PIONEERING TREATMENT FOR INCONTINENCE USED ACROSS THE NHS RECEIVES APPROVAL FROM THE FDA
Contura (headquartered in London) is pleased to announce official notification from the Federal Drug Administration (“FDA”) that the premarket approval application (“PMA”) for Bulkamid® has been approved (January 2020) paving the way for its US launch within the next month.
Bulkamid®, a minimally invasive treatment which is already widely used across the UK’s NHS, is currently marketed in more than 25 countries throughout the world. It is Contura’s proprietary medical device and its approved indication in the US is for the treatment of stress urinary incontinence (“SUI”).
Commenting on its approval, London-based 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 it will soon 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, but this procedure, 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.[3, 4]
The Bulkamid® treatment (a soft hydrogel that consists of 97.5% water and 2.5% polyacrylamide) is increasingly being used in Europe and now represents the number one SUI treatment in the UK after conservative measures (such as specialist physiotherapy).
SUI is a common condition, affecting an estimated 30% of women worldwide. In the US, many hundreds of thousands of women are diagnosed with SUI annually but only a small proportion are treated. It can occur at any stage of life, with risk factors including pelvic disorders from pregnancy and childbirth, obesity, menopause and ageing.
Following news of the FDA approval, Contura is also announcing an imminent expansion of its operations into the US and will establish offices in Los Angeles early next month – signalling exciting times ahead for the UK and European commercial and manufacturing teams.
Pelvic floor specialist, Professor Roger Dmochowski, concludes: “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.”
- Itkonen Freitas et al. Tension-Free Vaginal Tape Surgery versus Polyacrylamide Hydrogel Injection for Primary Stress Urinary Incontinence: A Randomized Clinical Trial. J Urol. 2020 Feb;203(2):372-378.
- Fieldwork for the survey commissioned by Contura International, took place 1st – 4th December 2017, among 2,000 women, aged 18+
- Dwyer et al. “Voice your choice”: a study of women’s choice of surgery for primary stress urinary incontinence. Int Urogynecol J. 2019 Dec 18.
- Ong et al. Development, validation and initial evaluation of patient-decision aid (SUI-PDA©) for women considering stress urinary incontinence surgery. Int Urogynecol J. 2019 30:2013-2022