MRI] recommendation.”
But since telling silicone breast implant patients to get MRIs was allegedly “standard practice at the institution where this study was conducted,” well, they had to have known.
The manuscript further includes five detailed tables displaying more than 35 unique criteria and demographics about the surveyees, most of which are given in both numerical and percentile form.
But the single largest common denominator doesn’t appear on these tables, either.
It’s that 84.4% of women surveyed said they were never told by the surgeon who gave them silicone breast implants to get an MRI, despite FDA recommendations to do so.
Note: In September 2020, the FDA’s breast implant screening recommendations changed: “Even if you have no symptoms, you should have your first ultrasound or MRI at 5-6 years after your initial implant surgery and then every 2-3 years thereafter. If you have symptoms at any time or uncertain ultrasound results for breast implant rupture, an MRI is recommended.” This study evaluated adherence to the FDA’s earlier recommendations.
The study can be read in full and for free, here.
The telephone survey used can be read in full, here.