When it emerged from initial data that the success rates for a new device looked to be way below those seen for previous products, Ethicons director of sales, Xavier Buchon, suggested in an email stop[ping] for a while such publications that could compromise the future.
The J&J implant, used to treat urinary incontinence, was launched in 2006. Despite the early indications of a high failure rate, it was only withdrawn in 2012 after being used in thousands of operations in the US, the UK and Australia.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 uncomfortable 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 the majority of women the procedure is quick and successful. However, some women have suffered debilitating complications, including severe pelvic pain, the mesh eroding through the vaginal wall or perforating organs.
Class action law suits are underway in Australia and the US, where lawyers claim that patients have been exposed to unacceptable risks; in England, NHS data suggests as many as one in fifteen women later requires full or partial removal of the implant.
Vaginal mesh implant
Ebaugh, whose case was heard in Philadelphia, said that her complications have left her with constant pelvic pain, meaning for example, that although she attended her daughters recent wedding, she was unable to enjoy it. I feel like Im on fire down there, she said in an interview with CBS.
The tranche of documents, revealed during the trial, places a spotlight on tensions between Ethicons commercial and clinical divisions at the time it launched its miniature mesh product, called the TVT-Secur, in 2006.
The company hoped that the new device, which was smaller and required fewer incisions, would reduce complications seen with its earlier devices. But getting to market ahead competitors, who had similar offerings in the pipeline, was described as priceless in company documents. 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 who has called for a public inquiry into the use of mesh, condemned the decision to launch a device before a trial, saying this had 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 added.
Prof Bernard Jacquetin, an eminent French gynaecologist whose early study on TVT-Secur had led to misgivings among J&J management, told the Guardian the company had acted irresponsibly by launching the device without adaquate evidence.
Ahead of the devices original launch, Jacquetin was invited to the US to give advice on the new design, but was taken aback when he was presented with a boxed-up product ready for release. Jacquetin and colleagues later carried out a study in 40 patients, which found success rates of 77% two months after surgery, compared to the roughly 85-90% success rate commonly reported for Ethicons original TVT mesh device.
On learning that Jacquetins results did not look promising (though not referring to the eventual 77% figure), marketing manager, Fabrice Degeneve emailed his superiors to ask: How should we handle this without compromising the use of this new technique?
Ethicons director of sales, Xavier Buchon, replied: This is for sure a big concern, before suggesting withholding results while the company reviewed the patients to be included in the analysis. No way to hide the truth but to make sure it has been done correctly in terms of procedure and inclusion, he added.
In the event, the findings were presented at a major international conference and Jacquetin said he never felt pressure to bury unfavourable results. But he adds: I was really disappointed. I told many people at Ethicon it was not [a good 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.
In other emails, J&J staff complain of colleagues constantly spinning data and of a dangerous blurring of the lines between commercial and research divisions. I am continually amazed and surprised at our need to push back, wrote Judi Gauld, Ethicons former clinical director in Scotland.
Other emails show a blas attitude to distressing complications. In one, dated from 2003, a surgeon sought advice on treating a patient with a 2cm stretch of mesh poking through her vaginal wall. Sex is like screwing a wire brush according to her spouse, the doctor wrote. Martin Weisberg, Ethicons medical director, replied: Ive never tried the wire brush thing so I wont comment.
Following the trial, Ebaughs lawyer, Kila Baldwin, said in a statement: I am pleased the jury recognised the recklessness of J&J and I hope the company takes notice of the verdict and adjusts its practices accordingly.
Johnson & Johnson said they plan to appeal the verdict. In a statement, the company said: We believe the evidence in the Ebaugh trial showed Ethicons TVT and TVT-Secur devices were properly designed, Ethicon acted appropriately and responsibly in the research, development and marketing of the products, and the products were not the cause of the plaintiffs continuing medical problems.
Over two and a half million documents have been provided to plaintiff attorneys by Ethicon as part of the pelvic mesh litigation in the United States, and selective disclosure of certain sentences or documents without proper context can be extremely misleading.