Abstract
Introduction
Despite a lack of data demonstrating causation, there is growing concern over breast implants and systemic illness. This study examines the impact of rising public interest in breast implant illness (BII) and its implications on breast implant removals (BIR).
Methods
A Google Trends (GT) analysis of each year between 2010 and 2022 was performed globally, and then separately for the United States alone (US), using the search terms “capsular contracture,” “breast implant illness,” and “breast implant(s) removal”. Linear regression was performed to determine significant correlations. Data on BII-related Facebook advocacy groups, relevant pop culture events, numbers of BIR surgeries, and number of BII-related publications were collected and analyzed alongside GT data to determine relevance.
Results
For global GT, there was a significant relationship between “breast implant illness” and “breast implant(s) removal” in 2016 (R2=0.62, β =0.33, p<0.01), 2020 (R2=0.53, β =0.23, p=0.01), and 2022 (R2=0.60, β =0.44, p=0.01). In the US, 2016 (R2=0.53, β =1.75, p=0.01) 2018 (R2=0.61, β =1.93, p<0.01) and 2020 (R2=0.72, β=0.91, p<0.01) were significant. In 2020, “capsular contracture” and “breast implant(s) removal” was significant in the US (R2=0.58, β=0.4, p=0.01). In 2016, Facebook was the platform for the largest BII advocacy group and in 2020 YouTube was the platform for the first BII documentary and TEDx talk. From 2010 to 2020, PubMed publications containing “ASIA” and “BII” increased 24-fold and ASPS reports on BIR rose 70%.
Conclusion
This study suggests that BII is a topic of global concern and has implications on both academic medicine and clinical practice.
Level of Evidence V
This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266.
Keywords: Breast implant illness, BII, Breast implant removal, Social media
Introduction
Breast implants have been linked to otherwise inexplicable systemic symptoms since their introduction in 1963 [1–5]. Siliconosis, human adjuvant disease (HAD), and autoimmune/inflammatory syndrome induced by adjuvants (ASIA) were the first recorded complications of silicone implant-based breast augmentation that resembled several known auto-immune disorders [2–4, 6–8]. At the American College of Rheumatology meeting in 1992, 72 cases of connective tissue disease (CTD) were reported as a result of soft tissue injections or silicone prostheses [7]. Similarly, the 1992 George Washington University Medical Center Symposium concluded that silicone implants are not inert, can cause systemic tissue damage, and that systemic symptoms were resolved after implant removal [6]. Since that symposium, the resolution of symptoms following breast implant removal (BIR) has been documented within the medical literature [9, 10].
After numerous case reports [2, 3, 6, 7, 11], the Food and Drug Administration (FDA) removed silicone breast implants from the public market in 1997, and only reintroduced them in 2006 after the Institute of Medicine of the National Academy of Sciences found insufficient evidence to support the immunogenicity of silicone [4, 11–13]. From 2008 through 2020, the FDA released 8547 medical device reports regarding BII symptoms, and in 2019, new breast implant risk communication methods were introduced [14–17]. The current list of symptoms from these reports displays an overlap with a 1994 study of most frequently reported symptoms from breast implants [6, 18]. While there was no consensus on the correct terminology for these symptoms in medical literature, the rapid growth and popularity of “breast implant illness” (BII) on social media contributed to the widespread adoption of this term over the others [10, 13, 19].
Analysis of social media content and search engine trends offer rich, real-time information on public interest. Facebook (Meta Platforms, Inc., Menlo Park, California) is one of the most notable social media websites, accounting for 71.7% of all social media users worldwide [20]. Google Trends is an open-access platform that offers analysis of data of relative search traffic on the Google search engine (Alphabet Inc., Mountain View, California) across time and across locations. Google presently comprises 92.4% of the worldwide search engine market, providing a reliable estimate of general public interest in BII and BIR over time [21]. While not always medically accurate, these platforms provide a means for understanding the larger concerns and sentiments of the general public.
As the interest in BII continues to expand within the digital and medical community, it is imperative for clinicians to understand its relevance and impact on clinical practice [4, 9, 10, 19, 22]. In light of this growing concern, this paper aims to investigate the public perception of BII through social media and search engine platforms, and to explore the impact of BII on clinical practice within the plastic surgery community.
Methods
Pop Culture
Data on Facebook advocacy groups on BII were collected and analyzed in September of 2022. Inclusion factors for Facebook groups were if they had the terms “breast implant illness” in the group name, and if they had more than 300 members. Exclusion factors were if any group was not based in the United States (US), or if the main focus was not BII. Data collected from Facebook included the group’s year of creation, the total number of members on the date of data extraction (September, 2022), whether the group was public or private, the number of posts made in the month prior (August, 2022), the presence of any sites listed in the description, and the hashtags for public groups. Dates of celebrity commentary and events in pop culture that addressed BII’s medical acceptance and were compared.
Google Trends
GT analysis was performed with the terms “breast implant illness,” “capsular contracture,” and “breast implant(s) removal” for the period from January 2010 to September 2022. It is important to note that the database normalizes search terms to 100% scale to reduce data redundancy, improve data integrity, and appear consistent over time [23]. Capsular contracture (CC) was chosen as a means of control as CC is a common adverse effect of breast implants that may require removal [24]. Additionally, the specificity of terms was considered, and as a result, terms like “explant,” “bii,” and “implant removal” were deemed to be too general for the paper’s selection. A linear regression analysis was performed for each year to assess the correlation between BII and CC search frequencies to the search frequency of BIR. The confidence level was set to 95%. R2 less than 0.5 or negative β values were not deemed as significant positive associations.
Medical/Clinical Practice
PubMed literature search was conducted using the terms “breast implant illness”, “human adjuvant disease”, “siliconosis”, and “autoimmune/inflammatory syndrome induced by adjuvants” to retrieve all related published manuscripts. The search was limited to articles written in the English language and published between 2010 and 2022. In addition, the American Society of Plastic Surgeons (ASPS) annual reports from 2010 to 2020 were collected for BIR and breast augmentation [25]. The total case volumes for BIR were compared against the GT for “breast implant illness”.
Due to the public availability of the data and the lack of patient information included, no IRB approval was needed for completion of this study. All data was exported and tabulated from their original sites to Microsoft Excel (Microsoft Corporation, Redmond, Washington) for data handling and analysis.
Results
Pop Culture
Facebook group data yielded 31 BII advocacy groups that met inclusion criteria (Table 1). In 2016, 6 new advocacy groups were launched, including “Breast implant illness and healing by Nicole” that had 170,607 members as of September 2022 (including public figures such as Crystal Hefner, Karen Monetti, Ashley Dale Grant, and Leigh Wood). In 2019, 10 new advocacy groups emerged, the same year that Michelle Visage, a public figure, went public about her BII story, influencing Paramount Pictures to later release a documentary, “Explant”, on her story in December 2021. In 2020 and 2022, BII appeared in a YouTube documentary and two TEDx talks hosted in Idaho and Oklahoma. In 2021, Robyn Towt and Terri Diaz were vocal advocates in the March 2019 FDA hearing for General and Plastic Surgery Devices Panel, urging safety reform and acknowledgment of BII [26–28]. This preceded the 2021 FDA breast implant final guidance for breast implants and an Arizona Senate Bill on breast implant informed consent that was passed in 2022 (Fig. 5, Table 2) [15, 16, 29].
Table 1.
Year | Number of groups | Total members (taken on September 2022) |
---|---|---|
| ||
2014 | 2 | 4884 |
2015 | 1 | 8240 |
2016 | 6 | 184539 |
2017 | 5 | 8321 |
2018 | 3 | 14000 |
2019 | 10 | 58827 |
2020 | 1 | 593 |
2021 | 2 | 871 |
2022 | 1 | 1900 |
Table 2.
Year | Public advocate | Aesthetic breast implant | Reconstruction breast implant (after cancer) | Reported symptoms | In FB group by Nicole | Symptoms resolution/improvement after breast explant | Media platform |
---|---|---|---|---|---|---|---|
| |||||||
2015 | Yolanda Hadid | Y | N | Exacerbation of chronic Lyme disease. | Unknown | Y | Blog, TV show, and Memoir |
2016 | Nicole Daruda | N | Y | Anxiety, swelling, recurring infections, GI problems, jumbled thinking, new food allergies, two autoimmune diagnosis including hypothyroidism. | N/A | Y | |
Crystal Hefner | Y | N | New food and beverage intolerance, unexplained back pain, constant neck and shoulder pain, cognitive dysfunction (brain fog, memory loss), stunted hair growth, incapacitating fatigue, burning bladder pain, low immunity, recurrent infections, and issues with her thyroid and adrenals. | Y | Y | ||
2018 | Karen Monetti | Y | N | Celiac disease, dairy allergy, adrenal dysfunction, severe hormone imbalance, skin issues (hyperpigmentation of her face, rashes), weight gain, four UTIs in a single year, multiple infections, and allergies to most vegetables. | Y | Y | Magazine |
Ashley Dale Grant | Y | N | Hypothyroidism, rashes, muscle weakness, and odd pains. | Y | Y | Magazine | |
2019 | Michelle Visage | Y | N | Hypothyroidism, heart palpitations, hair loss, and chronic brain fog. | unknown | Y | Magazine and paramount pictures plus |
2020 | Leigh Wood | Y | N | Stomach issues, hot sweats, premature menopause, vertigo, dizziness, anxiety, depression, fatigue, hypothyroidism, psoriasis, rheumatoid arthritis, allergic reactions (skin and drug), IBS, high inflammatory markers, felt like she was dying, sore joints, and premature ovarian failure. | Y | Y | Youtube |
Ashley Tisdale | Y | N | New food sensitivities and “gut issues” | Unknown | Y | ||
Lacey Marie | Y | N | Headache, fatigue, rash, rapid weight loss, myalgias, joint pain, insomnia, hair loss, food intolerances, inability to walk on her own, and a total hysterectomy at age 31. | Y | Y | TEDx | |
2021 | Robyn Towt | N | Y | Chronic migraines, rashes, extreme fatigue, debilitating insomnia, burning pain, heart palpitations, hair loss, difficulty breathing, difficulty swallowing and muscle pain. | unknown | Y | Global patient advocacy coalition founder |
Terri Diaz | Y | N | Food allergies/ intolerance, debilitating pain and fatigue, daily migraines, and dizzy spells. “I had over 32 symptoms, and 10 diagnosed auto-immune illnesses.” | Unknown | Y | Global patient advocacy coalition founder | |
2022 | Tamara Judge | Y | N | Thyroid issues, swollen joints, fatigue, and bladder, sinus, and gut inflammation. | Unknown | Y | TV show |
Danica Patrick | Y | N | Dry hair that grew more slowly and began to fall out, weight gain, sudden fatigue, GI issues, and hormone disruption (including low sex hormones). | Unknown | Y | Magazine | |
Dr. Laura Miles | N | Y | Rash, did not feel well, poor thyroid regulation. | Unknown | Y | TEDx |
GI Gastrointestinal, IBS Irritable bowel syndrome, UTI Urinary tract infection
Google Trends
For global GT inquires, there was a significant relationship between “breast implant illness” and “breast implant removal” in 2016 (R2=0.62, β =0.33, p<0.01), 2020 (R2=0.53, β =0.23, p=0.01), and 2022 (R2=0.60, β =0.44, p=0.01) (Table 3, Fig. 1). In the US, 2016 (R2=0.53, β =1.75, p=0.01), 2018 (R2=0.61, β =1.93, p<0.01), and 2020 (R2=0.72, β=0.91, p<0.01) were significant. In 2020, there was a significant association between “capsular contracture” and “breast implant removal” in the US (R2=0.58, β=0.4, p=0.01). No other years revealed a significant correlation.
Table 3.
“Breast implant illness” and “breast implant(s) removal” | |||||||
---|---|---|---|---|---|---|---|
| |||||||
WORLDWIDE | USA | ||||||
|
|
||||||
Year | R 2 | Beta | P-value | Year | R 2 | Beta | P-value |
| |||||||
2010 | 0.00 | 0.00 | 1.00 | 2010 | 0.12 | 0.04 | 0.31 |
2011 | 0.00 | 0.01 | 0.89 | 2011 | 0.38 | 0.20 | 0.04 |
2012 | 0.01 | 0.02 | 0.74 | 2012 | 0.39 | −0.21 | 0.04 |
2013 | 0.07 | 0.03 | 0.43 | 2013 | 0.00 | 0.00 | 0.97 |
2014 | 0.04 | −0.04 | 0.56 | 2014 | 0.02 | −0.03 | 0.67 |
2015 | 0.02 | 0.02 | 0.65 | 2015 | 0.14 | −0.13 | 0.26 |
2016 | 0.62 | 0.33 | 0.00 | 2016 | 0.53 | 1.75 | 0.01 |
2017 | 0.03 | −0.02 | 0.63 | 2017 | 0.05 | −0.07 | 0.51 |
2018 | 0.32 | 0.33 | 0.07 | 2018 | 0.61 | 1.93 | 0.00 |
2019 | 0.00 | 0.02 | 0.91 | 2019 | 0.11 | 0.47 | 0.31 |
2020 | 0.53 | 0.23 | 0.01 | 2020 | 0.72 | 0.91 | 0.00 |
2021 | 0.03 | 0.10 | 0.64 | 2021 | 0.27 | 1.24 | 0.10 |
2022 | 0.60 | 0.45 | 0.01 | 2022 | 0.00 | −0.05 | 0.96 |
| |||||||
“Capsular contracture” and “breast implant(s) removal” | |||||||
| |||||||
WORLDWIDE | USA | ||||||
|
|
||||||
Year | R 2 | Beta | P-value | Year | R 2 | Beta | P-value |
| |||||||
2010 | 0.02 | −0.03 | 0.67 | 2010 | 0.01 | −0.05 | 0.75 |
2011 | 0.07 | −0.04 | 0.43 | 2011 | 0.21 | −0.25 | 0.16 |
2012 | 0.02 | 0.05 | 0.65 | 2012 | 0.01 | 0.13 | 0.79 |
2013 | 0.05 | 0.07 | 0.50 | 2013 | 0.01 | −0.07 | 0.76 |
2014 | 0.00 | −0.01 | 0.88 | 2014 | 0.11 | 0.25 | 0.32 |
2015 | 0.04 | 0.04 | 0.54 | 2015 | 0.05 | 0.18 | 0.52 |
2016 | 0.13 | 0.08 | 0.27 | 2016 | 0.09 | 0.43 | 0.38 |
2017 | 0.15 | −0.09 | 0.23 | 2017 | 0.26 | 0.25 | 0.11 |
2018 | 0.01 | −0.02 | 0.77 | 2018 | 0.00 | 0.05 | 0.85 |
2019 | 0.22 | 0.10 | 0.15 | 2019 | 0.12 | 0.28 | 0.28 |
2020 | 0.42 | 0.11 | 0.03 | 2020 | 0.58 | 0.40 | 0.01 |
2021 | 0.28 | 0.15 | 0.09 | 2021 | 0.17 | 0.29 | 0.21 |
2022 | 0.64 | −0.21 | 0.01 | 2022 | 0.01 | −0.07 | 0.84 |
Medical/Clinical Practice
The PubMed search yielded a total of 55 publications using the phrase HAD, 34 for siliconosis, 128 for ASIA, and 221 for BII. BII first appeared in 1979 and had the highest number publications (49) in September 2022. The number of publications containing the phrase HAD or siliconosis did not increase with time, whereas the phrase ASIA or BII had a 24-fold increase in publications from 2010–2022 (Fig. 2).
Between 2010 and 2020 there was a total number of 293,384 BIR operations, and a 70% increase in BIR within those years. The most BIR reports were filed in 2022 (36,733), with the greatest yearly growth (15%) in BIRs between 2015 and 2016, as well as between 2018 and 2019 (Fig. 3). Region 5 had the highest surgical demand for BIR in 2020 (13,969/66,517 breast augmentations), compared to all other regions (mean: 5,600/31,639 breast augmentations). Region 5 includes: Arizona, Colorado, Idaho, Nevada, New Mexico, Utah, Wisconsin, Arkansas, California, Hawaii, Oregon, and Washington (Fig. 4).
Discussion
Significant celebrity advocates have spoken publicly about their BII experience since 2015, with substantial overlap in medical mandates on breast implant safety in 2020 and 2022. (Table 2, Fig. 5). In 2020 FDA updated its final guidance for breast implants which included labeling recommendations for implant manufactures, a thorough patient decision checklist to enhance patient consent, new screening recommendations for ruptures, and a patient device card. In 2022, the FDA released patient medical device reports on BII, acknowledging its existence, and Arizona enacted Senate Bill 1001, which emphasizes an up-to-date informed consent form preceding breast implant augmentation that identifies suspected BII risks [14–17, 29]. The most popular Facebook group “breast implant illness and healing by Nicole” was a common source of information for many public figures to first learn about BII [9]. Following this group, over 30 new BII advocacy groups emerged on Facebook since 2016 (Table 1). BII publicity was spread across multiple media platforms including magazines (People, Healthline, CTVNews), autobiographies, film (YouTube, TEDx, Paramount Pictures Plus), and Instagram (Table 2) [30–39]. A notable impact was made by two advocates, Robyn Towt and Terri Diaz, who publicly disclosed their BII story in 2019, founded their own advocacy group coalition in 2021, and eventually persuaded the state of Arizona to address breast implant safety in a 2022 Senate Bill [27, 28].
In 2016, 2018, 2020, and 2022, global GT for BII and “breast implant(s) removal” were positively associated (Fig. 1a), as were GT in the US for 2016 and 2020 (Fig. 1b). Although CC had a significant positive correlation with “breast implant(s) removal” in 2022 (Fig. 1d), BII had a stronger positive correlation with “breast implant(s) removal” that same year. The years with positive search term correlations seems to parallel significant events in BII’s internet presence. In 2016, six new BII Facebook advocacy groups emerged, and two public figures openly spoke about BIR for systemic symptoms experienced with the implants (Tables 2 and 4) [30, 31]. Then BII appeared in films in 2020, 2021, and 2022 with the publication of its first YouTube documentary, big production documentary carried out by Paramount Pictures, and two TEDx talks [31, 35, 37, 40]. The newest documentary from Paramount Pictures “Explant” was released on December of 2021 (Fig. 5), which may have influenced a high association of global GT for BII and BIR the following year.
Table 4.
General symptoms | Immune system and infections | Hematology and oncology | Gastrointestinal | Musculoskeletal | Cardiovascular system | Respiratory system |
---|---|---|---|---|---|---|
| ||||||
Chest discomfort | Allergies | Easy bruising | Acid reflux | Arthritis | Heart pain | Shortness of breath |
Cold | Autoimmune | Slow healing | Gastritis | Fibromyalgia | Heart palpitations | |
Cough | Candida | GERD | Joint pain | Heart rate disturbance | ||
Dehydration | Connective tissue | GI issues | Muscle pain | |||
Dry hair | EBV | IBS | Slow muscle recovery | |||
Fatigue | Fever | Reflux | ||||
Hair loss | Hashimoto | Leaky gut | ||||
Illness | Lupus | SIBO | ||||
Inflammation | Lyme disease | Gallbladder | ||||
Insomnia | Multiple Sclerosis | Kidney | ||||
Intolerana* | Raynaud | Liver | ||||
Metallic taste | Rheumatoid arthritis | Pancreatitis | ||||
Night sweats | Scleroderma | Acid reflux | ||||
Numbness | Sjogren | Gastritis | ||||
Premature aging | Toxic shock | GERD | ||||
Sick feeling | Yeast | GI issues | ||||
Sleep issues | IBS | |||||
Tingling | Reflux | |||||
Toxic feeling | Leaky gut | |||||
Weight changes | SIBO | |||||
Nervous system | Endocrine system | Renal and urinary system | Female reproductive system | Eye, ear, nose, and throat | Skin | Psychiatric and behavioral |
Brain Fog | Adrenal disturbance | Frequent urination | Early menopause | Choking sensation | Dry skin | Anxiety |
Headaches | Parathyroid disturbance | Urinary tract | Hormone disturbance | Ear ringing | Rash | Depression |
Migraine | Thyroid disturbance | Hysterectomy | Sinus disturbance | Panic attack | ||
Memory loss | Libido disturbance | Throat clearing | ||||
Menopause | Vertigo | |||||
Dry eyes | ||||||
Difficulty swallowing |
Intolerena refers to any mention of intolerance or intolerant
EBV Epstein-Barr virus, GERD Gastroesophageal reflux disease, GI Gastrointestinal, IBS Irritable bowel syndrome, SIBO Small intestinal bacterial overgrowth, UTI Urinary tract infection
In 2021, ASPS shows a 34.4% increase in BIR while breast augmentation surgeries decreased by 14.9% compared to reports from 2017 [4]. Between 2010 and 2020 there was a total number of 293,384 BIR surgeries and a 70% increase in BIR within those years (Fig. 3). According to a geospatial analysis of ASPS reports, “region 5” had the highest surgical demand for BIR in 2020 (13, 969 BIRs/66,517 breast augmentations), compared to all other regions (mean: 5,600/31,639 breast augmentations) [25]. This region includes Arizona, which may have experienced an increase in surgical demand due to heightened awareness of breast implant complications leading up to the 2022 Arizona Senate Bill mandating a comprehensive consent checklist for all people seeking breast implants [10, 29]. To further corroborate this point, a previous study showed a significant correlation in GT and ASPS data for BIR surgeries from 2006 to 2019 for “breast implant illness” and “breast implant removal” [23, 25].
A 2021 BII population study on a single Facebook advocacy group described that 56% of survey participants heard of BII from social media while 2% learned about it from a plastic surgeon [10]. Similar to other studies [4, 5, 13, 41], a large multicentered cohort study on 99,993 reports from the FDA’s large post approval study database from 2007 to 2014 supports the association between silicone implants and higher rates of Sjogren syndrome, scleroderma, rheumatoid arthritis [41].
The results of this study must be considered with respect to its limitations. As this study was largely observational in nature, causality could not definitively be determined. Additionally, while the internet trends presented represent a general public interest, it is impossible to isolate breast implant patient queries versus other medical and nonmedical inquiry. Further, this study aims not to determine statistical significance, but rather social significance by providing insight onto an area of social interest and understanding.
While silicone-implant related disease has been heavily reported, certain study limitations inhibit BII’s unified medical acceptance. Such limitations include poor long-term follow-up, confounding variables, selection bias, and lack of studies assessing behavioral and psychological impact [4, 13, 42]. There is great difficulty conducting high quality or institutional research studies as there is currently no International Classification of Diseases (ICD) code for BII nor a mandatory breast implant registry that unifies medical data. An ICD code has the added benefit that allows patients to file a claim with insurance companies to help with BIR surgery costs. The future of medical research for BII rests in use of breast implant registries and an ICD validation, which are both crucial for physicians to accurately document patient’s symptoms. Further high-quality studies are warranted on BII; however, it is advised that all physicians acknowledge patient distress and broach the conversation before information is sought elsewhere. Action must be taken to increase physician cognizance of BII symptoms and provide avenues for patients to express concern.
Conclusion
The presented findings suggest a correlation between public interest in BII and an increase in BIR related inquiries. The overall trends indicate a growing significance of BII in academic medicine and surgical practice, and further study is warranted to elucidate the extent of these surgical implications.
Footnotes
Conflict of interest The authors declare that they have no conflicts of interest to disclose. This article does not contain any studies with human participants or animals performed by any of the authors. For this type of study, informed consent is not required.
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