Bulletins

Vaginal mesh implant surgery

April 20, 2017

These implants are used to treat conditions such as pelvic organ prolapse and stress urinary incontinence and have been around since 1996 when the first transvaginal mesh device was approved for use in cases of stress urinary incontinence (SUI). However, it was not until 2002 that the first transvaginal mesh was approved for use in cases of pelvic organ prolapse (POP). The actual product has been around for much longer, since the 1950s when it was originally used in hernia repairs, before being developed in the 1970s to treat POP and SUI abdominally.

In 2016 the American Agency, the FDA, upgraded the transvaginal mesh used in pelvic organ prolapse from Class II to Class III, which is a high risk category following safety concerns arising following use of the product.  Regulatory control of the product increases with each new classification. There are currently a number of studies in the UK being conducted into the product and updated guidance was issued by the National Institute for Health and Clinical Excellence in August 2016. The Scottish Government has even asked the NHS to consider suspending procedures using the transvaginal mesh until they have completed their Independent Review into the complications that have arisen following these surgeries.

There are 4 types of transvaginal mesh:

  • Non-Absorbable synthetic

A permanent implant

  • Absorbable synthetic

The mesh loses strength and degrades over time, eventually absorbed by the body

  • Biologic

Made from animal tissue, usually cow or pig, which also degrades over time

  • Composite

A combination of the above, non-absorbable synthetic, absorbable synthetic or biologic mesh

According to the NHS around 1,500 surgeries involving vaginal mesh implants are done in the UK every year and many women respond well.  However, as the recent news stories suggest, many people do suffer from complications, such as:

  • Perforation
  • Detachment of the device
  • Erosion of the bladder, vagina, urethra, ureter or bowel
  • Pain, discomfort and irritation
  • Nerve damage
  • Infections
  • Bleeding
  • Problems with sex life

Whilst not all of the complications listed are necessarily caused by negligence, some may arise from the surgery itself being carried out at a substandard level or even product failure.  In some cases, the potential risks associated with the implants may not have been adequately discussed.

The medical negligence team here at Metcalfes specialise in all areas of medical negligence.   If you or a loved one has been affected by problems arising from transvaginal mesh implants we can advise you on whether you have a claim.  We offer support and are here to sensitively guide you through your potential case.    If you would like to speak to us about this or any other matter, please contact us on 0117 239 8012.  Alternatively, you can email us by using our online contact form.

Further Reading:

https://www.nice.org.uk/guidance/ipg267

https://www.gov.uk/government/publications/use-safety-and-efficacy-of-transvaginal-mesh-implants-in-the-treatment-of-stress-urinary-incontinence-and-pelvic-organ-prolapse-in-women

Website content note: This is not legal advice; it is intended to provide information of general interest about current legal issues.

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Vaginal mesh implant surgery

Gillian Clark

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