Doctors Weigh in on TVT-SECUR during Ebaugh Pelvic Mesh Trial in Philadelphia
Mesh Medical Device News Desk, September 1, 2017 ~ The product liability trial of Ella Ebaugh – Case no 130700866 — is currently underway in the Philadelphia Court of Common Pleas before Judge Michael E. Erdos.
The following story reveals some of the insider information from the courtroom. This is the sixth trial in this venue putting Ethicon, a division of Johnson & Johnson on the hot seat.
Ella Ebaugh is 51 years old and a resident of Pennsylvania. She has had two Ethicon mesh implants – the TVT-Secur and the TVT (tension-free vaginal tape).
At age 39, Ms. Ebaugh had a TVT- Secur sling made by Ethicon (J&J) implanted on May 31, 2007 at Apple Hill Surgical Center in York,PA by Paul Douglass, MD. He reasoned since she was so young and had a very active lifestyle, the TVT-SECUR would allow her to get back to playing sports, particularly competitive softball, with her children.
Ms. Ebaugh had to have corrective surgery because of a mid-urethral sling erosion on July 12th that same year. At that time, she was implanted with another mesh, a TVT.
On June 14, 2011, she had a corrective surgery, due to mesh complications, with Dr. Howard Mirsky at York Hospital in Pennsylvania. March 14, 2102, she had her fourth surgery, and third corrective procedure at the University of Maryland Medical Center with Surgeon Dr. Toby Chai.
Dr. Chai did an ultrascope and thought mesh was in her bladder now. He didn’t find any but removed a few strands of mesh from the urethra. Finally, in 2016, Dr. Wright did a surgery to remove more mesh because she was still having complications.
“It’s one erosion, not three separate erosions,” explained Mr. Webb, an attorney for Ethicon, downplaying her complications in addressing the 12-member jury, all African-American, half men, half women and all middle aged.
Ebaugh is represented by Kila Baldwin of Kline and Specter. Her trail began July 31 in the Philadelphia Court of Common Pleas where there have been four victories and one partial victory for mesh-injured women totaling $48 million.
The action alleges design defect , negligence by J&J/Ethicon and strict product liability. It does not include a failure to warn* as the case did not proceed with that allegation (*This is a correction from earlier). J&J has never had to conduct any randomized controlled clinical testing. In mid-2012, the healthcare giant removed TVT-SECUR from the market along with three other problematic pelvic meshes including Prolift and Prolift +M and Prosima.
See MND story here.
It was a quiet, voluntary recall. The Food and Drug Administration, in a major concession to industry, then relieved the company of having to conduct post-approval monitoring studies.
Ebaugh Trial Doctors Testify About TVT-SECUR
The plaintiff’s first witness via videotape was Aran Maree, medical director of the Ethicon, Australia, Vice President of Medical Affairs and Chief Medical Officer starting in June 2006.
He was deposed July 22, 2013. Dr. Maree was interviewed by attorney Burn Snell representing Ethicon for the Engleman case. Portions of his deposition were played in the Ebaugh court.
Dr. Maree was responsible for a small clinical research team managing the quality assurance and quality systems teams. It was Dr. Maree who heard of the early failure reports of the TVT-SECUR. Anecdotal evidence indicates implanting the mesh required a specific technique for “potential optimal efficacy.”
There were three investigator-initiated randomized controlled trials, one in the Netherlands and two in the US in addition to the TVT World registry. There were more than 400 patients who had incontinence cured at 87% or higher with the TVT Secur.
At one point, Dr. Maree blocked the shipments of any TVT-SECUR pelvic meshes out of the Australian warehouse for use in Australia and New Zealand. The reason- the efficacy rate with TVT -SECUR was “unexpected” when compared to the efficacy rate of the TVT-O.
Dr. Maree asked for a quality block.
“Should we cease to market this product in Australia until we have objective evidence which gives us grounds for confidence that its use will ultimately see, be seen as having done the right thing for patients in Australia?”
Dr. Maree wrote, according to Ethicon documents, that Dr. Vincent Lucente had a 40% failure rate with the TVT-SECUR with his first 25 patients, and another had a 30% failure rate up to and including his first 77 patients.
Dr. Lucente is a name that has surfaced regularly in these pelvic mesh product liability trials. Paid About $2 million by the company, he was the company preceptor or trainer of a number of physicians training them on how to use Ethicon pelvic meshes.
Ethicon documents say, “In this light, and given that he was involved in training Dr. (blank) in Australia, it is not at all surprising that we may have similar, or higher, failure rates here.”
“I did find it noteworthy that Dr. Lucente appears to still be learning.”
One doctor reported he had “taken on board Dr. Lucente’s ‘modified technique’ but has not experienced a substantial improvement in success rates.” The concern was the original (and current) training program “may not result in competency in device insertion or result in clinical efficacy. There appear to be ‘tricks’ to insertion of the product and removal of the inserters which prevent dislodging the device in the process.”
TVT-SECUR was a sling unto itself and required a specific technique to implant. Some of the bad outcome might be operator error.
Three Australian surgeons reported failures with TVT-SECUR to Dr. Maree. Dr. Maree reported his concerns about “high failure rates” across multiple centers to Ethicon when the TVT-SECUR was compared to the TVT-O.
What resulted was a “tips and tricks” documents to be delivered to surgeons to revise technical points and fine tune the technique for implanting TVT-S. The Australian experience was not similar to the US.
Ultimately, Dr Maree sent a letter to surgeons in Australia warning of the unsuccessful procedures resulting for some doctors, sort of a safety alert, but not an official one.
Ms. Ebaugh suffers from pain, financial and economic loss, and permanent injury. She has accrued debt for medical services and expenses. She suffers recurrent UTI’s, pain with sex, pelvic abdominal and flank pain, bleeding, SUI urgency, anxiety and depression.
To deflect blame on Ethicon pelvic meshes, defense has said during this trial that she had these things before her implant and that Ms. Ebaugh said that a hip prosthesis she underwent in three months after her TVT-SECUR implant in 2007, “ruined her life.”
According to defense attorney W. Curtis Webb, during 2007 to 2011, “She’s not complaining about our product at all or that it was not working at all.”
Ebaugh v. Ethicon is set to conclude after the court resumes on Tuesday, September 5. ##