The results of the LIPLEG trial were published in The Lancet on 4 September 2026, adding a major new body of evidence to the debate around liposuction for lipoedema.

Although the research was carried out in Germany, its publication has clear implications for lipoedema treatment in England. NICE currently recommends that liposuction for chronic lipoedema should only be undertaken in the context of research, and has committed to reviewing its guidance when the LIPLEG evidence becomes available.

The publication therefore raises an important question for women with lipoedema in England: how might this new evidence affect the future assessment of liposuction by NICE and, ultimately, access to treatment?

What was the LIPLEG trial?

LIPLEG was the world’s first multicentre randomised controlled trial to directly compare liposuction with conservative treatment for lipoedema.

The trial was commissioned in Germany by the Gemeinsamer Bundesausschuss (G-BA), the Federal Joint Committee responsible for determining which treatments are provided through German statutory health insurance.

The process began in March 2014, when patient representatives applied to the G-BA for an assessment of liposuction for lipoedema. In May that year, the G-BA agreed to assess the procedure.

By July 2017, the G-BA had concluded that the available evidence was insufficient to determine the benefit of liposuction with the certainty required for routine provision. Rather than concluding that the treatment did not work, it suspended its assessment and initiated a formal trial under the German system for evaluating treatments where there is potential benefit but insufficient evidence.

The framework for the LIPLEG trial was agreed in January 2018 and came into force in April. In April 2019, the G-BA commissioned the Centre for Clinical Trials at the University of Cologne, working with the Department of Dermatology at Klinikum Darmstadt, to undertake the scientific management and evaluation of the study.

Recruitment began in early 2021.

Liposuction had already been used to treat lipoedema for many years, and a number of observational studies had reported reductions in pain and improvements in quality of life following surgery. What had been missing was a large prospective randomised study directly comparing surgery with conservative treatment.

LIPLEG was designed specifically to address that evidence gap in women with stage I, II and III lipoedema.

How was the LIPLEG trial conducted?

LIPLEG was conducted across 11 study centres in Germany.

Between 19 January 2021 and 7 June 2022, 1,973 women were screened. Of these, 453 entered the study and 410 women were randomised. The mean age of the randomised participants was 42.9 years.

All had confirmed stage I, II or III lipoedema affecting the legs and clinically significant leg pain. Participants received conservative treatment for up to seven months before randomisation.

The 410 women were then randomised in a 2:1 ratio:

• 278 women were allocated to liposuction.
• 132 women continued with conservative treatment.

Randomisation was stratified by both lipoedema stage and study centre.

The study used an intention-to-treat analysis, meaning that all 410 randomised women were included in the primary analysis according to the treatment group to which they had originally been assigned.

It is clearly impossible to blind a woman to whether or not she has undergone liposuction. Instead, LIPLEG used investigator-blinded assessment. Patches were applied to participants’ legs to help conceal evidence of surgery during assessments, and women were instructed not to disclose their treatment allocation to the assessor.

This design allowed liposuction to be compared directly with ongoing conservative management rather than simply measuring women before and after surgery.

What did the LIPLEG trial measure?

The primary outcome was leg pain at 12 months.

A successful response was defined in advance as a reduction of at least 2 points on a 0–10 numerical pain rating scale. Where the 12-month assessment was missing, the participant was counted as not having achieved the primary outcome.

The study also examined a broad range of secondary outcomes, including physical function, movement restriction, health-related quality of life, depressive symptoms, bruising, oedema, leg circumference, body fat percentage and the amount of physical therapy required.

Adverse events and serious adverse events were also recorded.

The results published in The Lancet report the 12-month randomised comparison. Further observational follow-up is intended to provide additional information on longer-term outcomes, including the effects of repeat interventions.

What did the LIPLEG trial find?

The difference between the two treatment groups was substantial.

At 12 months, 190 of the 278 women allocated to liposuction – 68.3% – achieved a reduction of at least 2 points in leg pain.

In the conservative-treatment group, 10 of 132 women – 7.6% – achieved the same reduction.

The odds ratio was approximately 26.2 (95% CI 13.1–52.5), p<0.0001.

The differences extended beyond pain.

For l=Lower-Extremity Physical Function, measured using the Lower Extremity Functional Scale (LEFS), 70.0% of women in the liposuction group achieved the specified clinically relevant improvement, compared with 10.0% in the conservative-treatment group.

On the physical component of the SF-36 quality-of-life measure, 73.7% of women following liposuction achieved the specified improvement, compared with 13.4% receiving conservative treatment.

Improvements were also reported in mental health and depressive symptoms.

These findings differ from the evidence available before LIPLEG because the outcomes were produced within a prospective randomised comparison. Women undergoing surgery were compared at the same point in time with women continuing conservative treatment under the same trial protocol.

What did LIPLEG find about safety?

LIPLEG also provides prospective safety data, and adverse events were more frequent in the surgical group.

In the published safety population, 124 of 265 women (47%) in the liposuction group experienced adverse events, compared with 30 of 145 women (21%) in the conservative-treatment group.

Serious adverse events occurred in 20 of 265 women (8%) in the liposuction group and 5 of 145 women (3%) in the conservative-treatment group.

The safety-population denominators differ from the 278 and 132 women in the randomised groups because the safety analysis population was defined separately.

The authors concluded that liposuction was superior to conservative therapy in reducing leg pain and improving quality of life, but was associated with a higher rate of serious adverse events. Assessment of the potential benefits and surgical risks therefore remains part of individual treatment decision-making.

How did the LIPLEG trial change lipoedema treatment in Germany?

Germany did not wait for publication of the final paper in The Lancet before acting on the first LIPLEG results.

In September 2019, while LIPLEG was being prepared, the G-BA introduced temporary statutory health insurance coverage for liposuction for women with stage III lipoedema, subject to quality requirements. This arrangement was intended to provide access for this group while the evidence from LIPLEG was being collected.

The first 12-month trial data were subsequently assessed by the G-BA.

On 17 July 2025, it decided that liposuction for lipoedema should be included in the regular statutory health insurance benefit catalogue for stages I, II and III, subject to specified clinical and quality requirements.

The decision came into force on 9 October 2025.

German provision is not unrestricted. Before liposuction is indicated, medically prescribed conservative treatment must have been undertaken continuously during the preceding six months and must have failed to provide sufficient relief from symptoms.

The German requirements also address weight stability, obesity and appropriate patient selection. Conservative management includes compression and appropriate exercise or muscle strengthening under compression, with manual lymphatic drainage where clinically appropriate.

When the 12-month LIPLEG results were formally published in The Lancet in September 2026, the G-BA confirmed that these were the results it had already considered when making its 2025 decision.

What do NICE guidelines say about liposuction for lipoedema?

In England, the position is very different.

NICE published its guidance on liposuction for chronic lipoedema on 29 March 2022. Originally issued as IPG721, it has subsequently been transferred to HealthTech Guidance HTG618, without changing the recommendation.

NICE describes lipoedema as a condition distinct from obesity and lymphoedema, involving an abnormal and usually symmetrical accumulation of fat, most commonly affecting the legs, hips and buttocks and sometimes the arms.

It recognises the associated pain, bruising, mobility difficulties and effects on quality of life.

NICE also states that the abnormal fat associated with lipoedema is usually resistant to diet and exercise. Conservative management can include compression therapy and manual lymphatic drainage and may help to manage symptoms, but it does not remove the abnormal adipose tissue.

The principal surgical treatment is liposuction.

Despite this, NICE currently recommends that liposuction for chronic lipoedema should only be used in the context of research.

What evidence did NICE have in 2022?

The evidence NICE considered in reaching its recommendation was very different from the evidence now available from LIPLEG.

Its rapid evidence review included nine sources, eight of which were before-and-after studies.

These studies reported improvements in areas including pain, mobility, limb size, quality of life and reduced reliance on conservative treatment following liposuction. NICE nevertheless identified substantial methodological limitations in the evidence.

Most of the research was observational. There was no large randomised controlled trial directly comparing women receiving liposuction with women continuing conservative treatment.

NICE also considered 29 patient commentaries, most of which described positive experiences of treatment, and the committee recognised both the serious effects lipoedema can have on women and the limited treatment options available.

Safety remained an area of uncertainty. Concerns considered by NICE included complications such as fluid imbalance, fat embolism, deep-vein thrombosis and local anaesthetic toxicity.

NICE did not conclude that liposuction was ineffective. It concluded that the available evidence on efficacy and safety was inadequate in quality and quantity to support routine use.

Its recommendation was therefore that the procedure should only be performed in the context of research.

NICE already knew the LIPLEG trial was underway

LIPLEG was not an unknown future study when NICE produced its guidance.

The 2021 LIPLEG trial protocol was specifically identified in NICE’s evidence review as ongoing research.

NICE recorded the planned study as a multicentre randomised trial comparing tumescent liposuction with complex decongestive therapy, with an estimated sample of approximately 450 participants. It also identified the planned primary endpoint: a reduction of at least 2 points in pain at 12 months.

There were no LIPLEG outcome data available for NICE to include in its assessment in 2022 because the trial was still underway.

The NICE recommendation was therefore made against a background of limited observational evidence while a randomised trial designed to answer many of those outstanding questions was already in progress.

What has changed since the NICE guidance was published?

That trial has now reported.

NICE’s 2022 assessment did not have a large randomised comparison between liposuction and conservative treatment. There is now a trial involving 410 randomised women across 11 centres, including women with stage I, II and III disease.

Its primary endpoint showed clinically meaningful pain reduction in 68.3% of women allocated to liposuction compared with 7.6% receiving conservative treatment, alongside differences in physical function and quality of life.

LIPLEG has also provided prospectively collected safety data, including the higher incidence of adverse and serious adverse events in the surgical group.

Longer-term outcomes, repeat procedures and the balance between sustained benefit and surgical risk will continue to require assessment as further follow-up becomes available.

What could the LIPLEG trial mean for lipoedema treatment in England?

Publication of LIPLEG does not automatically alter the NICE recommendation, nor does the German decision determine what should be commissioned by the NHS.

NICE will assess the evidence according to its own processes and in the context of healthcare provision in England.

However, the evidential position has changed since the guidance was produced.

When NICE assessed liposuction for chronic lipoedema in 2022, it found promising outcomes but insufficient good-quality evidence to establish efficacy and safety. The large randomised controlled trial that NICE knew was underway has now produced its first published results.

NICE has committed to reviewing its guidance when the LIPLEG results are available and to considering whether the evidence supports a change in its recommendations.

Germany has already used the 12-month LIPLEG findings to extend statutory provision of liposuction from stage III disease to stages I, II and III, with eligibility and quality requirements.

That German decision does not mean that NICE will reach the same conclusion. It does, however, show how the results have already been interpreted by the healthcare system that commissioned the trial specifically to resolve uncertainty about the effectiveness of liposuction.

For women with lipoedema in England, publication of LIPLEG does not mean that NHS-funded liposuction will immediately become available. Services are commissioned within the NHS, and any change in access would depend on NICE’s assessment and subsequent commissioning decisions.

What has changed is the evidence available for that assessment.

The current NICE recommendation was made when there was no large randomised controlled trial directly comparing liposuction with conservative treatment. There now is.

References

Podda M, Schmidt J, Cornely ME, et al. (2026). Liposuction versus conservative therapy for patients with lipoedema in Germany: a multicentre, randomised controlled clinical trial. The Lancet, 408(10558), 910–923. doi:10.1016/S0140-6736(26)00910-4.

Podda M, Kovacs M, Hellmich M, Roth R, Zarrouk M, Kraus D, Prinz-Langenohl R, Cornely OA. (2021). A randomised controlled multicentre investigator-blinded clinical trial comparing efficacy and safety of surgery versus complex physical decongestive therapy for lipedema (LIPLEG). Trials, 22(1), 758. doi:10.1186/s13063-021-05727-2.

National Institute for Health and Care Excellence (NICE) (2022). Liposuction for chronic lipoedema. Interventional Procedures Guidance IPG721, subsequently migrated to HealthTech Guidance HTG618.

National Institute for Health and Care Excellence (NICE) (2022). Interventional procedure overview of liposuction for chronic lipoedema. Evidence review supporting IPG721/HTG618.

Gemeinsamer Bundesausschuss (G-BA) (2017). Liposuction for lipoedema: suspension of benefit assessment and initiation of a trial under §137e SGB V.

Gemeinsamer Bundesausschuss (G-BA) (2019). Liposuction for stage III lipoedema: temporary inclusion within statutory health insurance subject to quality requirements.

Gemeinsamer Bundesausschuss (G-BA) (2025). Liposuction for lipoedema: inclusion in the regular statutory health insurance benefit catalogue following positive benefit assessment. Decision of 17 July 2025.

Gemeinsamer Bundesausschuss (G-BA) (2026). LIPLEG study: publication of the 12-month randomised trial results in The Lancet. 4 September 2026.