Abstract
Introduction and hypothesis
The objective of this study was to evaluate the degree and reliability of evidence used by manufacturers before the introduction of mid-urethral slings (MUS) onto the commercial market. Furthermore, minimum standards for marketed slings are recommended by evaluating recent suggestions for the introduction of gynecological meshes.
Methods
A systematic literature search was conducted using PubMed and commercial internet search engines in order to identify slings introduced by the industry over the last decade. Moreover, manufacturers were contacted by email, mail, and phone to provide data from before the introduction of the slings onto the commercial market. Once contact had been initiated, a 6-month deadline was set for data collection.
Results
Forty-one slings introduced between 1996 and 2012 were identified. Ten slings were described in a total of 20 studies with sample sizes varying from 10 to 368. The 41 MUS were produced by a total of 19 different companies. Seven companies never responded to recurrent emails, phone calls or other means of attempted contact. Thirty-one slings (76 %) remained without any comparative pre-launch data.
Conclusions
Mid-urethral slings were often introduced without any scientifically proven basis or pre-launch research. The US Food and Drug Administration and the European authorities should undertake immediate action by imposing strict rules before the launch of new MUS comparable with those recently suggested for meshes used in vaginal prolapse surgery.
Similar content being viewed by others
References
Ulmsten U, Henriksson L, Johnson P, Varhos G (1996) An ambulatory surgical procedure under local anesthesia for treatment of female urinary incontinence. Int Urogynecol J Pelvic Floor Dysfunct 7:81–85
Novara G, Ficarra V, Boscolo-Berto R, Secco S, Cavalleri S, Artibani W (2007) Tension-free midurethral slings in the treatment of female stress urinary incontinence: a systematic review and meta-analysis of randomized controlled trials of effectiveness. Eur Urol 52:663–678
Ogah J, Cody DJ, Rogerson L (2011) Minimally invasive synthetic suburethral sling operations for stress urinary incontinence in women: a short version Cochrane review. Neurourol Urodyn 30:284–291
Deval B, Ferchaux J, Berry R, Gambino S, Ciofu C, Rafii A, Haab F (2006) Objective and subjective cure rates after trans-obturator tape (OBTAPE) treatment of female urinary incontinence. Eur Urol 49:373–377
Hogewoning CR, Ruhe IM, Bekker MD, Hogewoning CJ, Putter H, DeRuiter MC, Pelger RC, Elzevier HW (2012) The MiniArc sling for female stress urinary incontinence: clinical results after 1-year follow-up. Int Urogynecol J 23:589–595
Abrams P, Chapple CR, Drake M, El-Neil S, Ludgate S, Smith AR (2011) Synthetic vaginal tapes for stress incontinence: proposals for improved regulation of new devices in Europe. Eur Urol 60:1207–1211
Davila GW (2012) Optimizing safety and appropriateness of graft use in pelvic reconstructive surgery: introduction to the 2nd IUGA Grafts Roundtable. Int Urogynecol J 23(Suppl 1):S3–S6
Slack M, Ostergard D, Cervigni M, Deprest J (2012) A standardized description of graft-containing meshes and recommended steps before the introduction of medical devices for prolapse surgery. Consensus of the 2nd IUGA Grafts Roundtable: optimizing safety and appropriateness of graft use in transvaginal pelvic reconstructive surgery. Int Urogynecol J 23 [Suppl 1]:S15–S26
de Leval J, Thomas A, Waltregny D (2011) The original versus a modified inside-out transobturator procedure: 1-year results of a prospective randomized trial. Int Urogynecol J 22:145–156
De Leval J (2003) Novel surgical technique for the treatment of female stress urinary incontinence: transobturator vaginal tape inside-out. Eur Urol 44:724–730
Deval B, Levardon M, Samain E, Rafii A, Cortesse A, Amarenco G, Ciofu C, Haab F (2003) A French multicenter clinical trial of SPARC for stress urinary incontinence. Eur Urol 44:254–258
Hinoul P, Bonnet P, Krofta L, Waltregny D, de Leval J (2011) An anatomic comparison of the original versus a modified inside-out transobturator procedure. Int Urogynecol J 22:997–1004
Palma P, Riccetto C, Reges R, Fraga R, Miyaoka R, Hermann V, Marcondes T (2008) Arcus to arcus microsling: technique and preliminary results. Int Urogynecol J Pelvic Floor Dysfunct 19:1133–1136
Palma PC, Riccetto CL, Dambros M, Thiel M, De FR, Tamanini JT, Herrmann V, Netto NR Jr, Grossi O, Zangone M, Paladini M, Retto H, Colaco J, Castro DD (2004) SAFYRE. A new concept for adjustable minimally invasive sling for female urinary stress incontinence. Actas Urol Esp 28:749–755
Palma PC, Dambros M, Riccetto CZ, Thiel M, Netto NR Jr (2005) The Ibero-American experience with a re-adjustable minimally invasive sling. BJU Int 95:341–345
Rogers RM, Lucente VR, Raders J L. Anatomic considerations for the TVT-Obturator approach for the correction of female stress urinary incontinence. 2004; 2004.
Sousa-Escandon A, Lema GJ, Rodriguez Gomez JI, Rios TL, Uribarri GC, Marques-Queimadelos A (2003) Externally readjustable device to regulate sling tension in stress urinary incontinence: preliminary results. J Endourol 17:515–521
Ulmsten U, Falconer C, Johnson P, Jomaa M, Lanner L, Nilsson CG, Olsson I (1998) A multicenter study of tension-free vaginal tape (TVT) for surgical treatment of stress urinary incontinence. Int Urogynecol J Pelvic Floor Dysfunct 9:210–213
Waltregny D, Reul O, Mathantu B, Gaspar Y, Bonnet P, de Leval J (2006) Inside out transobturator vaginal tape for the treatment of female stress urinary incontinence: interim results of a prospective study after a 1-year minimum followup. J Urol 175:2191–2195
Labrie J, Fischer K, van der Vaart CH (2012) Health-related quality of life. The effect of pelvic floor muscle training and midurethral sling surgery: a systematic review. Int Urogynecol J 23:1155–1162
Acknowledgement
We would like to thank L.C.L.M. Naves for carefully reading the manuscript.
Addendum
On 29 April 2014 the FDA released the following press announcement:
The U.S. Food and Drug Administration today issued two proposed orders to address the health risks associated with surgical mesh used for transvaginal repair of pelvic organ prolapse (POP). If finalized, the orders would reclassify surgical mesh for transvaginal POP from a moderate-risk device (class II) to a high-risk device (class III) and require manufacturers to submit a premarket approval (PMA) application for the agency to evaluate safety and effectiveness.
Although these two proposals do not include the MUS addressed in this study, the surgical mesh used for transvaginal POP repair is essentially the same material (polypropylene mesh) that is used for most MUS. These recent developments only further amplify our call for immediate action by the FDA and European authorities.
Conflicts of interest
None.
Author information
Authors and Affiliations
Corresponding author
Additional information
Cornelis R. C. Hogewoning and Lieke Gietelink contributed equally to manuscript
Rights and permissions
About this article
Cite this article
Hogewoning, C.R.C., Gietelink, L., Pelger, R.C.M. et al. The introduction of mid-urethral slings: an evaluation of literature. Int Urogynecol J 26, 229–234 (2015). https://doi.org/10.1007/s00192-014-2488-5
Received:
Accepted:
Published:
Issue Date:
DOI: https://doi.org/10.1007/s00192-014-2488-5