Findings Consistent with a Breast Implant–associated Somatic System Disorder (BIA-SSD) Among Patients Self-reporting Breast Implant Illness

Abstract

Background:

Self-reported breast implant illness (BII) has been found to be associated with anxiety as well as medically diagnosed anxiety and depression. Somatic symptom disorder (SSD) is a relatively common mental health condition that includes anxiety and somatic symptoms, often without a clear cause.

Methods:

We evaluated patients with BII symptoms, with or without a history of an anxiety disorder, for findings consistent with SSD. A total of 120 women were evaluated in 2 cohorts, 60 women with somatic symptoms and breast implants desiring explantation as well as 60 women desiring explantation without BII symptoms. Patient demographics, a patient survey, and validated anxiety scale and somatic symptom scale measurements were obtained.

Results:

Patients with a history of an anxiety disorder and BII symptoms had very high levels of anxiety and highly elevated somatic symptom scores. Patients with a combined diagnosis of anxiety and BII symptoms demonstrated an SSD prevalence of 70.2%, with the difference between the BII/anxiety group and other groups statistically significant (P < 0.01). Other patients with BII symptoms and no history of anxiety had a lower SSD prevalence (21.7%). Patients without a history of BII had little to no SSD inclusion.

Conclusions:

Our data suggest that a significant subset of patients with somatic symptoms have findings consistent with a breast implant–associated somatic symptom disorder. Patients with persistent or excessive thoughts about somatic symptoms will benefit from counseling and referral to an SSD specialist if they wish to maintain breast implants.

Takeaways

Question: Other than anxiety, is there a known mental health finding in patients with self-reported breast implant illness (BII)?

Findings: Patients self-reporting BII were found to have severe anxiety and a high burden of somatic symptoms. Furthermore, 70.2% of patients with a history of anxiety were also found to have persistent or excessive worry about their implants for 6 months or more. These findings were consistent with a somatic symptom disorder associated with breast implants.

Meaning: Some patients with self-reported BII have findings consistent with a breast implant-associated somatic symptom disorder and may benefit from medical counseling and SSD therapy for symptomatic improvement.

INTRODUCTION

Recent studies have demonstrated that self-reported breast implant illness (BII) is associated with high levels of anxiety and depression assessed using validated psychometric measures.^1–5 Patients also report a variety of somatic symptoms that they attribute to their breast implants,^4,5 including fatigue, joint or muscle pain, “brain fog,” anxiety/depression, and rash, despite a lack of data supporting this association. Many patients self-reporting BII symptoms have indicated that their somatic symptoms are persistent, have been present for 6 months or longer, and are associated with health concerns. These findings have been consistent among many studies evaluating patients who are concerned that their breast implants are the source of their mental and physical symptoms and give rise to the possibility that a mental health condition may be associated with these findings.

In 2013, The American Psychiatric Association introduced the diagnosis, “somatic symptoms disorder” or SSD in the Diagnostic and Statistical Manual of Mental Disorders, fifth edition.⁶ For the diagnosis of SSD, there must be 3 specific criteria present (1, 2, and 3):

• 1.One or more somatic symptoms that are distressing or result in significant disruption of daily life.
• 2.Excessive thoughts, feelings, or behaviors related to the somatic symptoms or associated health concerns and manifested by at least 1 of the following:
  • a.High level of anxiety about health or symptoms;
  • b.Disproportionate and persistent thoughts about the seriousness of one’s symptoms;
  • c.Excessive time and energy devoted to these symptoms or health concerns.
• 3.Although any one somatic symptom may not be continuously present, the state of being symptomatic is typically more than 6 months.

Patients diagnosed with SSD have a significant focus on physical symptoms, which have been present for at least 6 months. A medical cause for symptoms may or may not be present. SSD may be diagnosed concurrently with other physical or mental health diagnoses.

Patients reporting BII symptoms have been shown to possess a higher rate of anxiety-related disorders, take more medications for anxiety-related conditions, and undergo more mental health counseling than other patients who do not have somatic symptoms.⁷ Some patients have also been found to have persistent thoughts about somatic symptoms for durations of time in excess of 6 months. These findings suggested the possibility of SSD associated with breast implants. This study evaluates the presence of SSD diagnostic criteria among 2 cohorts of patients desiring explantation, one cohort with BII symptoms and the other without BII symptoms. Anxiety scores and somatic symptom burden scores were determined for patients with or without BII symptoms, to explore the role that a history of an anxiety disorder plays in the process.

METHODS

A retrospective review, patient survey, and collection of both anxiety- and somatic-scale measurements were conducted on a cohort of 120 consecutive biologically female patients, 30–60 years of age. The first cohort consisted of 60 women who self-reported BII symptoms and who underwent explantation with total capsulectomy and mastopexy. The second cohort included women who desired explantation, total capsulectomy, and mastopexy, and did not have BII symptoms. Patients were classified by the presence or absence of a history of a diagnosed anxiety disorder, which included either an isolated anxiety disorder or an anxiety/depression disorder. The diagnosis of an anxiety or anxiety/depression disorder disclosed by patients was made by a primary care physician, psychiatrist, or licensed psychologist. Patients having treatment for anxiety, either psychological or medical/pharmacological, were included in the anxiety grouping.

Data were collected by chart review; a patient survey; and both a validated anxiety scale test, General Anxiety Disorder-7 (GAD-7),⁸ and a somatic symptom scale, Somatic Symptom Scale-8 (SSS-8).⁹ (See table, Supplemental Digital Content 1, which displays anxiety scale before the removal of breast implants, http://links.lww.com/PRSGO/D633.) (See table, Supplemental Digital Content 2, which displays the patient survey, http://links.lww.com/PRSGO/D634.) (See table, Supplemental Digital Content 3, which displays the SSS-8 scale for breast implant concerns, http://links.lww.com/PRSGO/D635.)

Data collected encompassed patient age, body mass index, implant characteristics (saline versus silicone, texture, size, shape, age, and integrity noted at surgery), and capsular contracture (Baker 3 or 4). The reasons that explantation was performed was recorded. The patient survey was conducted as an interview and provided questions about mental health history and concerns regarding breast implants as a cause of somatic symptoms. The survey assessed each of the criteria required for an SSD diagnosis, including a history of anxiety, the presence of an anxiety-related disorder, persistent thoughts or worry about somatic symptoms, frequency and duration of symptoms, and symptoms following explantation. The patient survey was designed by a psychiatrist specializing in the evaluation of SSD.

The GAD-7 and SSS-8 were provided to patients to assess anxiety levels and somatic symptom burden experienced before removal of breast implants. The GAD-7 uses a scale from 0 to 21 and assigns scores of 0, 1, 2, and 3 to each of 7 response categories based on the frequency of feeling anxious over a period of time. GAD-7 total score for the 7 items ranges from 0 to 21: 0–4, minimal anxiety; 5–9, mild anxiety; 10–14, moderate anxiety; and 15–21, severe anxiety. The SSS-8 test for somatic symptoms provides scores of 0 to 32, with a score of 0–3 showing no or minimal symptom burden, 4–7 showing low burden, 8–11 showing medium burden, 12–15 showing high burden, and 16–32 showing very high burden. Mean GAD-7 and SSS-8 scores were calculated for patients with or without a history of anxiety disorder.

Patients were considered to have findings consistent with SSD when elevated anxiety levels assessed by both patient survey and GAD-7 testing was found with high levels of somatic symptom burden, findings of excessive thoughts or feelings about symptoms, and duration of symptoms for 6 months or more. Data were collected between December 2023 and March 2024 and were approved by Tier IRB (Kansas City, MI).

Statistical Analysis

The χ² test was used to compare independent groups on categorical variables. Unpaired samples t test was conducted to compare the groups on normal, continuous outcomes, with means and SDs reported for the t test analyses. For continuous outcomes inconsistent with statistical assumptions, Mann-Whitney U tests were executed to compare the groups, and medians and interquartile ranges were reported for the nonparametric analyses. In the analysis to evaluate a potential relationship between capsular contracture, anxiety, and SSD, a logistic regression was utilized to evaluate multiple variables to predict for a categorical outcome.

RESULTS

Table 1 presents the demographics of the studied patients and breast implant related data. No significant differences were observed in patient age; body mass index; or implant factors such as breast implant size, shape, surface type, and the presence of capsular contracture. No differences in implant ruptures were noted between patients undergoing explantation, with or without symptoms. Patients with self-reported BII were explanted based on patient request and their belief that their somatic symptoms were related to the presence of breast implants.

Table 1.

Patient Demographics and Implant Factors for Patients Undergoing Explantation, with or without Anxiety and BII Symptoms

Variable/Level	Symptoms, Anxiety Explant	Symptoms, No Anxiety Explant	No Symptoms Explant
Patients
Number	37	23	60
Age, y	46.8 (43.0–51.0)	48.3 (44.1–52.0)	47.0 (42.0–52.5)
BMI, kg/m2	25.8 (24.8–27.1)	26.5 (25.2–27.5)	26.6 (24.8–27.5)
Implant factors
Size	335.7 (300.1–368.3)	328.6 (298.4–362.9)	330.0 (290.1–365.0)
Rupture (%)	9.3	17.4	24.1
Type (%)
Saline	10	15	12.5
Silicone	90	85	87.5
Surface (%)
Smooth	75.3	79.1	85.0
Textured	20.2	24.4	15.0
Shape (%)
Round	94.0	94.4	98.3
Shaped	6.0	5.6	1.7
Capsular (%)	22.4	24.2	31.7
Contracture
(Baker 3 or 4)

Table 2 shows GAD-7 anxiety scale and SSS-8 somatic symptom scale measurements of patients with or without BII symptoms and a history of an anxiety disorder. Patients with BII symptoms and a history of anxiety demonstrated the highest anxiety and somatic symptom scores, with severe anxiety (17.1) and a very high somatic system burden score (25.2) relating to the presence of breast implants. Patients with BII symptoms and no history of an anxiety disorder showed moderate anxiety (11.8) and high somatic symptom burden scores (14.2), whereas patients without a history of BII symptoms demonstrated low to minimal levels of anxiety (5.7, 3.3) and medium to low somatic symptom burden scores (8.1, 4.4) related to their breast implants. There were significant differences between the groups for patients with BII symptoms when evaluating both GAD-7 and SSS-8 scale values, with a P value of less than 0.001.

Table 2.

GAD-7 Anxiety Scale and SSS-8 Somatic Symptom Scale Measurements of Patients with or without BII Symptoms and History of an Anxiety Disorder

Group	GAD-7 Anxiety Scale	SSS-8 Somatic Symptom Scale
BII with history of anxiety DO (n = 37)	17.1±2.1*	25.2 ± 1.9*
BII no history of anxiety DO (n = 23)	11.8±2.2	14.2±2.3
No BII, with history anxiety DO (n = 16)	5.7±1.8	8.1±2.6
No BII, no history of anxiety DO (n = 44)	3.3±1.6	4.4±2.0

DO, disorder.

GAD-7 Anxiety scale measures 0–21, with 0–4: minimal anxiety; 5–9: mild anxiety; 10–14: moderate anxiety; and 15–21: severe anxiety.

SSS-8 Somatic Symptom Scale measures 0–32, with of 0–4 showing no or minimal symptom burden, 4–7 showing low burden, 8–11 showing medium burden, 12–15 showing high burden, and 16–32 showing very high burden.

^*P < 0.001.

Table 3 shows the number and prevalence of patients with BII symptoms meeting the diagnostic criteria for SSD. An overall prevalence of 51.6% of SSD was found in patients with BII symptoms. Patients with both BII symptoms and anxiety demonstrated an SSD prevalence of 70.2%, with the difference between the BII/anxiety group and other groups statistically significant (P < 0.01). Other patients with BII symptoms and no history of an anxiety disorder had a lower prevalence of SSD (21.7%). Patients without a history of BII had little to no SSD inclusion.

Table 3.

Number and % of Patients, With or Without BII Symptoms and an Anxiety Disorder, Demonstrating Findings Consistent with SSD Related to Worries about Breast Implants

Group	Presence of Elevated Anxiety, Excessive, or Persistent Worry about Somatic Symptoms and Symptom Duration for 6 or More Months
BII patient cohort (n = 60)	31/60 = 0.516
BII with history of anxiety DO (n = 37)	26/37 = 0.702*
BII with no history of anxiety DO (n = 23)	5/23 = 0.217
Implant removal, no BII cohort (n = 60)	2/60 = 0.033
No BII, history of anxiety DO (n = 12)	2/12 = 0.166
No BII, no history of anxiety (n = 48)	0/48 = 0

DO = disorder.

^* P < 0.01.

There were no differences between patients with SSD or without SSD in relation to capsular contracture (P = 0.56) or between anxiety and capsular contracture (P = 0.25. Logistic regression demonstrated that neither the presence of anxiety nor SSD was found to predict for capsular contracture (P = 0.7).

DISCUSSION

Recent studies have provided a greater understanding of the contribution of anxiety-mediated processes to self-reported BII. The hypothesis that some patients with self-reported BII may possess findings consistent with an SSD developed when patients in a recent study were noted to have anxiety, persistent thoughts about somatic symptoms that they attributed to their breast implants, and symptom duration over 6 months.⁷ These findings are the hallmarks of SSD. The current study investigates self-reported BII patients in more detail, with a focus on how the history of an anxiety disorder correlates with anxiety about breast implants and somatic symptom severity. Our results suggest that some patients with self-reported BII desiring the removal of their breast implants meet the criteria for the diagnosis of SSD, and that the prevalence of SSD findings is greater in patients with BII symptoms who have a history of an anxiety disorder. These results are supported by several studies which explore the relationship between anxiety and BII symptoms. Patients self-reporting BII symptoms have been shown to have high levels of anxiety associated with symptoms,^4,5 and BII symptoms have been shown to be statistically predictive of an anxiety-related disorder.⁷

The current etiology of SSD is believed to be of neuropsychiatric origin.^10,11 The processes are mediated centrally such that psychological stress and anxiety affect neural circuits which control peripheral functions and create somatic symptoms. SSD and related disorders are relatively common, affecting an estimated 5%–7% of the general population and 5%–15% of the aesthetic surgery population.^6,12 Up to 50% of patients with SSD have anxiety disorders,¹³ making patients with a history of anxiety and high levels of anxiety regarding a particular concern, such as breast implants, particularly susceptible.

It is estimated that genetic factors also contribute to the perception of bodily distress in up to 30% of patients, thereby creating a mechanism for the development of symptoms.¹⁴ SSD has also been associated with personality disorders or certain personality traits, which effect how body symptoms are perceived. Other factors found to be associated with SSD include childhood neglect, sexual abuse, substance abuse, organic illnesses, stress, cognitive issues, and adverse life events.¹⁵ We did not study these factors or personality traits in our patients, and therefore, further study of SSD associations will be helpful.

Psychiatrists and psychologists utilize various modalities to formally diagnose SSD, including somatic symptom and anxiety testing, mental status evaluation, interview, and other techniques. In our study, we did not perform a psychiatric examination of patients, but we were able to demonstrate the presence or absence of hallmark features which would be consistent with SSD related to the presence of breast implants. The Diagnostic and Statistical Manual of Mental Disorders, fifth edition defines the criteria for the diagnosis of SSD.⁶ Typically, patients have 1 or more somatic symptoms, for at least 6 months, associated with excessive thoughts, feelings, or behaviors typically manifested through high levels of anxiety about their health or symptoms. Many patients in our study reported somatic symptoms with a very high level of somatic symptom burden through SSD-8 scale evaluation, high levels of health anxiety though both a questionnaire and GAD-7 testing, and duration of symptoms for 6 months or more, supporting inclusion criteria for SSD. We were also able to determine that both anxiety and somatic symptom burden were greatest in patients with BII symptoms, especially among patients with history of an anxiety disorder.

We chose simple but highly validated measurement tools to assess levels of anxiety and somatic symptoms which patients felt were associated with their breast implants. The GAD-7 is an efficient and valid self-report anxiety measure that has been used to evaluate anxiety symptoms in response to stressors, stimuli, and negatively perceived stimuli.⁸ It was felt to be useful to assess the anxiety levels of patients before the removal of breast implants. We found that patients with BII symptoms possess high levels of anxiety regarding their breast implants, and those patients with the highest anxiety scores have a history of an anxiety disorder. It would make sense that patients desiring explantation with a history of an anxiety disorder would manifest high levels of anxiety with worries about breast implants, and our findings support that relationship.

The somatic symptom scale (SSS-8) has been shown to be a very accurate and reliable method to identify somatic symptom severity.⁹ When in combination with elevated anxiety levels, reported excessive or persistent thoughts, feelings or behaviors related to the somatic symptoms, the SSS-8 is a useful tool for supporting SSD findings. Our data show that patients who have a history of an anxiety disorder and somatic symptoms have very high somatic symptom burden. Patients without a history of an anxiety disorder have medium ratings of somatic symptom burden and a lower SSS-8 scale. These patients do report somatic symptoms, but the number of symptoms and the severity are reduced. These findings are supported by research showing an association between anxiety/depressive disorders and high SSS-8 scores.^16–18

Although some patients in the BII symptom group demonstrated the hallmarks of SSD, some patients with BII symptoms had no history of anxiety and lower anxiety levels. These patients may have an identifiable systemic illness or other factor accounting for their symptoms. There are many systemic illnesses and other factors which may mimic or overlap the somatic symptoms that patients attribute to their breast implants. For example, fibromyalgia, chronic fatigue syndrome, hypothyroidism, autoimmune diseases, menopausal changes, side effects of medications, and other causes have been found to produce similar symptoms.¹⁹ A medical workup to rule out other causes for symptoms is an important part of the care of patients with BII symptoms. In some cases, resolution of symptoms may be achieved with targeted treatment of conditions not related to breast implants.

Multiple studies have shown that self-reported BII symptoms often improve with the removal of breast implants.^4,20,21 By removing the source of the underlying anxiety, patients who were worried about their breast implants as a source of symptoms likely obtained relief. This hypothesis is supported by numerous studies which have demonstrated the physiological effects of the nocebo effect at reducing somatic symptoms.^22-24

Some of the patients in our study who did not have a history of anxiety or did not have excessive thoughts about symptoms may have either a local implant-based cause or a systemic cause for symptoms. Discomfort or pain can cause anxiety about breast implants, and anxiety can lead to other symptoms, including sleep disturbance, fatigue, and memory issues.^25,26 Patients can interpret these symptoms as BII, although they originated from local causes. Other patients may have a yet-unknown cause of systemic reaction to a breast implant. A group of theoretical causes of systemic symptoms associated with breast implants have been proposed, such as ASIA syndrome,²⁷ but at the current time, there is no definitive proof of a specific implant-associated systemic cause for symptoms. Most reports suggesting an adjuvant-based cause for symptoms have been case reports or anecdotal suggestions without definitive causal data.^28–30 Further research will be necessary to prove if there is a systemic contribution to symptoms directly caused by breast implants.

One of the most important elements of SSD is the fact that other comorbidities or co-diagnoses may be associated. Although our data support that there may be a neuropsychiatric component of self-reported BII for some patients, this does not exclude potential physical systemic causes should those be found in future research. Therefore a co-diagnosis of SSD associated with breast implants and another diagnosis can exist mutually.

There were several limitations to this study. Our data were largely retrospective, allowing for the entry of selection and recall bias. Patients with more interest in completing anxiety and somatic scale surveys may have been more likely to complete the questionnaires with careful thought. We suggest that a prospective study evaluating the factors required to support a diagnosis of SSD be conducted to further support our findings.

The findings of this study and those of other investigators^4,5,7 demonstrate that anxiety plays an oversized role in symptoms associated with worries about breast implants. We believe that there are enough data to recommend that patients with anxiety, and especially those with a diagnosed anxiety disorder, should be counseled by their surgeons about the relationship between worries about breast implants, symptoms, and anxiety. If a patient has a mental health professional that they have worked with, it is helpful for the surgeon to contact the mental health professional for patient counseling and treatment before surgery to reduce postoperative problems. We also suggest that the written consents for breast implants should also include information that anxiety has been linked with BII symptoms.

IMPLICATIONS

Our study findings support a linkage between the presence of anxiety and SSD in patients with BII and suggest that plastic surgeons should carefully screen patients for signs of both anxiety and SSD to help direct appropriate treatment. This may involve both mental health care to reduce anxiety and surgical care if appropriate.

CONCLUSIONS

Some patients with self-reported BII demonstrate elevated levels of anxiety about their breast implants, somatic symptoms with high somatic symptom burden, and excessive thoughts or worries about their health or symptoms which persist for 6 months or more. These are findings consistent with a breast implant–associated SSD. Although the exact mechanism for the development of somatic symptoms has not been determined, the contribution of a somatic system disorder is suggested as a contributing mechanism. Further prospective study of an SSD associated with self-reported BII symptoms is suggested.

DISCLOSURE

The authors have no financial interest to declare in relation to the content of this article.