The Food and Drug Administration (FDA) has approved Contura’s Bulkamid device for the treatment of stress urinary incontinence (SUI).
The premarket approval had been approved, paving the way for its launch within the next month. The device is already widely used across the NHS, and is currently marketed in more than 25 countries throughout the world. The pivotal North American study reporting on the efficacy and safety of Bulkamid for the treatment of female stress incontinence formed the basis of Contura’s PMA.
Rakesh Tailor, director of Contura said: "We are extremely proud to have gained Bulkamid’s approval in the United States and we are particularly excited that Bulkamid will, in the coming weeks, be available to women suffering from symptoms that significantly affect their day to day lives. There is a degree of patient apprehension with the currently available treatments for SUI, and Bulkamid, with its excellent safety and effectiveness profile, supported by recent clinical data, is now a true first line alternative for those women.”
Consumer research carried out in the UK amongst 2,000 women on behalf of the educational Control Your Choice campaign showed almost half of those questioned (48%) admitted that stories reported extensively by the international media about potential side effects of TVT-tape or “mesh” (currently suspended in the UK) would deter them from seeking any advice from a health professional about treatment options for SUI.
It is now hoped that by extending the availability of a proven procedure with no serious side-effects will return “choice” to women suffering from this often-debilitating condition. And, the US approval comes on the back of recent evidence showing that when women with SUI are given a choice of treatments, their preferred option is now urethral bulking.
Following news of the FDA approval, Contura is also announcing an imminent expansion of its operations into the US and will establish its own US office in Los Angeles early next month.
Professor Roger Dmochowski, a pelvic floor specialist in Nashville, Tennessee said: “Given the currently available options for SUI, many women simply choose not to have treatment given the safety concerns that prevail. Bulkamid offers these women a new safe and effective option which probably represents the most innovative treatment for SUI to arrive in the US in the last 10+ years.”
