Doctors 'Not Told About Full Risk Of Vaginal Mesh Implants'

BBC Panorama investigation also found pharmaceutical giant Ethicon launched a product having only tested it on 31 women and a sheep


As many as one in 15 women required full or partial removal of the vaginal mesh implant.

One of the world’s largest pharmaceutical companies failed to update doctors on the full extent of risks posed by vaginal mesh implants, an investigation by Panorama has found.

Known as trans-vaginal tape (TVT), the implant is a small mesh support that is used to treat urinary incontinence or prolapse occurring after childbirth. For the majority of women the procedure is quick and successful, however some patients have suffered debilitating complications such as severe pelvic pain, the mesh eroding through the vaginal wall or perforating organs.

As many as one in 15 women later require full or partial removal of the implant, with the latest figures showing that there have been more than 6,000 procedures to remove or partially remove mesh implants between 2006-07 and 2016-17, according to figures from NHS Digital and NHS Wales.

The BBC programme, which aired on Monday night, claimed that an in-house doctor of Ethicon, wholly owned by Johnson & Johnson, had not updated its information on complications caused by its Gynecare TVT mesh product.

The investigation also claimed that Ethicon launched a mesh implant product – the TVT-Secur implant – after testing it only in 31 women for five weeks, and in sheep. It was withdrawn in 2012 after six years on the market.

Panorama obtained emails from inside Ethicon, including one from the company’s associate medical director in 2008 who wrote to managers concerned that the information provided by Ethicon to surgeons about the Gynecare TVT mesh had not been updated since 2005.

She said “post-market knowledge” had provided much more information than was given to doctors and recommended updating the “potential adverse reactions” section of the implant’s instruction for use (IFU) document.

However, in January 2009 she wrote again to say this update had not been done and the document still referred to several complications as “transitory”, adding: “From what I see each day, these patient experiences are not ‘transitory’ at all.”

Ethicon admit they did not remove the word “transitory” at the time, however the company’s latest IFUs, updated in 2015, do make clear some effects may be permanent.

A spokeswoman for Ethicon told the programme: “The risks associated with the use of a permanent mesh implant were properly identified in Ethicon’s instructions for use.”

She added: “While we empathise with those who have experienced complications, the vast majority of women with pelvic mesh see an improvement in their day-to-day lives. All surgical pelvic floor procedures – with and without mesh – come with the risk of developing complications.”

Earlier in December, medical experts from University of Oxford warned that women have been exposed to unnecessary harm due to poor regulation for vaginal mesh products.

Prof Carl Heneghan, at Oxford’s Centre for Evidence-Based Medicine, who also featured on the Panorama programme, told the Guardian: “Many women have been subjected to great harm because regulatory loopholes allowed mesh devices to be made available in large numbers with no evidence in humans. It is now clear that regulation is not fit for purpose for the riskiest of devices, those that are implanted in the body.

“We now know that women who received mesh implants have been part of a global experiment that in many cases has gone badly wrong.”

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