Long-term Experience of Magnetic Anal Sphincter Augmentation in Patients With Fecal Incontinence

Sugrue, Jeremy; Lehur, P.‐A.; Madoff, Robert D.; McNevin, Shane; Buntzen, Steen; Laurberg, Søren; Mellgren, Anders

doi:10.1097/dcr.0000000000000709

Cited by 40 publications

(17 citation statements)

References 22 publications

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“…There were also attempts to treat faecal incontinence surgically by implanting magnetic anal sphincter device [23]. As previously mentioned, D'Addio et al have reported promising results of their current studies on anti-TMEM219 monoclonal antibody (IGFBP3 receptor present in intestinal crypts), both in in vitro and in vivo and in a mouse model [10].…”

Section: Treatmentmentioning

confidence: 79%

Diabetic enteropathy — still undefeated?

Tomaszewska¹,

Mrozikiewicz-Rakowska²,

Czupryniak³

2017

Clinical Diabetology

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Section: Treatmentmentioning

confidence: 79%

Diabetic enteropathy — still undefeated?

Tomaszewska¹,

Mrozikiewicz-Rakowska²,

Czupryniak³

2017

Clinical Diabetology

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“…Pakravan et al 46 reported a success rate of 76% in 18 patients undergoing FENIX implantation, defined as a ≥ 50% reduction in FI rates per week, with no explants. In a longer-term study, Sugrue et al 47 reported on 37 FENIX patients with a median follow-up of 5 years. Therapeutic success rates at 1, 3 and 5 years were 63%, 66% and 53%, respectively.…”

Section: Chapter 4 Discussionmentioning

confidence: 99%

Sacral nerve stimulation versus the magnetic sphincter augmentation device for adult faecal incontinence: the SaFaRI RCT

Jayne

Williams

Corrigan

et al. 2021

Health Technol Assess

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Background Preliminary studies using the FENIX™ (Torax Medical, Minneapolis, MN, USA) magnetic sphincter augmentation device suggest that it is safe to use for the treatment of adult faecal incontinence, but efficacy data are limited. Objective To compare FENIX with sacral nerve stimulation for the treatment of adult faecal incontinence in terms of safety, efficacy, quality of life and cost-effectiveness. Design, setting and participants Multicentre, parallel-group, unblinded, randomised trial comparing FENIX with sacral nerve stimulation in participants suffering moderate to severe faecal incontinence. Interventions Participants were randomised on an equal basis to either sacral nerve stimulation or FENIX. Follow-up occurred 2 weeks postoperatively and at 6, 12 and 18 months post randomisation. Main outcome and measure The primary outcome was success, defined as device in use and ≥ 50% improvement in Cleveland Clinic Incontinence Score at 18 months post randomisation. Secondary outcomes included complication rates, quality of life and cost-effectiveness. Between 30 October 2014 and 23 March 2017, 99 participants were randomised across 18 NHS sites (50 participants to FENIX vs. 49 participants to sacral nerve stimulation). The median time from randomisation to FENIX implantation was 57.0 days (range 4.0–416.0 days), and the median time from randomisation to permanent sacral nerve stimulation was 371.0 days (range 86.0–918.0 days). A total of 45 out of 50 participants underwent FENIX implantation and 29 out of 49 participants continued to permanent sacral nerve stimulation. The following results are reported, excluding participants for whom the corresponding outcome was not evaluable. Overall, there was success for 10 out of 80 (12.5%) participants, with no statistically significant difference between the two groups [FENIX 6/41 (14.6%) participants vs. sacral nerve stimulation 4/39 (10.3%) participants]. At least one postoperative complication was experienced by 33 out of 45 (73.3%) participants in the FENIX group and 9 out of 40 (22.5%) participants in the sacral nerve stimulation group. A total of 15 out of 50 (30%) participants in the FENIX group ultimately had to have their device explanted. Slightly higher costs and quality-adjusted life-years (incremental = £305.50 and 0.005, respectively) were observed in the FENIX group than in the sacral nerve stimulation group. This was reversed over the lifetime horizon (incremental = –£1306 and –0.23 for costs and quality-adjusted life-years, respectively), when sacral nerve stimulation was the optimal option (net monetary benefit = –£3283), with only a 45% chance of FENIX being cost-effective. Limitations The SaFaRI study was terminated in 2017, having recruited 99 participants of the target sample size of 350 participants. The study is, therefore, substantially underpowered to detect differences between the treatment groups, with significant uncertainty in the cost-effectiveness analysis. Conclusions The SaFaRI study revealed inefficiencies in the treatment pathways for faecal incontinence, particularly for sacral nerve stimulation. The success of both FENIX and sacral nerve stimulation was much lower than previously reported, with high postoperative morbidity in the FENIX group. Future work Further research is needed to clarify the treatment pathways for sacral nerve stimulation and to determine its true clinical and cost-effectiveness. Trial registration Current Controlled Trials ISRCTN16077538. Funding This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 25, No. 18. See the NIHR Journals Library website for further project information.

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“…62 Other groups found similar success with the magnetic sphincter with comparative results with the artificial bowel sphincter and sacral neuromodulation. [63][64][65][66] In April 2017, the manufacturers (Torax and Ethicon) discontinued sales and studies for the device based on the company's business plans. 67 TOPAS Sling (American Medical Systems)…”

Section: Magnetic Sphincter (Fenix Torax Medical)mentioning

confidence: 99%

Surgical Treatment Alternatives to Sacral Neuromodulation for Fecal Incontinence: Injectables, Sphincter Repair, and Colostomy

Ivatury

Wilson

Paquette

2021

Clin Colon Rectal Surg

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Long-term Experience of Magnetic Anal Sphincter Augmentation in Patients With Fecal Incontinence

Abstract: Magnetic anal sphincter augmentation provided excellent outcomes in patients who retained a functioning device at long-term follow-up. Protocols to reduce early complications will be important to improve overall results.

Cited by 40 publications

References 22 publications

Diabetic enteropathy — still undefeated?

Diabetic enteropathy — still undefeated?

Sacral nerve stimulation versus the magnetic sphincter augmentation device for adult faecal incontinence: the SaFaRI RCT

Surgical Treatment Alternatives to Sacral Neuromodulation for Fecal Incontinence: Injectables, Sphincter Repair, and Colostomy

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