Continuing Education Activity

Paradoxical adipose hyperplasia (PAH), also known as paradoxical hyperplasia, is a rare but aesthetically unappealing complication of cryolipolysis, a popular noninvasive fat reduction procedure commonly referred to by the brand name CoolSculpting^®. PAH manifests several weeks to months after cryolipolysis, presenting as a painless, firm, and well-defined enlargement of adipose tissue localized to the treated area, leading to unintended and often aesthetically unappealing results. The incidence of PAH is higher than initially anticipated, with some estimates suggesting it may occur in up to 2% of treatments or 1 in 50 cases.

The exact cause of PAH remains unclear, but proposed mechanisms include hypertrophy of preexisting adipocytes, recruitment of preadipocytes, sympathetic denervation, alterations in receptor expression or signaling factors involved in adipocyte metabolism, hypoxic injury, and negative pressure suction. Surgical management, primarily through liposuction or direct excision, remains the standard treatment for PAH. However, recent reports suggest that noninvasive options such as deoxycholic acid may also serve as adjuncts. This activity reviews the risk factors, pathophysiology, presentation, evaluation, and treatment of PAH following cryolipolysis. This activity facilitates the assessment and mitigation of PAH risk, enhances diagnostic accuracy, and guides appropriate management, including specialist referrals when needed. The activity also emphasizes the role of an interprofessional healthcare team in applying best practices for discussing the risk of PAH with patients, managing expectations, and addressing concerns if PAH develops after the procedure.

Objectives:

• Identify the key clinical features and risk factors associated with paradoxical adipose hyperplasia following cryolipolysis to ensure accurate diagnosis.
• Implement effective patient counseling strategies before cryolipolysis about the risks of paradoxical adipose hyperplasia, including its potential aesthetic and psychological impacts.
• Select appropriate diagnostic tools, such as imaging studies, to evaluate the extent of paradoxical adipose hyperplasia and guide treatment decisions.
• Collaborate with interprofessional healthcare team members to develop comprehensive diagnostic and therapeutic plans for paradoxical adipose hyperplasia.

Introduction

Paradoxical adipose hyperplasia (PAH), also known as paradoxical hyperplasia, is a rare but aesthetically unappealing complication of cryolipolysis, a popular noninvasive fat reduction procedure commonly referred to by the brand name CoolSculpting^®. PAH manifests several weeks to months after cryolipolysis, presenting as a painless, firm, and well-demarcated enlargement of adipose tissue confined to the treatment area. The development of PAH can cause significant emotional distress for those affected. Public awareness of PAH has increased in recent years, notably after former supermodel Linda Evangelista publicly shared her struggle with the condition and its impact on her self-esteem and career.

The incidence of PAH is higher than initially anticipated, with some estimates suggesting it may occur in up to 2% of treatments or 1 in 50 cases.[1] The pathophysiology of PAH is poorly understood, but several mechanisms have been proposed, including hypertrophy of preexisting adipocytes, recruitment of preadipocytes, reduction in sympathetic innervation, changes in receptor expression and signaling factors involved in adipocyte metabolism, hypoxic injury, and negative pressure suction.[2] Treatment options typically involve removing the hyperplastic tissue through liposuction, direct excision, or a combination of both.

Etiology

The exact etiology of PAH is unknown, but identifying potential risk factors is crucial for setting patient expectations and fully understanding the risks. Unfortunately, the risk factors for PAH are also poorly understood; however, some reports suggest a correlation with certain factors, such as Hispanic background, male gender, use of a single large applicator, and treatment of the abdominal region.[3] However, many individuals affected by PAH have no known risk factors.

A set of twins has been identified that developed PAH following cryolipolysis at separate practices, indicating a potential genetic predisposition to the condition.[3] Kelly et al also proposed that increased levels of testosterone may increase the risk of PAH.[3] Interestingly, a study by Nikolis et al found that newer cryolipolysis models and applicators demonstrated a 75% decrease in PAH occurrence, indicating that mechanical defects in older models may have contributed to the higher incidence of PAH.[4]

Epidemiology

The incidence of PAH is likely underreported and may be significantly higher than initially predicted. Originally estimated at approximately 0.0051% or 1 in 20,000 treatments when first described in 2014, the reported incidence has increased as awareness of this complication has grown.[2] 

PAH reporting is typically measured per treatment or cycle, which can obscure the true risk for patients undergoing multiple treatments. Many patients receive several cycles in a single session targeting different body areas and may have repeat sessions within 4 to 8 weeks. Consequently, the cumulative risk of developing PAH may be higher than reported figures suggest. Per-cycle reporting could underestimate the overall incidence of PAH in patients undergoing multiple procedures, highlighting the need for more comprehensive risk assessments and patient counseling that account for the total number of treatments received.

The most recent manufacturer-reported incidence in 2021 estimated PAH at 0.033% or 1 in 3000 treatments. However, a 2020 systematic review by Hedayati et al found the incidence to be approximately 0.91% or 1 in 110 treatments, over 27 times higher than the manufacturer's estimate.[5] Despite the wide range of PAH incidence reported, some estimates suggest the actual rate may be as high as 2%.[1]

Pathophysiology

Cryolipolysis is a noninvasive "fat-freezing" procedure that uses controlled cooling and negative pressure to selectively target adipocytes while sparing surrounding tissue.[6] This process occurs secondary to the crystallization of cytoplasmic lipids within the adipocytes, leading to apoptosis, panniculitis, and eventual loss of the fat cells.[2] 

Although the exact pathophysiology of PAH is unknown, researchers have proposed several mechanisms that may lead to its development. These mechanisms include hypoxic injury, hypertrophy of preexisting adipocytes, sympathetic denervation, recruitment of preadipocytes, modifications in the expression of receptors and/or signaling factors involved in adipocyte metabolism, and/or secondary to negative pressure suction.[2] 

Hypoxic injury may cause adipocyte hypertrophy through various mechanisms. Stefani hypothesized that cooling adipocytes without rupturing the cell wall might result in rebound hypertrophy and hyperplasia due to hypoxic injury.[7] Hypoxic injury is also known to stimulate the release of hypoxia-inducible factors, which can lead to angiogenesis and potentially contribute to adipocyte hypertrophy and hyperplasia.[8]

Reduced sympathetic innervation, recruitment of preadipocytes, and modifications in the expression of receptors and/or signaling factors involved in adipocyte metabolism may also contribute to the development of PAH. Multiple animal studies have suggested that sympathetic denervation of adipose tissue can inhibit lipolysis and may lead to an increase in adipocyte proliferation.[9][10][11] Additionally, local inflammation stimulates the release of inflammatory cytokines, such as tumor necrosis factor-α, which can further promote the recruitment of cells for adipose tissue growth and may contribute to PAH.

Stefani also hypothesized that the negative pressure suction used during cryolipolysis may stimulate adipocytes in the treatment area.[7] This mechanical stimulation of the adipocytes can potentially stimulate cell growth and proliferation, similar to the observed effect seen in typical external tissue expansion devices. These devices involve using a suction that is applied to the breasts for several hours per day, mechanically stimulating breast tissue to promote cell growth and increase breast size. Similarly, the negative pressure suction used during cryolipolysis might have a comparable stimulatory effect on adipocytes.[7] However, further research is needed to fully understand the extent of this stimulatory effect.

Histopathology

Histopathological examination typically reveals increased septal thickening and fibrosis, enhanced vascularity, and disorganized adipocytes of varying sizes and shapes.[2][12] Interestingly, a study by Seaman et al reported a decrease in adipocyte size and vascularity when examining the pathological changes of PAH at the cellular level.[13] The authors hypothesized that their findings might be attributed to analyzing PAH tissue at a different stage in its progression, as their study was conducted 7 months after treatment, compared to 3 months in the report by Jalian et al.[2][13]

History and Physical

PAH generally presents within 12 months of cryolipolysis as a painless, firm, and well-demarcated enlargement of adipose tissue confined to the treated area. Tissue growth is gradual and generally stabilizes after several months. PAH has been reported in all approved treatment areas, including the abdomen, submentum, bra fat region, thighs, flanks, and upper arms.

A thorough history and physical examination are essential for accurately diagnosing PAH. During history-taking, clinicians should ask about the patient's cryolipolysis experience, including the treatment timeline, areas treated, and any previous aesthetic procedures. The physical examination should focus on the morphology of the affected tissue, noting the firm, bulging appearance characteristic of PAH. The shape of the affected tissue is often described as a "stick of butter" because it generally reflects the shape of the applied applicator. The affected tissue is generally firmer than the surrounding unaffected areas.

Evaluation

The evaluation of a patient with PAH involves a comprehensive clinical assessment to distinguish it from other postprocedural complications. If PAH is suspected, imaging studies are used to assess the extent of adipose tissue hypertrophy and distinguish PAH from other conditions, such as lipomas or localized fat deposits.

Ultrasound can provide insight into the thickness and density of the adipose tissues. Computed tomography (CT) and magnetic resonance imaging (MRI) of individuals with PAH reveal an increase in subcutaneous adipose tissue with normal signal intensity localized to the previously treated area.[2][12] MRI offers a detailed view of tissue architecture and helps confirm the absence of inflammatory or malignant changes. Although biopsy is rarely needed, it may be considered to rule out other pathologies. 

Treatment / Management

The effectiveness of noninvasive fat loss modalities in treating patients with PAH following cryolipolysis remains unknown. Additional sessions of cryolipolysis are not recommended, as they have been shown to aggravate PAH symptoms and lead to further tissue growth.[1] 

Cytolytic therapy, such as deoxycholic acid (DCA), has been suggested as a possible treatment for PAH. DCA is a nonsurgical alternative for submental fat reduction that received approval from the US Food and Drug Administration (FDA) in 2015 as an injectable drug. DCA is a naturally occurring bile acid produced in the human intestines that emulsifies and solubilizes dietary fats.[14] Ward et al reported a case of an individual with PAH who experienced abdominal volume reduction after three treatments with DCA, highlighting the need for further studies to evaluate its potential as a treatment modality.[15]

A recent report also suggested that combining cryolipolysis with extracorporeal shock wave therapy (ESWT) may decrease the incidence of PAH.[16] ESWT is a noninvasive procedure that utilizes acoustic shock waves to treat various urologic, musculoskeletal, and soft tissue conditions.[17] The use of ESWT in treating cellulite has grown due to its ability to stimulate blood flow, promote collagen synthesis, and enhance tissue elasticity.[17] Michon reported no cases of PAH following 2291 treatment cycles of cryolipolysis, suggesting that ESWT may help prevent PAH by providing antifibrosclerotic effects and reducing oxidative stress in the treated tissue.[16]

Surgical management is the primary treatment for PAH, typically involving liposuction and/or direct excision, such as abdominoplasty. A customized treatment plan should be developed for each patient. Liposuction can be performed independently or in conjunction with one or more additional techniques, such as power-assisted, ultrasound-assisted, or radiofrequency-assisted methods.[18] Vibration amplification of sound energy at resonance (VASER) liposuction is often used to treat PAH by precisely targeting and breaking down the dense, fibrous fat tissue characteristic of this condition. This advanced technique can help achieve smoother contours and more effective fat removal in PAH-affected areas compared to traditional liposuction methods. However, without understanding the exact mechanism of PAH, it remains uncertain whether the added stress of invasive procedures might increase the risk of relapse.[19] The treatment plan should also include considerations for postoperative care and the potential need for additional procedures to achieve optimal results. Effective treatment planning requires close collaboration with a skilled plastic surgeon and ongoing patient education to ensure a comprehensive approach to managing the original complication.

Local inflammation may influence the timing of definitive surgical correction for PAH. A recent study by Kelly et al recommends waiting at least 6 months after diagnosing PAH before proceeding with the surgical correction to ensure complete resolution of local inflammation.[20] Performing invasive procedures before the inflammation resolves may increase the risk of relapse. A study by Khan in 2019 reviewed 4 PAH cases, finding that early treatments with ultrasonic liposuction, laser lipolysis, and radiofrequency skin tightening had failed in 3 cases.[21] The authors concur that liposuction and direct excision are effective treatments for PAH but should not be performed until 6 months after diagnosis to ensure that local inflammation has resolved.

Differential Diagnosis

The differential diagnoses of PAH include seroma, hematoma, lipomas, postprocedural edema or fibrosis, panniculitis, lymphoceles, hypertrophic scarring, hernias, and weight gain. Accurately distinguishing PAH from these conditions is crucial, as PAH requires specific management approaches.

Prognosis

PAH is generally considered benign and does not pose a direct danger to the patient. However, there have been no documented cases of PAH resolving spontaneously without intervention, suggesting that patients typically require invasive procedures, such as liposuction or direct excision, to address the resulting deformity.

Patients diagnosed with PAH often need multiple surgical interventions to effectively address the affected areas. Initial treatment typically involves liposuction to remove the hypertrophic fat. However, due to the firm and fibrous nature of the tissue, results can be inconsistent, often necessitating additional surgeries. In some cases, direct excision of the tissue may be required, which can result in scarring and may necessitate further cosmetic revisions. The complex nature of PAH and its resistance to nonsurgical treatments often require patients to undergo multiple procedures over an extended period to achieve satisfactory aesthetic results. Additionally, affected individuals frequently face significant out-of-pocket expenses, as insurance typically does not cover these corrective cosmetic procedures.

A diagnosis of PAH can have significant emotional consequences for patients. The condition often leads to distress and frustration, especially as cryolipolysis is intended to reduce fat and enhance appearance. Patients may experience a loss of self-esteem and body confidence due to the disfiguring nature of PAH, which can be particularly challenging for those who sought the procedure to improve their appearance. The extended timeline for diagnosis and the potential need for corrective surgery can heighten feelings of anxiety, regret, and dissatisfaction. Increased public awareness of PAH, including high-profile cases, may also contribute to feelings of isolation or misunderstanding, further intensifying the emotional burden of the condition.

Complications

PAH can lead to several physical and psychological complications. Physically, the primary complication is the unexpected and localized increase in fat tissue, which resists further noninvasive treatments and often requires surgical intervention. The fibrous nature of the hypertrophic tissue complicates treatment with liposuction alone, sometimes necessitating more invasive procedures such as direct excision, which can result in scarring, contour irregularities, and extended recovery times. Multiple surgeries may be needed, increasing the risk of complications such as infection, hematoma, and poor wound healing.

Psychologically, the disfiguring nature of PAH can cause significant emotional distress, including anxiety, depression, and diminished self-esteem. The condition’s unpredictability and resistance to treatment further exacerbate these issues, impacting the overall quality of life for those affected.

Postoperative and Rehabilitation Care

Postoperative care for patients undergoing surgery for PAH includes several critical components to ensure optimal recovery and outcomes. Proper wound care is essential to prevent infection and promote healing. This involves keeping the area clean and dry, monitoring for signs of infection, and following any specific instructions provided by the surgeon. Effective pain management is also crucial, with prescribed medications or other pain relief methods used as directed by the healthcare professional.

Patients are typically required to wear compression garments to reduce swelling, support the healing process, and help contour the treated area. Regular follow-up visits with the surgeon are crucial for monitoring the healing process, assessing results, and addressing any complications or concerns. Adherence to activity restrictions, including avoiding strenuous exercises or movements that could strain the surgical area, is important for facilitating proper recovery. 

Consultations

Patients diagnosed with PAH often require consultations with multiple specialists to ensure comprehensive care. Initially, consulting an aesthetic physician or a physician experienced with cryolipolysis and its complications is essential for accurate diagnosis and management planning. Involving a plastic surgeon with experience in body contouring is crucial, as surgical correction is often required for patients with PAH. They can discuss the available surgical options, such as liposuction or direct excision, and help set realistic expectations for outcomes. Additionally, consulting a psychologist or counselor may be beneficial for addressing the emotional and psychological impact of PAH, particularly for patients experiencing anxiety or depression related to their appearance.

Due to current practice gaps and limited familiarity with PAH, patients often need to find a few knowledgeable specialists about this uncommon condition. Despite the widespread popularity of cryolipolysis in the United States, the small number of plastic surgeons with the necessary expertise and interest in treating PAH can necessitate long-distance travel for patients to receive care. This adds to the financial burden, resulting in significant expenses for corrective surgeries—often multiple procedures—with varying degrees of success.

Deterrence and Patient Education

Before initiating cryolipolysis, healthcare professionals must explain the risk of PAH during the informed consent process, discussing its symptoms, such as firmness, swelling, and distortion of the treated area. Patients should also be informed about the possibility of needing a corrective invasive procedure if PAH occurs. Obtaining proper informed consent is challenging when the reported risk figures provided by cryolipolysis companies may be significantly underestimated, potentially misleading patients about the actual likelihood of complications. After receiving comprehensive patient education, individuals can make informed decisions about cryolipolysis and be aware of potential complications. They can also manage their expectations more effectively, thereby leading to a smoother treatment experience.

Social media support groups for patients with PAH offer a crucial platform for individuals to share their experiences, seek advice, and find emotional support from others facing similar challenges. These online communities facilitate connections with those who understand the physical and emotional impact of PAH, providing a space to discuss treatment options, postoperative recovery, and coping strategies. Additionally, these groups can raise awareness about PAH, educate others about this complication of cryolipolysis, and advocate for more research and improved patient care.

Pearls and Other Issues

The ethical concerns surrounding cryolipolysis, particularly CoolSculpting^® by Allergan, are multifaceted.CoolSculpting^®, a widely marketed noninvasive fat reduction technique, is often promoted as a quick and easy solution for unwanted fat. This has led to its popularity, particularly in medspas, where individuals with limited medical training sometimes perform the procedure. This raises significant ethical questions regarding patient safety, informed consent, and the quality of care provided.

When non-physicians administer cryolipolysis without close supervision by a qualified physician, the risk of complications such as PAH may be underestimated or inadequately managed. Patients might not receive thorough counseling about potential risks, such as developing PAH, paradoxically increasing fat in the treated area, and resulting in disfigurement. The absence of medical oversight in these settings can lead to delayed recognition of PAH, inadequate management, and insufficient follow-up care.

Furthermore, the ethical implications are compounded by the financial motivations driving the expansion of cryolipolysis in non-clinical settings. The profit-driven focus of medspas may prioritize sales and patient throughput over careful patient selection and thorough risk communication. Commercializing a medical procedure without adequate safeguards raises concerns about whether patients are genuinely informed about the risks and whether their care is truly in their best interest.

Allergan, the manufacturer of CoolSculpting^®, also faces ethical scrutiny for its role in promoting the procedure while managing the fallout from PAH cases. Reports of the company offering financial settlements to PAH patients in exchange for nondisclosure agreements complicate the ethical landscape. Such practices may be perceived as attempts to silence those with adverse outcomes, potentially limiting public awareness and hindering a broader understanding of PAH's risks.

The ethical issues surrounding cryolipolysis include concerns about non-physician administration in medspa settings and broader corporate practices for managing PAH complications. Ensuring patient safety, promoting transparency, and prioritizing informed consent are critical ethical responsibilities in the expanding market for cosmetic procedures such as cryolipolysis.

Enhancing Healthcare Team Outcomes

PAH management benefits from a multidisciplinary approach to optimize patient care and outcomes. A cohesive healthcare team—comprising plastic surgeons, radiologists, pathologists, and psychologists—can significantly enhance the management of PAH. Plastic surgeons are critical to the clinical diagnosis and treatment of PAH. Plastic surgeons are critical in the clinical diagnosis and treatment of PAH. Radiologists and pathologists aid in accurately diagnosing the condition through imaging and examination of the tissue, respectively. Psychologists also contribute by addressing the psychosocial impact of PAH and providing support and counseling to affected patients. Collaborative efforts among these specialists can deepen the understanding of PAH, facilitate the creation of effective treatment plans, and ultimately improve patient outcomes in managing this challenging condition.

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Disclosure: Demitri Franzoni declares no relevant financial relationships with ineligible companies.

Disclosure: Joshua Goldman declares no relevant financial relationships with ineligible companies.