Is EMSELLA Safe?

For appropriately selected patients, EMSELLA is a non-invasive pelvic floor treatment that has generally been well tolerated in published clinical studies.

Good tolerability in a study describes the participants, treatment and follow-up that were assessed. It does not remove the need to screen for contraindications or to report unexpected symptoms during an individual session.

Who May Not Be Suitable for EMSCULPT NEO or EMSELLA? · Is treatment painful?

EMSELLA uses high-intensity focused electromagnetic technology, or HIFEM, to stimulate repeated contractions of the pelvic floor muscles while you remain seated and fully clothed.

There are:

EMSELLA is also included in the Australian Register of Therapeutic Goods, with BTL Australia listing the device under ARTG 302821 for pelvic floor muscle strengthening across a range of genitourinary indications. [1]

However, non-invasive does not mean appropriate for everybody.

The most important safety question is not simply:

"Is EMSELLA safe?"

It is:

"Is EMSELLA safe and appropriate for me?"

That is why treatment at ¹EM begins with clinical assessment rather than simply booking every patient directly onto the chair.

In Australia, the more accurate terminology is that the relevant medical device is included in the Australian Register of Therapeutic Goods, or ARTG.

BTL Australia identifies EMSELLA under ARTG 302821.

The Therapeutic Goods Administration records ARTG 302821 as an active Class IIa medical device supplied by BTL Medical Technologies Pty Ltd and manufactured by BTL Industries Limited. [1]

Being included in the ARTG does not mean that a treatment has zero risk or that it is appropriate for every individual.

Medical-device regulation and individual treatment suitability are different questions.

BTL Australia states that EMSELLA is intended to provide pelvic floor muscle strengthening for treatment of genitourinary disorders including:

[2]

At ¹EM, the presence of one of these concerns does not automatically make somebody suitable for treatment.

Dr Emir first considers the individual presentation and relevant medical history.

Published research has generally reported good short-term tolerability in appropriately screened patients.

A clinical study involving 75 women with stress, urge or mixed urinary incontinence evaluated six HIFEM treatments.

Participants underwent medical-history screening before treatment, and the study was specifically designed to assess both safety and effectiveness. [3]

A more recent study involving 35 women with stress or mixed urinary incontinence used six EMSELLA® sessions delivered twice weekly. The researchers reported significant improvements in urinary symptoms and described HIFEM as being safely administered within the study population. [4]

A 2025 systematic review and meta-analysis examined seven studies of HIFEM for female urinary incontinence.

Most included studies did not highlight significant safety concerns.

The researchers concluded that current published evidence suggests HIFEM may be a safe and effective non-invasive treatment for female urinary incontinence, while also noting that larger, higher-quality trials are still needed because the existing evidence varies in design and quality. [5]

Yes.

A 2025 study evaluated EMSELLA in 27 men with persistent urinary incontinence after radical prostatectomy.

Participants received:

No adverse events were reported during the study.

The researchers concluded that HIFEM appeared to be a promising non-invasive treatment option in this patient group while appropriately calling for larger and longer-term research. [6]

This is relevant because EMSELLA is used at ¹EM for both men's and women's pelvic health.

Related article: Does EMSELLA Help Men as Well?

EMSELLA® generates a rapidly changing electromagnetic field.

This field stimulates motor nerves supplying the pelvic floor and produces repeated contractions of the pelvic floor muscles.

You feel the muscles contracting while you remain seated.

The treatment is therefore intentionally producing a biological effect.

That is the point of treatment.

It is also why appropriate medical screening matters.

Most patients experience sensations such as:

BTL Australia describes treatment as producing tingling and pelvic floor contractions while the patient remains fully clothed. [2]

The intensity is adjusted during treatment according to the individual treatment plan and patient tolerance.

A typical session takes approximately 30 minutes.

EMSELLA should generally feel intense rather than painful.

You should expect the pelvic floor muscles to contract repeatedly.

That can feel unusual, particularly during an initial treatment.

However, you should not simply endure unexpected or uncomfortable pain.

BTL's Australian safety information specifically instructs treatment providers to stop therapy if the patient reports uncomfortable pain. [2]

At ¹EM, patients are encouraged to communicate during treatment.

The aim is effective muscle stimulation, not proving how much discomfort someone can tolerate.

Potential effects associated with electromagnetic muscle stimulation can include:

The treatment creates repeated muscular contractions, so temporary muscular sensations afterwards are biologically plausible.

Serious adverse events have not been prominent in the published EMSELLA® urinary-incontinence literature, but that does not mean adverse effects are impossible.

Safety depends substantially on appropriate patient selection and respecting contraindications.

For most suitable patients, EMSELLA does not require a surgical recovery period.

BTL advises that patients can generally return to their normal daily activities immediately after treatment. [2]

There are no incisions or anaesthetic from which to recover.

This is one of the practical reasons many patients are attracted to the treatment.

EMSELLA is not suitable for everybody.

Important contraindications and safety considerations include certain:

BTL Australia's current provider information specifically states that EMSELLA® should not be applied when a patient has electronic or metal implants. [2]

Clinical studies of EMSELLA® have also excluded patients with pregnancy, metallic implants, pacemakers and other relevant contraindications. [3]

Related article: Who May Not Be Suitable for EMSCULPT NEO or EMSELLA?

No.

A cardiac pacemaker is an implanted electronic device, and strong electromagnetic fields can potentially interfere with implanted electronics.

A pacemaker is therefore a contraindication to EMSELLA® treatment.

This is not something that an online answer, reception or the treating team should override based on how far the pacemaker appears to be from the pelvis.

If you have a pacemaker, tell the ¹EM team before your appointment.

The same principle applies.

Implanted defibrillators are active electronic devices and are contraindications to treatment with strong electromagnetic stimulation.

Tell us exactly what it is.

Examples can include:

Do not assume that switching a device off makes EMSELLA safe.

The device itself still needs to be considered.

Metal implants require careful assessment and may make EMSELLA unsuitable.

BTL Australia's current EMSELLA® information states that treatment should not be applied in patients with electronic or metal implants. [2]

Implant-specific suitability requires clinical review.

The phrase "metal implant" can describe many different things, including:

At ¹EM, Dr Emir may need to establish:

If necessary, operative notes, imaging or implant records can be reviewed.

Clinical assessment does not override a manufacturer contraindication.

If the implant means EMSELLA cannot safely be used, treatment does not proceed.

Tell us before treatment.

A hip replacement is particularly relevant because EMSELLA® generates an electromagnetic treatment field around the pelvic region.

Published EMSELLA® research has excluded participants with metallic implants involving the pelvis or hip region. [7]

The presence of a hip prosthesis should therefore never be dismissed as irrelevant.

Tell us exactly which type you have.

Some intrauterine devices contain metal.

Published EMSELLA studies have specifically excluded IUDs containing metallic components. [7]

Do not have an IUD removed simply to pursue EMSELLA without first discussing the contraceptive and medical implications with the clinician responsible for your reproductive healthcare.

The first step at ¹EM is identifying the device.

No.

¹EM does not perform EMSELLA during pregnancy.

Pregnancy has also been an exclusion criterion in published HIFEM studies. [3,7]

If you are pregnant, treatment should be postponed.

If you think you might be pregnant, tell the team before treatment.

It can be appropriate for selected postpartum patients, but timing matters.

At ¹EM, EMSELLA is not performed during pregnancy or within the early postpartum recovery period.

After that, Dr Emir considers factors including:

The fact that someone has been cleared at a routine postpartum review does not automatically mean every elective pelvic-floor treatment is immediately appropriate.

Related article: Can I Have EMSELLA After Pregnancy or Birth?

Tell us what surgery you had and when.

EMSELLA produces powerful involuntary pelvic floor contractions.

If surgery involved tissues that are still healing, strong muscular contraction may be inappropriate.

Recent surgical procedures have therefore been included among treatment contraindications in device safety information and clinical study screening. [3]

Dr Emir may need to review:

before deciding whether treatment should proceed.

Potentially, once appropriate healing has occurred.

EMSELLA has been specifically studied in men experiencing persistent urinary incontinence following radical prostatectomy.

The 2025 study of 27 men reported improvements following treatment without adverse events during the study period. [6]

However, that does not mean treatment should begin immediately after prostate surgery.

Your:

should be considered first.

Related article: Does EMSELLA Help Men as Well?

For appropriately selected patients, urinary incontinence is one of the best-studied applications of HIFEM pelvic floor treatment.

Studies have included people with:

The 2025 systematic review found significant improvements in several urinary outcomes and reported that most studies did not highlight significant safety concerns. [5]

Assessment still matters because not every urinary symptom is caused by pelvic floor weakness.

Related article: Can EMSELLA Help With Urinary Incontinence?

EMSELLA® is included by BTL Australia for pelvic floor strengthening in relation to erectile dysfunction. [2]

However, erectile dysfunction can arise from:

For that reason, ¹EM does not simply treat erectile dysfunction as a weak-pelvic-floor diagnosis.

Dr Emir assesses whether pelvic floor rehabilitation appears relevant and whether anything else requires medical evaluation.

Related article: Can EMSELLA Support Men With Erectile Dysfunction?

No.

No medical-device treatment should be represented that way.

ARTG inclusion means the device is legally included in Australia's therapeutic goods framework for its applicable intended purpose.

It does not mean:

At ¹EM, regulatory status is one part of the safety picture.

Clinical suitability is another.

Because pelvic floor symptoms can overlap with broader medical problems.

For example, urinary leakage may be related to pelvic floor weakness.

But urinary urgency, frequency or erectile dysfunction can also have causes that deserve further clinical evaluation.

The ¹EM pathway therefore considers more than whether somebody would like to try the chair.

Depending on your presentation, assessment can include:

What is actually happening and how long has it been happening?

Conditions or treatments that could affect suitability.

Particularly pelvic, abdominal, orthopaedic, prostate and urological procedures.

Electronic and metallic implants need to be specifically identified.

Relevant medication history forms part of clinical assessment.

Treatment is not performed during pregnancy.

The likely role of pelvic floor strengthening should match what you actually want to improve.

¹EM operates within a doctor-led clinical framework.

The purpose is to make sure questions requiring medical judgement can be appropriately assessed rather than delegated to an AI assistant or treated as purely administrative.

Where your history is straightforward, much of the treatment pathway can be delivered efficiently by the trained clinical team.

Where something requires medical judgement, Dr Emir can review the case.

Complex situations may involve:

This gives ¹EM a structured way to distinguish routine treatment from cases that genuinely require more clinical investigation.

Our online assistant can explain general treatment information and recognised contraindications.

An online answer cannot medically clear you for EMSELLA.

If your question depends on:

the appropriate answer is to involve the clinical team.

Tell the treating clinician immediately.

Unexpected pain, significant discomfort or another unusual sensation should not simply be ignored because the treatment is supposed to feel strong.

BTL's Australian guidance specifically says therapy should be stopped if the patient experiences uncomfortable pain. [2]

Treatment can then be reassessed.

This distinction matters.

Non-invasive describes how the treatment is delivered.

EMSELLA does not require:

Risk-free would imply there are no circumstances in which treatment could cause harm.

That is not a responsible description of any active medical-device treatment.

EMSELLA® creates strong electromagnetic stimulation specifically because it is intended to activate muscle.

Proper screening therefore remains part of responsible treatment.

The safety process begins before the first session.

Relevant medical history and contraindications are identified.

Patients are specifically asked about metallic and electronic implants.

The reason for treatment and relevant symptoms are established.

Complex cases are reviewed by Dr Emir rather than relying on a generic checklist.

Treatment intensity is progressed according to the individual patient and treatment plan.

Patients are encouraged to report unexpected discomfort.

New medical information or changes in symptoms should be disclosed during the treatment course.

Safety screening is therefore not simply something that happens once and is forgotten.

For appropriately selected patients, published studies have generally found EMSELLA and HIFEM pelvic floor treatment to be well tolerated.

It still has important contraindications, which is why assessment occurs before treatment.

The more accurate Australian terminology is that the device is included in the Australian Register of Therapeutic Goods.

BTL Australia lists EMSELLA® under ARTG 302821.

Yes, for appropriately selected women.

Published clinical studies have evaluated EMSELLA and HIFEM across stress, urge and mixed urinary incontinence and postpartum pelvic floor dysfunction.

It may be safely used in appropriately selected men.

Clinical research has evaluated EMSELLA specifically in men with urinary incontinence following radical prostatectomy.

Treatment should generally feel like strong pelvic floor contractions rather than pain.

If you experience uncomfortable pain, tell the clinical team immediately.

Temporary muscular sensations such as soreness, fatigue or spasm may occur.

Published EMSELLA urinary-incontinence studies have generally reported good short-term tolerability.

No.

Pacemakers are active electronic implants and are contraindications to strong electromagnetic treatment.

Metal implants must be disclosed and can make treatment unsuitable.

An implant needs clinical review.

No.

Potentially, after appropriate postpartum recovery and clinical assessment.

Potentially, once appropriate healing has occurred and treatment has been clinically assessed.

EMSELLA® has specifically been studied for post-prostatectomy urinary incontinence.

No.

You remain fully clothed during EMSELLA treatment.

No.

EMSELLA does not use an internal treatment probe.

Yes.

Treatment suitability is assessed before beginning your program.

EMSELLA has a reassuring published safety profile in appropriately selected patients and offers pelvic floor treatment without surgery, injections or internal treatment.

But the strongest safety feature is not simply the technology.

It is knowing when to use it and when not to.

At ¹EM, the objective is to identify contraindications, understand what is causing your symptoms and make sure pelvic floor strengthening is appropriate before treatment begins.

If urinary leakage, pelvic floor weakness, postpartum changes, post-prostate symptoms or another pelvic-health concern is affecting you, start with an individual assessment.

The ¹EM team can review your symptoms and medical history, with Dr Emir providing clinical input where required before your treatment plan is confirmed.

CTA heading: Start With a Safe, Personalised Assessment

CTA description: Book a complimentary ¹EM consultation to discuss your symptoms, medical history and whether EMSELLA® is appropriate for you.

CTA button: Book Your Complimentary Consultation

Internal links:

EMSELLA® at ¹EM

Can EMSELLA® Help With Urinary Incontinence?

Does EMSELLA® Help Men as Well?

Can I Have EMSELLA® After Pregnancy or Birth?

Can EMSELLA® Support Men With Erectile Dysfunction?

Who May Not Be Suitable for EMSCULPT NEO or EMSELLA®?

What Happens During a ¹EM Consultation?

1. Therapeutic Goods Administration. ARTG 302821, BTL Medical Technologies Pty Ltd, Deep-tissue electromagnetic stimulation system, professional.

The TGA records ARTG 302821 as an active Class IIa medical device supplied by BTL Medical Technologies Pty Ltd and manufactured by BTL Industries Limited.

2. BTL Aesthetics Australia. EMSELLA® provider and patient information.

BTL Australia lists EMSELLA® under ARTG 302821 for pelvic floor strengthening across specified genitourinary indications. Its Australian safety information states that therapy should be stopped if uncomfortable pain occurs and should not be applied in patients with electronic or metal implants.

3. Samuels JB, Pezzella A, Berenholz J, et al. Safety and Efficacy of a Non-Invasive High-Intensity Focused Electromagnetic Field Device for Treatment of Urinary Incontinence and Enhancement of Quality of Life. Lasers in Surgery and Medicine.

Seventy-five women with stress, urge or mixed urinary incontinence underwent six HIFEM treatments following medical screening.

4. Is the High-Intensity Focused Electromagnetic Energy an Effective Treatment for Urinary Incontinence in Women? Therapeutics and Clinical Risk Management. PMID 39640007.

Thirty-five women received six EMSELLA® treatments twice weekly, with significant improvements in urinary incontinence measures reported.

5. Leonardo K, Rahardjo HE, Afriansyah A. Noninvasive High-Intensity Focused Electromagnetic Therapy in Women With Urinary Incontinence: A Systematic Review and Meta-Analysis. Neurourology and Urodynamics. 2025.

Seven studies were included. Most did not highlight a significant safety issue, although the authors noted heterogeneity and potential bias and recommended stronger future research.

6. Evaluating the Efficacy of High-Intensity Focused Electromagnetic Therapy for Postprostatectomy Incontinence in Men. 2025. PMID 40909763.

Twenty-seven men received six EMSELLA® sessions following prostatectomy. Improvements in urinary symptoms and pad use were reported, with no adverse events observed during the study.

7. Silantyeva E, et al. A Comparative Study on the Effects of High-Intensity Focused Electromagnetic Technology and Electrostimulation for the Treatment of Pelvic Floor Muscles and Urinary Incontinence in Parous Women.

The study's screening criteria excluded pregnancy, pacemakers and metallic implants involving areas including the pelvis and hips, illustrating the importance of appropriate patient selection.

This article provides general health information and does not determine whether EMSELLA® is safe or appropriate for an individual patient. Relevant medical conditions, pregnancy, previous surgery and implanted electronic or metallic devices must be disclosed before treatment. Individual clinical assessment and applicable device contraindications take precedence over general information online.