The trial that launched millions of mesh implant procedures: did money compromise the outcome?BMJ 2018; 363 doi: https://doi.org/10.1136/bmj.k4155 (Published 10 October 2018) Cite this as: BMJ 2018;363:k4155
- Jonathan Gornall, investigative journalist, Suffolk, UK
In March 1997, Swedish obstetrician and gynaecologist Ulf Ulmsten received an offer he couldn’t refuse. A year earlier Ulmsten, the head of obstetrics and gynaecology at Uppsala University Hospital, had published a paper reporting the results of a revolutionary surgical procedure to treat stress urinary incontinence in women.
The standard surgical treatment at the time was colposuspension, a procedure little changed since it was first developed in 1959, in which the neck of the bladder is lifted, compressing the urethra, and sutured to the pelvic bone. It required open abdominal surgery and involved several days in hospital and lengthy recovery. By contrast, Ulmsten’s mid-urethral sling procedure, in which a narrow length of plastic mesh tape is inserted through the vagina to act as a sling, or hammock, to raise and support the urethra, could be done under local anaesthetic as an outpatient procedure.
A study of 75 women treated in Ulmsten’s department at Uppsala University Hospital with what became known as the tension-free vaginal tape (TVT) procedure gave impressive results—84% (63) of the women with stress incontinence were completely cured throughout a two year follow-up period, and another 8% (5) were “significantly improved.”1 The results suggested TVT was at least as successful as colposuspension in treating stress urinary incontinence,2 with the added benefits that patients could get back to their lives more quickly and surgeons could perform more and easier procedures at less cost to their hospitals.
Ulmsten, aware that his results might be considered, in his words, “too …