Few Patients Undergo Recommended MRI Screening After Silicone Implant Breast Surgery

Only 6% of women with silicone breast implants followed the previous FDA recommendation for regular magnetic resonance imaging (MRI) screening, suggests a study in Plastic and Reconstructive Surgery, the official medical journal of the American Society of Plastic Surgeons (ASPS)

Despite discussion and information provided at the time of their breast implant procedure, most patients said they were unaware that MRI scans were recommended to detect asymptomatic implant rupture, according to the new research by Libby R. Copeland-Halperin, MD, of Brigham and Women’s Hospital, Boston, and colleagues. They write, “Low adherence suggests that without repeated reinforcement, the importance of this recommendation may not be apparent to patients several years following surgery.”

Silicone breast implants are widely used for breast reconstruction as well as cosmetic breast augmentation. Among the possible complications is implant rupture—one of the leading reasons for implant removal, with special concern about silicone leakage. Although implant rupture can cause various symptoms, up to half of women with ruptured implants have no symptoms.

Starting in 2006, FDA recommended routine MRI scans for detection of implant rupture, starting 3 years after surgery and every 2 years thereafter. However, clinical experience suggested that many patients did not follow this recommendation. “Unfortunately, because routine, asymptomatic follow-up visits several years postoperatively may not be covered by insurance policies and cosmetic procedures/follow-up are not covered by insurance, many patients may not return for follow-up around the time MRI would be due,” the researchers write.

Dr. Copeland-Halperin and colleagues performed a telephone survey with patients who had undergone silicone breast implant surgery between 2011 and 2016. The women were asked whether they were aware of the FDA screening recommendation, whether and why they had follow-up MRI scans, and any barriers to screening.

Of 130 women contacted, 109 agreed to participate in the survey. Of these, 86 had silicone implants placed for breast reconstruction and 23 for breast augmentation.

Overall, 15.6% of women had undergone MRI at any time after implant placement. However, only 5.9% had MRI scans within the FDA-recommended timeframe. Adherence to MRI screening was no different for women who underwent reconstructive versus cosmetic implant placement. Screening rates were also similar by insurance status or income level.

In contrast, nearly half of the women (48.6%) had undergone ultrasound or mammography for various reasons—most commonly for breast cancer screening or breast pain. That included nearly three-fourths of women (73.3%) who later underwent MRI. The researchers note that ultrasound and mammography are less costly than MRI, but less effective in detecting implant rupture.

Of 17 women who had an MRI scan at any time after implant placement, just one cited routine implant surveillance as a reason for scanning. None of the MRI scans detected any abnormality with the implant. Three of the women who did not undergo MRI were aware of the screening recommendation. They didn’t undergo testing because they had no concerns about their implants or they “didn’t like MRIs.”

“Whether MRI is the optimal imaging modality, uncertainty about its clinical utility, and concerns about the economic cost of the FDA recommendation are topics of debate, and many plastic surgeons do not agree with the recommendation,” the researchers write.

In 2020, the FDA changed its surveillance recommendations to include ultrasound or MRI beginning 5 to 6 years after silicone implant placement and every 2 to 3 years thereafter. “Because our study was initiated before this change, we examined patient awareness of and adherence to the prior recommendations,” Dr. Copeland-Halperin comments. “It is possible that the new guidelines may improve patient adherence, though further studies are needed to determine this. Similarly, the perception of the guidelines among plastic surgeons may also have changed with the updated recommendations.”

New Allergan Aesthetics Report Highlights Aesthetics Trends to Come

Consumer interest in medical aesthetics continues to rise, with the number of dermal filler treatments worldwide growing by almost two million between 2017 and 2020, according to Allergan Aesthetics’ “The Future of Aesthetics” global trends report.

In addition, the report found that physicians around the world are now catering to an increasingly diverse patient population spanning different ages, races, and genders.

Commissioned by Allergan Aesthetics and independently developed by specialist trend forecasting agency Wunderman Thompson Intelligence, the report aims to help the industry understand the developments driving today’s aesthetics market, and to highlight the key trends that may shape it in the years ahead.

“The Future of Aesthetics global trends report helps us to understand what is driving aesthetics today and what will shape the aesthetics industry of tomorrow,” says Carrie Strom, SVP, AbbVie and President, Global Allergan Aesthetics. “The report builds on our 2019 research—Allergan 360° Aesthetics Report—about evolving global beauty perceptions and priorities and reaffirms our commitment to innovative science and the future growth of the market. The input we received from practitioners and consumers provides a unique view of what tomorrow may hold for aesthetics. It’s an exciting time to be in this industry and we are thankful to our partners who participated in this important study.”

The new report was released at a virtual event for media and industry. Report co-contributor Dr. Jonquille Chantrey, UK, talked delegates through the drivers behind today’s behaviour change: Beauty Empowerment, Untabooing Treatments, Aesthetics-Fluency and a desire to move Back to Nature and then gave an overview of the 10 major trends identified in the report as most likely to impact medical aesthetics practice in the coming five years. This list includes gender-inclusive beauty, diverse individuality, and an increase in men seeking aesthetic treatments.

“This report will enable us to understand the patients of tomorrow and implement practical changes that appeal to them,” says Dr. Chantrey.

The report was validated via interviews with 15 world leading aesthetics practitioners from 13 trend-led countries between May and September 2021. It is informed by research and analysis across consumer and business media, social listening data, and market research from around the globe.

To receive a copy when it goes live in your country or for more information on the trends identified, please visit global.allerganaesthetics.com/.

Study Assesses What Makes Lips Most Attractive

Social media and celebrity icons may be driving increased demand for fuller, “pouty” lips, but a new study in the August issue of Plastic and Reconstructive Surgery found a natural-looking and harmonious appearance of the lips is perceived as most attractive.

Eye-tracking studies show that viewers actually spend more time looking at lips that are rated less attractive—suggesting that more attractive lips don’t mean increased attention, according to the new research by Sebastian Cotofana, MD, PhD, of the Mayo Clinic, Rochester, MN, and colleagues. They write, “Visual attention, based on the results of this study, is not reflective of the beauty in the image assessed; rather the opposite.”

Starting with a stock photo of a young woman, the researchers created a set of digitally altered images representing a range of lip proportions (ratio of the upper lip to lower lip) and volumes. A panel of observers—mainly volunteers with no medical or aesthetic background, along with several plastic surgeons and dermatologists—rated the images for attractiveness. The researchers also used eye-tracking technology to assess what parts of the model’s face the raters were looking at, and how much time they spent looking at each area.

In the subjective assessments, a lip proportion of 1 to 1.6 (upper lip to lower lip) was rated as most attractive: average score of 4.21 out of a possible 5. The 1:1.6 proportion is widely accepted as the “golden ratio” for beautiful lips. By comparison, an image showing a fuller lower lip (1:2 ratio) was perceived as less attractive, with an average rating of 2.16 out of 5.

On assessment of lip volume, an image showing the model’s “non-augmented, natural volume” was rated most attractive: average score 4.56. In contrast, for an image showing the lips enlarged to 130% of their natural volume, the average rating was 1.56. The preference for a more natural-looking appearance “confirms previous investigations and current trends in aesthetic medicine,” Dr. Cotofana and coauthors write.

In the eye-tracking analysis, the raters actually spent less time looking at the lips rated as most attractive: those with a 1:1.6 ratio and 100% lip volume. In contrast, they spent more time looking at the images showing digitally altered lips.

Why would observers devote more attention to the features they found less attractive? It may reflect a potential mismatch between the observed image and the rater’s “internal standard” of beauty. “Visual stimuli that match the internal, socially influenced standard of beauty require less effort to be perceived,” according to Dr. Cotofana. “In contrast, visual stimuli that do not match the internal standard of beauty require more processing time – as reflected by involuntary eye movements as captured by eye tracking.”

Thus the findings question the assumption that viewers will spend more time looking at attractive parts of an image. The researchers add: “Rather, it could be reflective of the cognitive processing of the observers: less attractive content captures the observers attention more quickly, yet needs more time to be processed.”

The findings may have implications for understanding aesthetic trends and behavior - especially in the era of selfies and social media driving requests for cosmetic plastic surgery and noninvasive procedures, including lip enhancement procedures using dermal fillers.

While the findings may seem surprising, they are in line with current trends in aesthetic medicine and surgery – emphasizing a more natural result, without obvious signs that the person has undergone a procedure. “It can be now postulated that a ‘beautiful’ and ‘aesthetically pleasing’ outcome would fulfill such desired requirements where the patient is perceived by those around them with less cognitive effort,” Dr. Cotofana and coauthors conclude. “[T]he perceived beauty matches the ‘internal standard’ effortlessly.”

Evolus Seeks Eternal Love in New “Switch Your Tox” Campaign

Evolus, Inc launched a new campaign, “Switch Your Tox and Love Evolus Forever,” aimed at encouraging consumers to try Jeuveau (prabotulinumtoxinA-xvfs). As part of the promotion, participating injectors get discount vouchers totaling $160 for two consecutive treatments for new Jeuveau patients, with the goal of increasing adoption among customers and consumers.

Evolus practices can begin participating in the program through the company’s digital app, and consumers can enroll beginning September 1 at participating locations. In addition to the consumer discount vouchers, Evolus practices that purchase specified quantities of Jeuveau can receive product discounts, exclusive in-office events, and co-branded marketing incentives, including streaming television advertisements and digital ads with a direct call to action to book appointments using a smartphone and QR code.

The Skinny on TikTok Face

“TikTok Face” is the media-given name for all sorts of poses (think shielding your face like you’re evading the paparazzi) and hacks such as taping to reduce wrinkles or contouring with sunscreen so you look better in your photos and in person.

And it’s causing a rise in requests for facial plastic surgery and other cosmetic procedures. The 2021 AAFPRS survey found that 79 percent of facial plastic surgeons said patients were seeking procedures for an improved appearance on video conferencing, compared to only 16 percent the previous year.

“Unlike its predecessors, TikTok makes those static filters fluid, further blurring the lines between fantasy and reality,” says facial plastic surgeon Dr. Corey Maas, President of the American Academy of Facial Plastic and Reconstructive Surgery (AAFPRS), in a news release. “With a single click, jaws and noses can be slimmed, eyes enlarged and reshaped, lips volumized, and so on. TikTok technology has become so advanced, that a makeup filter can smooth pores and add lashes while remaining nearly undetectable to the untrained eye, especially when in movement.”

Getting beauty advice from TikTok for body and facial aesthetics can be harmful, says Jeanine B. Downie, MD, FAAD, Director of Image Dermatology PC in Montclair, NJ. Her popular video series (follow us on Instagram @modaesthetics to watch) and column, Beauty Counter MD, unpacks the risks and benefits of TikTok skincare and beauty trends.

“One of my patients came in right before the 4th of July holiday and told me that she had not been here for over three years because she had silicone placed in her butt and found her doctor on TikTok,” Dr. Downie recalls. “The person was not an actual doctor but was some type of a technician. She wound up in the hospital in a coma for over 30 days. She was septic and nearly died.”

The technician stole more than $20,000 dollars from her bank account too, Dr. Downie says.

“Patients should find their board-certified dermatologists and plastic surgeons from the American Academy of Dermatology, the American Association of Plastic Surgeons (AAPS) or the AAFPRS,” she says. “Patients may have unrealistic expectations and need to educate themselves by going to the real experts.”

Close Up With Caroline Glicksman, MD and Patricia McGuire, MD

Many patients with breast implant illness cite heavy metal toxicity as a potential culprit. To find out what role heavy metals in implant capsules may play in causing symptoms, the Aesthetic Surgery Education and Research Foundation funded a large prospective biospecimen study. The upshot? While heavy metals were detected in implant capsules, they were well below what is considered safe levels of exposure and were the same or less than what was found in the breast tissue of women who never had breast implants. Modern Aesthetics® magazine chatted with study authors Caroline Glicksman, MD, MSJ, a board-certified plastic surgeon in private practice in Sea Girt, NJ, and an assistant clinical professor, Hackensack Meridian School of Medicine, Nutley, NJ, and Patricia McGuire, MD, a board-certified plastic surgeon in St. Louis, MO and a clinical instructor of surgery, Washington University, St Louis, MO, about their findings and what they mean for women with breast implants. The full study is published in the Aesthetic Surgery Journal.

WHY IS THIS TOPIC IMPORTANT?

We performed this study to see if we could find clues as to why some patients with breast implants develop systemic symptoms. Talking to our breast implant illness patients and patient advocates, heavy metal toxicity is often believed to be a cause. It is very prevalent in breast implant illness social media groups and websites. When we reviewed the literature, we could not find any published papers that looked at heavy metals in implant capsules (the scar tissue that normally forms around implants). The breast implant illness patients believe that if any capsule tissue is left behind and contains the concerning metals, their symptoms will not improve. The metals paper is the second published paper from our study, which is the first prospective, blinded study with control groups looking at systemic symptoms in women with implants. We wanted to see if, in fact, there were metals in capsules in levels that could cause symptoms requiring capsule removal.

DESCRIBE THE RESEARCH AND YOUR FINDINGS.

This study is the first prospective, blinded study with control groups looking at women with breast implant illness qualitatively with symptom surveys and quantitatively with biospecimens (blood and implant capsules). We wanted to see if there were measurable differences between the cohorts to help explain symptoms and point to potential causes. We had three study cohorts, women with self-described breast implant illness, women with implants who did not have symptoms they attributed to their implants, and women who never had any implanted medical device undergoing cosmetic mastopexy. We looked at demographics, symptom surveys, patient-reported outcomes measurement information system (PROMIS), a National Institutes of Health-validated measure, before surgery, 3 to 6 weeks, 6 months, and 1-year post operatively. The day of surgery blood was drawn, and the implant capsules were photographed, described, and sent for analysis for 22 heavy metals, next-generation DNA sequencing for bacterial and fungal DNA, and the remaining capsule had microscopic examination. The blood was sent for inflammatory markets, thyroid function, Vitamin D levels, cytokines, and antibodies to bacterial toxins. All specimens were sent to the labs blinded, with no indication of which cohort the specimens as from. Most of the patients in the study had smooth-walled, saline implants. We found the patients symptoms did improve after implant removal, and that improvement was sustained at 6 months. For the metals analysis, we did find metals in the capsules, but in levels well within what is considered safe levels of exposure. Some of the metals were found at higher levels in the breast tissue of the patients who never had a breast implant. Our conclusion was that while there are metals in capsules, they are well within levels that are considered safe for exposure and should not be used as a reason for removing the capsule at the time of explant.

WHAT IS THE NEXT STEP?

The next step is our third paper. This is the analysis of the capsules for bacterial and fungal DNA, the results of the blood work, cytokines, and bacterial toxins to see if there were measurable differences between the cohorts that could be used for diagnosis and point to the direction of further research. Our first published paper showed that symptom improvement was independent of whether the entire capsule or part of the capsule was removed. We have just started another study looking to see if symptom improvement is the same if none of the capsule was removed. We will also be publishing the 1-year data.

Why the pre-owned aesthetic device space IS attractive.

“After analyzing various industries, the decision to focus on the aesthetics device sector came naturally. There are three key components that make a marketplace thrive, and we believe the aesthetics device resale space matches these characteristics perfectly. It’s a hyper-growth market, growing 10 to 15 percent or more a year compounded. Second, it’s cash-based versus most hospital and clinical purchasing. Third, it’s a highly emotional industry.

“Once we identified our marketplace, we focused on enablers. These tools or services allow the consumer to make the leap to the online market. Think of an online marketplace like eBay Motors. An example would be eBay motors, whose enablers are tool extensions such as CARFAX, financing options, and money-back guarantees.

“We built the largest pre-owned processing center in the world. We now have a thousand systems that we own with 10,000 parts, handpieces, and peripherals, and in tandem, we established other platforms such as MedEquipTech.io or MET, a side-by-side Angies/Iber like side for Techs and Trainers.”

MRP is dominant and growing.

“Since Powered by MRP’s founding in 2015, our mission has been to create a fair market for physicians to access biomedical energy-based devices at GPO-level pricing to lower the physician’s overhead cost and generate more access to care for patients as a result.

“Throughout the ongoing Covid-19 pandemic, our services have been a vital element in aiding medical practices globally ensuring the market’s return to its average growth trend by 2023.

“We’ve expanded to include brand new equipment in our portfolio of services and are also branching into general medical and pharma prescribed items. Our ongoing partnership with McKesson has enabled us to have 60,000 SKUs, and we will be adding another 150,000 SKUs within the next few months.”

Online solutions May upend the current sales model.

“For businesses to be successful in the long term, an online marketplace must be consumer-centric. Aesthetic manufacturers tend to be stakeholder and shareholder centric. Our focal point and number one priority is to build ultimate trust. To do so, we developed the Tech Stacks needed to support the consumer in selecting and acquiring the right device for their needs.

“We will witness a vast reduction of field sales reps within the next five years. Tech Stacks will provide peer-to-peer reviews, best pricing options, full transparency services, and warranty costs with broader options and uptimes. We were heading in this direction pre-Covid, but the pandemic dramatically accelerated this trajectory.”

Clinicians Can recoup their equity.

“Manufacturers make the resale market for devices challenging for clinicians. For example, a doctor might determine the device they purchased for roughly $100,000 is not a good fit. They might reach out to a colleague and offer to sell the unit for $70,000. A local sales rep may undercut the pricing and offer the colleague a new system for the same or even less money.

“The selling of a device online or through advertising channels is complicated. Doctors must worry that they now will be in a successor liability stream for the equipment they sell. The seller could conceivably be sued if the buyer has an unfavorable outcome. Traditional resellers or the original manufacturer may buy the device but will charge a re-certification fee, thus paying a minimal price and citing the relatively low resale price of the system.

“Clinicians can easily connect with interested buyers to sell their used system for a highly competitive price with our trusted platform. Both buyer and seller determine the cost of the system. The platform then initiates the sale, examines, calibrates, and certifies the device resulting in a trusted and facilitated transaction. We take a nominal fee for processing the device, and the seller can feel confident that the majority of their available equity has been recouped.”

The market will continue to evolve and expand.

“The aesthetic device market is vastly growing. This pre-owned market accounts for approximately 20 to 30% of overall gross sales. There is new device innovation in aesthetics that includes improvements on existing technologies. We see an increase coming from emerging markets such as Korea and other parts of Asia, where manufacturing costs are more favorable, resulting in downward pressure on the overall cost of these devices.”

The tide is shifting toward consumer-centricity.

“Hundreds of millions of dollars of unused equipment are sitting in offices across the United States. The pre-owned space has a bad reputation, in some cases, justifiably. That’s not to say that there are not some exceptional pre-owned resellers out there.

“Competition opens the industry up to a customer-centric approach. Platforms such as MRP.io will continue to change the landscape giving clinicians back the power. In the next five to ten years, we could see the single largest reduction in healthcare costs, thanks to Tech Stacks being delivered in a way that consumers can make their own decisions without sales representatives influencing the bottom line.”