Who May Not Be Suitable for EMSCULPT NEO or EMSELLA?

EMSCULPT NEO and EMSELLA are non-invasive, but they are not suitable for everyone.

Tell the team about the exact implant or procedure, relevant dates and any manufacturer instructions you have. Treatment suitability is checked against the device being used and the proposed treatment area. A general online explanation cannot override a contraindication in the relevant instructions for use.

Can I Have EMSELLA After Pregnancy or Childbirth? · Can I Have EMSELLA After Prostate Surgery? · Can EMSELLA be considered after prolapse or anti-incontinence surgery?

Because both technologies use high-intensity electromagnetic fields, certain implanted electronic devices, pregnancy and some medical conditions can make treatment inappropriate. EMSCULPT NEO also incorporates radiofrequency energy, which adds its own safety considerations.

At ¹EM, suitability is assessed before treatment begins.

Some circumstances are clear contraindications. Others require Dr Emir to establish exactly what device, implant, medical condition or previous procedure is involved before deciding whether the proposed treatment can safely proceed.

No. A cardiac pacemaker is considered a contraindication to electromagnetic treatment such as EMSCULPT NEO and EMSELLA.

The electromagnetic fields generated during treatment can potentially interfere with active implanted electronic devices.

The US Food and Drug Administration specifically advises that magnetic-field body treatment devices should not be used in people with active implants such as:

Interference between electromagnetic fields and implanted cardiac devices is a recognised safety concern.

If you have a pacemaker, please tell the ¹EM team when you enquire.

We would not proceed with EMSCULPT NEO or EMSELLA treatment simply because the pacemaker is distant from the proposed treatment area.

If you have another type of implanted electronic device rather than a pacemaker, tell us exactly what it is so it can be reviewed.

These also require particular caution.

Active electronic implants can potentially be affected by electromagnetic fields. FDA guidance advises against magnetic-field body treatment in people with active implanted devices, and clinical EMSELLA studies have commonly excluded patients with implanted electronic devices.

Examples include:

If you have any implanted electronic device, disclose it before your appointment.

Do not switch off, modify or alter an implanted medical device in an attempt to become eligible for treatment.

Possibly not. A metal implant requires individual clinical review before treatment can be considered.

This is not something an online answer, reception or a generic online questionnaire should approve remotely.

FDA guidance advises against magnetic-field body treatment in patients with metal beneath the skin and also identifies metal implants as a concern for radiofrequency body-contouring procedures.

However, the phrase "metal implant" covers many very different situations.

Examples include:

The location of the implant, its composition, the proposed treatment area and the specific device involved all matter.

EMSELLA clinical research has commonly excluded metal implants in or around the pelvis, hips and lumbosacral region. Some research protocols have separately allowed investigators to evaluate other implants individually.

Treatment is not automatically approved.

Dr Emir may need to review:

A physical examination may also be required.

The purpose of this review is to establish whether your particular situation falls within a treatment contraindication.

Clinical assessment does not override manufacturer or device safety restrictions.

If the implant makes treatment contraindicated, ¹EM will not proceed.

Do not assume so.

Whether an implant is ferromagnetic is only one consideration.

Electromagnetic and radiofrequency treatments involve different physical interactions with tissue and implanted materials. The safe approach is therefore to identify the actual implant and assess it against the treatment technology and manufacturer restrictions rather than relying on the general statement that something is "titanium".

Bring any implant card, operative report or other identifying information you have.

If you do not have the records, the ¹EM team may ask you to obtain further information before treatment.

Tell us before booking treatment.

The answer can depend on both the treatment being considered and the location of the prosthesis.

This is particularly relevant for EMSELLA because the electromagnetic treatment field is centred around the pelvis. Published EMSELLA studies have excluded patients with metallic implants involving the pelvis or hip region.

The presence of a joint replacement should therefore be reviewed rather than assumed to be acceptable.

Tell the team exactly what type of IUD you have.

Some intrauterine devices contain metal, including copper-containing IUDs. EMSELLA clinical studies have excluded participants with IUDs containing metallic components.

Do not have an IUD removed simply for the purpose of pursuing treatment without first discussing contraception and the medical implications with the clinician responsible for your reproductive healthcare.

At ¹EM, the first step is simply identifying the device and reviewing suitability.

No. We do not perform EMSCULPT NEO or EMSELLA treatment during pregnancy.

Pregnancy has been an exclusion criterion in clinical research involving high-intensity focused electromagnetic treatment, including EMSELLA studies, and FDA guidance specifically advises patients to disclose pregnancy when considering non-invasive body treatments.

Treatment can be reconsidered after pregnancy when it is medically appropriate.

Tell us before treatment.

If there is a reasonable possibility of pregnancy, treatment should be deferred until pregnancy status has been clarified.

There is no benefit in taking an unnecessary risk for an elective treatment.

Potentially, but postpartum treatment is different from treatment during pregnancy.

EMSELLA can be relevant to selected patients experiencing pelvic floor weakness following childbirth, and ¹EM does treat postpartum pelvic health concerns.

However, treatment should not simply begin because pregnancy has ended.

Timing depends on factors such as:

Published EMSELLA research in postpartum women has generally used defined eligibility criteria rather than treating women immediately after delivery. One comparative study, for example, included women whose childbirth had occurred at least six months previously.

Your individual timing can be discussed during consultation.

Learn more about EMSELLA at ¹EM

There are other circumstances in which treatment may need to be avoided, delayed or reviewed medically before proceeding.

These can include relevant:

FDA guidance recommends that people considering non-invasive body-contouring treatments disclose medications, implanted devices, previous surgery, active infections, bleeding disorders, immune suppression, malignancy and pregnancy, among other relevant medical issues.

Not every item on that list automatically excludes every treatment.

It means the information matters.

Recent surgery can be important for several reasons.

EMSCULPT NEO produces powerful involuntary contractions in the muscles being treated, while EMSELLA produces repeated pelvic floor contractions.

If tissues are still healing, those contractions may be inappropriate.

The location and type of surgery, the time since surgery and your recovery therefore need to be considered before treatment.

If you have had a recent operation, tell us what procedure you had and when.

Cancer history should be disclosed before treatment.

Active malignancy, current cancer treatment and the anatomical relationship between the cancer and proposed treatment area can materially affect suitability.

A previous cancer diagnosis requires individual clinical review rather than an automatic online suitability decision.

It requires appropriate medical assessment.

Tell us.

Anticoagulation does not belong in the same category as a pacemaker, but it is clinically relevant information and should form part of your medical assessment.

Do not stop prescribed anticoagulant medication to undergo an elective treatment unless the clinician who manages that medication specifically instructs you to do so.

That is exactly why ¹EM uses a doctor-led assessment model.

You do not need to work out the answer yourself.

When appropriate, Dr Emir can review:

Additional information can be requested before a final decision is made.

We tell you.

A consultation is useful even if the final answer is that treatment should not proceed.

¹EM does not consider someone a good candidate simply because they would like to purchase treatment.

The first responsibility is determining whether treatment is appropriate.

No. Pacemakers are active electronic implants and are considered a contraindication to magnetic-field body treatments.

No. EMSELLA uses a high-intensity electromagnetic field and should not be used in patients with pacemakers.

Possibly not. Do not assume either way. Provide details of the implant so Dr Emir can determine whether the proposed treatment is permissible and appropriate.

A metallic hip implant is particularly relevant because of its proximity to the EMSELLA treatment field. It requires clinical review and may make treatment unsuitable.

A copper-containing IUD contains metal and must be disclosed. Published EMSELLA studies have excluded metallic IUDs. Treatment should not proceed until your individual situation has been reviewed.

No.

No.

No.

Our online assistant can explain general contraindications, but implant-specific treatment clearance is a clinical decision.

The ¹EM team may ask for additional information before Dr Emir determines whether treatment can proceed.

If available, bring your implant card, operative report, manufacturer details or other documentation identifying the device.

Do not worry if you do not have them immediately. Tell us what you know and we can explain what further information may be required.

Tell us.

It is much better to disclose an implant, previous operation, medication or medical condition and discover that it is irrelevant than to leave out something that could affect treatment safety.

1. US Food and Drug Administration. Non-Invasive Body Contouring Technologies. FDA guidance describes risks and contraindications associated with radiofrequency and magnetic-field body treatments, including active implanted devices and metal beneath the skin.

2. US Food and Drug Administration. Electronic Muscle Stimulators. The FDA notes reports of interference between muscle stimulation devices and implanted devices such as pacemakers and defibrillators.

3. ClinicalTrials.gov. EMSELLA Chair Versus Sham for Chronic Pelvic Pain. Trial eligibility criteria included detailed exclusions for major metallic and electronic implants, with investigator assessment of some other implants.

4. Silantyeva E, et al. Comparative HIFEM and electrostimulation study in parous women. Participants with pelvic, hip or lumbosacral metallic implants, metallic IUDs, pacemakers and pregnancy were excluded.

This article provides general information about treatment screening and does not determine your individual suitability. Do not rely on an online article or AI assistant to clear an implanted medical device for electromagnetic or radiofrequency treatment. Individual assessment and applicable device safety requirements take precedence.