Erratum to: Int Urogynecol J. 2015 Feb;26(2):229–34

DOI: 10.1007/s00192-014-2488-5. Epub 2014 Aug 21

The idea for this study originated in 2012 and aimed to check the availability of company databases on mid-urethral slings. Due to the lack of reactions and data provided by the involved companies, we decided to perform an additional literature search via PubMed to identify available pre-launch data. In this secondary search the FDA or EU date of approval (whichever was earlier) was used as introduction date. The final results of this search were sent to every company involved for verification. Since the publication of our paper however, relevant information has become available on two tapes of which we stated that no pre-launch data was available; the TFS and the I-Stop.

The TFS is produced by TFS Surgical (Allenby Gardens, Australia) and received its FDA approval in May 2005 based on a 510 k declaration of substantial equivalence. Following the publication of our article, information was received that the TFS was in fact under review for 5 years (2004–2009) and not commercialized on the date that the FDA approval suggested. During this period the TFS was deliberately withheld from the commercial market and multiple studies were conducted and published in various peer-reviewed magazines [2–6].

The second sling, the I-Stop by CL-medical (Sainte-Foy-Lès-Lyon, France), was CE-approved during the last quarter of 2002 after a pre-launch case series of 50 patients (not published). Upon approval, the tape had a targeted launch with a limited number of surgeons willing to participate in the clinical evaluation of the sling. The clinical evaluation was then presented as a poster at the National Congress of the French Association of Urology (AFU) in November 2003 and published as an article in the French magazine ‘Endomag’ in June 2004 (both not available on Pubmed). The first paper available on Pubmed was published in September 2004 in the journal European Urology [1].

Summarizing, the I-Stop was commercially available on the European market from the last quarter of 2002 to November 2003, without any available pre-launch data. However, during this first year the company did restrict the export of the sling to a limited number of specialists.

With this relevant new data available, table 3 of our article is incomplete. Although we feel that companies should provide an insight into their databases upon request, we realize that by stating a systematic review was performed, we, and not the companies involved, are ultimately responsible for data collection. We therefore apologize for these errors and any issues arising from them. Nonetheless, the conclusion of our article remains unchanged: mid-urethral slings are most often introduced without any scientifically proven basis or pre-launch research.