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.
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.
Authors: P C R Palma; C L Z Riccetto; M Dambros; M Thiel; R de Fraga; J T N Tamanini; V Herrmann; N R Netto; O Grossi; M Zangone; M Paladini; H Retto; J Colaço; D Castro Díaz Journal: Actas Urol Esp Date: 2004 Nov-Dec Impact factor: 0.994
Authors: C R C Hogewoning; I M C Ruhe; M D Bekker; C J A Hogewoning; H Putter; M C DeRuiter; R C M Pelger; H W Elzevier Journal: Int Urogynecol J Date: 2011-11-23 Impact factor: 2.894