Implant launched without clinical trial
Vaginal mesh device was marketed for years despite high failure rate
A vaginal mesh implant made by Johnson & Johnson was launched without a clinical trial, and marketed for five years after the company learned it had a higher failure rate than its two earlier devices.
Internal company emails disclosed in a US court case, in which a woman was awarded a record $57m in damages last week, also show senior executives even briefly considered suppressing unfavourable data that “could compromise the future” of the device.
J&J’s Ethicon unit was found by the court to be liable for injuries suffered by Ella Ebaugh, 51, after she was given a mesh implant. Ebaugh 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. In addition, a male executive bantered about a suggestion that sex with an earlier patient with mesh complications was “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”. In the event, the findings were presented at a major international conference.
The J&J tension-free vaginal tape (TVT) implant was launched in 2006. Despite the early signs it had a higher failure rate, it was only withdrawn in 2012 after being used in thousands of operations in the US, the UK and Australia. The documents raise questions for the manufacturers of vaginal mesh products, which are the subject of growing controversy.
The implants, which reinforce tissue around the urethra, are widely used to treat incontinence and for most women the procedure is quick and successful. However, some have suffered debilitating complications, including severe pelvic pain, and the mesh eroding through the vaginal wall or perforating organs. Class action lawsuits are under way in Australia and the US. In England, NHS data suggests as many as one in 15 women require full or partial removal of the implant.
Ebaugh, whose case was heard in Philadelphia, said her complications had left her with constant pelvic pain. “I feel like I’m on fire down there,” she told CBS.
The documents, revealed in the trial, highlight tensions between Ethicon’s commercial and clinical divisions at the time it launched its “miniature” mesh product, the TVT-Secur, in 2006. It hoped the device, which was smaller and required fewer incisions, would reduce complications seen with its earlier devices. But getting to market before competitors, who had similar offerings in the pipeline, was described as “priceless” in company papers. It was approved for use without a trial under US and European equivalence rules, which allow this when a new device is similar to existing ones.
Carl Heneghan, professor of evidence-based medicine at the University of Oxford, has called for a public inquiry into the use of mesh and criticised the decision to launch a device before a trial, saying this “led to direct patient harms”. “It has made it impossible to provide informed choice to women, and points to a regulatory system that is failing patients,” he said.
Prof Bernard Jacquetin, an eminent French gynaecologist whose early study on TVT-Secur had led to misgivings among J&J management, said the company had acted “irresponsibly” by launching the device without adequate evidence.
His team’s study of 40 patients found success rates of 77% two months after surgery, compared with roughly a 85%90% success rate commonly reported for Ethicon’s original TVT device. In 2012, TVT-Secur was withdrawn from the market, along with three other mesh products. J&J declined to provide exact figures on how many women had received the implants.
The company said it planned to appeal against the verdict.