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Ethicon Media Monitoring 1/30/2019
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Mesh study author failed to declare £100 000 from manufacturer
Jan 29, 2019 | British Medical Journal
By Gareth Lacobucci
A senior medical consultant and researcher has acknowledged that he failed to declare £100 000 received from the manufacturer of a type of vaginal mesh implant that he assessed in a 2012 study.
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Mesh study author failed to declare £100 000 from manufacturer
Jan 29, 2019 | British Medical Journal
By Gareth Lacobucci
A senior medical consultant and researcher has acknowledged that he failed to declare £100 000 received from the manufacturer of a type of vaginal mesh implant that he assessed in a 2012 study.
Mohamed Abdel-Fattah, a consultant urogynaecologist at Aberdeen Maternity Hospital, voluntarily published a correction to the paper on 18 January,2 more than six years after the paper was published. This came after a complaint was made to the General Medical Council about the failure to declare the £100 000 research grant from Coloplast.
The correction statement said, “A review of the funding in relation to this study revealed a further item that was inadvertently omitted from the original disclosure. This study was funded by the Henry Smith Charity. The University of Aberdeen also received a research grant from Coloplast. Coloplast had no input to any aspect of the study at any time from design to publication.”
Abdel-Fattah was the lead author of the study in question, a randomised controlled trial that reported a 73% success rate—as reported by patients at three years’ follow-up—for transobturator tension free vaginal tape for urodynamic stress incontinence. The trial found a significant drop in patient reported success rates between the first and third years of follow-up (P=0.005), but no independent risk factors were identified.
The safety of mesh implants has been brought into question in recent years, with hundreds of women taking legal action against the NHS and manufacturers after they experienced complications from surgery, including chronic debilitating pain, mobility problems, and loss of sex life.
Wael Agur, a consultant urogynaecologist and expert in mesh who made the complaint to the GMC in 2018, said that the funding should have been declared when the paper was submitted in 2012.
Agur told The BMJ, “In 2012 this was the most commonly used procedure in Scotland for incontinence. The study was influential in the sense that it gave reassurance about the use of mesh. [Surgeons] trusted the results and were reassured it was safe.”
Abdel-Fattah said that the grant was managed by the University of Aberdeen and that he had declared it in other papers. The omission from the 2012 paper was “regrettable” and “not an attempt to conceal the source of the funding,” he said, and he declared it as soon as it was brought to his attention.
With reference to the study’s influence on clinical practice, Abdel-Fattah added, “Data from this study also showed ‘significant deterioration of patient reported success rates’ and a ‘1:5 participant reporting deterioration in sexual life.’ In fact, data from this study were used by a mesh group to support their call for banning mesh in Scotland. The same study was also referenced in the FDA reclassification of mesh devices to higher risk devices.”
A statement from Aberdeen University said, “Professor Abdel-Fattah has been informed by the GMC that they looked into a complaint made against him, but the investigation has now been closed as of December 2018 with no subsequent action taken. Neither Professor Abdel-Fattah nor the University are aware of any further ongoing investigation.”
Abdel-Fattah made the amendment voluntarily, not in response to a request from the GMC, the university said.
Agur said he was told by the GMC that it was not acting on his complaint as its fitness to practise rules stipulate that it will not take forward allegations if “more than five years have elapsed since the most recent events giving rise to the allegation,” unless it considered that action was in the public interest.
Agur said that he has subsequently submitted fresh evidence to the GMC that he claims shows a failure to declare the same funding in relation to a paper published in 2017, but the GMC has not yet said whether it will take any action.
In response, Abdel-Fattah said, “Once [the matter of the 2012 paper] was brought to my attention, I took full responsibility and published a corrigendum and contacted editors of other relevant papers.”
In October 2018 the National Institute for Health and Care Excellence updated its recommendations on the use of surgical mesh or tape, to say that it should be used only to treat stress urinary incontinence or pelvic organ prolapse after all non-surgical options have been reviewed.
https://www.bmj.com/content/364/bmj.l462
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