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.
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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.
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Cornelis R. C. Hogewoning and Lieke Gietelink contributed equally to manuscript
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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
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DOI: https://doi.org/10.1007/s00192-014-2488-5