Summary Safety Review - Single Incision Mini-sling - Assessing the Long-term (beyond 3 years) Safety and Effectiveness

Review decision

A Summary Safety Review complements other safety related information to help Canadians make informed decisions about their use of health products. Each summary outlines what was assessed in Health Canada’s review, what was found and what action was taken by Health Canada, if any.


Issued: 2020-09-18

Product

Single incision mini-sling (SIMS) made from non-absorbable synthetic material (polypropylene)

Potential Safety Issue

Safety and effectiveness beyond 3 years (long term)

Key Messages

  • In Canada, single incision mini-slings (SIMS) are medical devices used to treat stress urinary incontinence (SUI), or the accidental leaking of urine during physical activity, in women.
  • Health Canada reviewed the long-term (beyond 3 years) safety and effectiveness of SIMS used to treat SUI. This was a follow-up to reviews completed in 2009, 2013, and 2014 assessing various complications related to the use of SIMS and similar devices.
  • Given the lack of high-quality post-market information, Health Canada has asked SIMS' manufacturers for additional information related to the long-term safety and effectiveness.
  • The department will review the information within one year.

Overview

Health Canada reviewed the available post-market evidence to assess the long-term safety and effectiveness of SIMS used to treat SUI.

Health Canada is aware of various complications related to SIMS and other surgical meshes used to treat SUI since 2009. Prior to this safety review, Health Canada completed 3 safety reviews related to these devices and communicated on the safety issues.1,2,3

In 2014, information on the complications related to the use of these devices was added to the device label.

Use in Canada

  • In Canada, SIMS used to treat SUI in women are Class III medical devices, the second highest risk class of medical device.
  • SIMS are made from non-absorbable synthetic material and are intended as a permanent implant.
  • At the time of this safety review, there were 2 SIMS devices licensed for sale in Canada for the treatment of SUI:
    • Solyx Single Incision Sling System manufactured by Boston Scientific Corp.; and
    • Altis Single Incision Sling System manufactured by Coloplast A/S.
  • The number of sales of SIMS is small and medical professional associations have indicated that their use is very limited in Canada.

Safety Review Findings

  • Health Canada's review assessed updated reports of problems from Canada, newly published literature, clinical guidelines4,5,6,7 and experiences regarding the use of SIMS, as well as information issued by international regulatory agencies. Some regulatory actions taken by international partners include:
    • In 2017, the Australian Therapeutic Goods Administration removed all SIMS devices from the market.
    • In 2018, the United Kingdom Department of Health and Social Care "paused" the use of all SIMS devices.
    • SIMS remain on the market in other jurisdictions, including the United States.
  • Following the review completed in 2014, Health Canada received 20 Canadian incident reportsa linked with the use of SIMS manufactured by Boston Scientific Corp. and Coloplast A/S. These reports describe adverse events of pain, wearing away of tissues, repeated infections, problems with the way the bladder holds and releases urine (urinary dysfunction), pain when having sex (dyspareunia), organ damage, and bleeding. The information in these reports is in line with what has previously been reported for this type of device. Some of the complications may require additional surgery to remove the part of or the entire sling. Even with multiple surgical procedures, it may not always be possible to correct some of the complications.
  • Health Canada's review also found that the level of experience of surgeons plays an important role in the success of procedures involving SIMS for the treatment of SUI.4,5 Studies have shown that lower rates of reoperation for mesh revision or removal have been associated with procedures performed by experienced and high-volume surgeons.8 Canadian medical professional organizations recommend that surgeons participating in the treatment of female SUI using synthetic slings of any type should receive proper training, have performed an adequate volume of surgeries, and be experienced in the evaluation and management of complications.
  • The safety review found that there is not enough high-quality post-market information to assess long-term safety and effectiveness of SIMS to treat SUI in women.

Conclusions and actions

  • Health Canada's review could not make conclusions about the long-term safety and effectiveness of SIMS for the treatment of SUI due to lack of high quality post-market information.
  • Health Canada has asked for additional long-term post-market safety and effectiveness information, including clinical data from the literature and ongoing clinical studies, from the manufacturers of SIMS.
  • Health Canada plans to review SIMS within one year, taking into account the new additional long-term post-market safety and effectiveness information provided by the SIMS' manufacturers.

Additional information

The analysis that contributed to this safety review included scientific and medical literature, Canadian and international incident reports, clinical consultation, and what is known about the use of these medical devices both in Canada and internationally.

For additional information about Health Canada's assessment of medical devices, contact the Medical Devices Directorate (hc.meddevices-instrumentsmed.sc@canada.ca).

References

  1. Surgical Mesh - Complications associated with transvaginal implantation for the treatment of stress urinary incontinence and pelvic organ prolapse - Notice to Hospitals.
  2. Information regarding the transvaginal implantation of surgical mesh devices for the treatment of pelvic organ prolapse and stress urinary incontinence.
  3. Surgical Mesh - Complications associated with transvaginal implantation of surgical mesh for the treatment of stress urinary incontinence and pelvic organ prolapse.
  4. Welk B, Carlson K, Baverstock RJ, et al. Canadian Urological Association position statement on the use of transvaginal mesh. Canadian Urological Association Journal. 2017 Jun; 11(6Suppl2):S105-S107. [PMC]
  5. Surgical Treatment of Female Stress Urinary Incontinence (SUI): AUA/SUFU Guideline (2017). American Urological Association aunet.org. Published 2017. Accessed July 14, 2020.
  6. Urinary incontinence and pelvic organ prolapse in women: management. nice.org.uk. Published April 02, 2019. Updated June 24, 2019. Accessed July 14, 2020
  7. Chapple, CR, Cruz F, Deffieux X, et al. Consensus Statement of the European Urology Association and the European Urogynaecological Association on the Use of Implanted Materials for Treating Pelvic Organ Prolapse and Stress Urinary Incontinence. Eur Urol. 2017 Sep;72(3):424-431 doi: 10.1016/j.eururo.2017.03.048. Epub 2017 Apr 14. [Pubmed]
  8. Berger AA, Tan-Kim J, Menefee SA. Long-term Risk of Reoperation After Synthetic Mesh Midurethral Sling Surgery for Stress Urinary Incontinence. Obstet Gynecol. 2019 Nov;134(5):1047-1055. doi: 10.1097/AOG.0000000000003526. [Pubmed]

Footnotes

  1. Canadian reports can be accessed through the Canada Vigilance Online Database.

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