Revealed: Johnson & Johnson's 'irresponsible' actions over vaginal mesh implant
A vaginal mesh implant made by Johnson & Johnson (J&J) was launched without a clinical trial, and then marketed for five years after the company learned that it had a higher failure rate than their two earlier devices.
Internal company emails disclosed in a US court case, in which a 51-year-old woman was awarded a record $57m in damages this month, also show that senior executives even briefly considered suppressing unfavourable data that “could compromise the future” of the device.
J&J’s Ethicon unit was found by a US court to be liable for the serious injuries Ella Ebaugh suffered after receiving a mesh implant to treat urinary incontinence. The mother of five said she was left with a mangled urethra, bladder spasms and continual pelvic pain after an unsuccessful procedure that led to three revision surgeries to remove mesh that had cut into her urethra and migrated to her bladder.
But documents submitted to the court show J&J staff had raised concerns about the “spinning of data” in emails and male executives are seen bantering about a suggestion that sex with an earlier patient with mesh complications must be “like screwing a wire brush”.
When it emerged from initial data that the success rates for a new device looked to be “way below” those seen for previous products, Ethicon’s director of sales, Xavier Buchon, suggested in an email “stop[ping] for a while such publications that could compromise the future”.
https://www.theguardian.com/society/2017/sep/29/revealed-johnson-johnsons-irresponsible-actions-over-vaginal-mesh-implant
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