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Broadly Covers Transvaginal POP Mesh Issue with MND Input
Jan 7, 2016 | Mesh Medical Device News Desk
By Jane Akre
Your editor, Jane Akre was interviewed for this January 5th story in “Broadly” a unit of the HBO show VICE. -
Pelvic Mesh Case Before Texas SC Could Impact Thousands of Others
Jan 7, 2016 | SE Texas Record
By David Yates
In November, a Dallas appellate court reversed a $1.2 million jury verdict rendered against Johnson & Johnson for allegedly designing a defective pelvic mesh product. -
FDA Takes Stronger Action on Surgical Mesh for POP
Jan 7, 2016 | Urology Times
By Lisette Hilton
The FDA has issued two final orders to strengthen the data requirements for surgical mesh to repair pelvic organ prolapse (POP) transvaginally.
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Broadly Covers Transvaginal POP Mesh Issue with MND Input
Jan 7, 2016 | Mesh Medical Device News Desk
By Jane Akre
Your editor, Jane Akre was interviewed for this January 5th story in “Broadly” a unit of the HBO show VICE.
Read the story here.
Reporter Gabby Bess was seeking a comment on the new Food and Drug Administration rule that reclassifies mesh used for pelvic organ prolapse or POP to high risk. Currently it enjoys a “moderate risk” classification as class II. For the next 30 months, mesh manufacturers must submit to the FDA proof that their mesh in safe and effective.
Any new pelvic mesh introduced for POP repair will have to provide clinical trials or proof of safety. Without proof which was previously not required, the mesh will have to be removed from the market.
Many mesh manufacturers have already removed their POP mesh from the market. See the background story here.
Must used for stress urinary incontinence or SUI is a smaller piece of mesh but it will remain in class II and will not require the more stringent requirements of class III.
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Pelvic Mesh Case Before Texas SC Could Impact Thousands of Others
Jan 7, 2016 | SE Texas Record
By David Yates
In November, a Dallas appellate court reversed a $1.2 million jury verdict rendered against Johnson & Johnson for allegedly designing a defective pelvic mesh product.
On Dec. 18 the plaintiff in the case filed a petition for review with the Texas Supreme Court, asserting her case presents a question that will impact thousands of others: what evidence is necessary to satisfy the causation standard in a products liability case involving an implanted medical device.
Plaintiff Linda Batiste, who has a “complex” medical history, filed suit against Johnson & Johnson and its subsidiary, Ethicon, in Dallas County, alleging she was injured by the defendants’ polypropylene mesh.
A jury found the medical product, the TVT-Obturator, was defectively designed, awarding Batiste $1.2 million in damages, court records show.
Johnson & Johnson appealed the judgment in July 2014, arguing the trial court erroneously: excluded all FDA evidence; excluded evidence from independent physician organizations that contradicted the plaintiff’s theories of injury; and admitted evidence of other lawsuits and unverified issue reports.
On Nov. 5 the Fifth Court of Appeals found that Batiste was required to prove a specific defect in the TVT-O, and not simply the device itself, which is known to sometimes cause a number of complications.
“Because Batiste failed to offer legally sufficient evidence that any alleged defect in the TVT-O was the producing cause of her injuries, we reverse the trial court’s judgment and render judgment that Batiste take nothing,” the Fifth Court opinion states.
“Although Batiste alleged the TVT-O was defective based on its use of mechanically cut, heavyweight, small-pore mesh that was subject to degradation and particle loss, she failed to produce more than a scintilla of evidence that any of these alleged defects caused her injuries.
“Accordingly, the evidence is legally insufficient to support the jury’s verdict.”
In her petition, Batiste is asking the high court to clarify whether the Dallas appeals court accurately interpreted Texas common law to hold a product liability plaintiff must isolate the cause of her injuries to a “specific defect” in a medical device case.
Court records show Batiste has a complex medical history. She has had nine abdominal surgeries, including two “C-sections,” two open abdominal procedures, and five laparoscopic procedures. In 2003, she had a stroke that left her disabled. She had a second stroke in 2007.
Due to spinal disease, she has undergone four surgeries in her lower back and one surgery in her neck. Following a heart attack, a stent was placed through her femoral artery to address a ninety-five percent blockage in her right coronary artery.
Batiste has also been diagnosed with chronic obstructive pulmonary disease, a result of smoking and suffers from poorly controlled diabetes.
The TVT-O was implanted to treat her stress urinary incontinence, court records show.
Batiste is represented in part by Tim Goss of Freese & Goss, a Dallas firm.
Johnson & Johnson is represented in part by Scott Stolley, attorney for the Dallas law firm Thompson & Knight.
Supreme Court case No. 15-0975 -
FDA Takes Stronger Action on Surgical Mesh for POP
Jan 7, 2016 | Urology Times
By Lisette Hilton
The FDA has issued two final orders to strengthen the data requirements for surgical mesh to repair pelvic organ prolapse (POP) transvaginally.
One leading expert predicted the orders would have significant future implications for the use of surgical mesh for POP.
The first order reclassifies these mesh medical devices from class II (which generally includes moderater-risk devices) to class III (which generally includes high-risk devices), and the other requires manufacturers to submit a premarket approval application to support a device’s safety and effectiveness for transvaginal POP repair.
The FDA said in a press release that the orders apply only to mesh devices marketed for the transvaginal repair of POP and do not affect the use of surgical mesh for other indications, including stress urinary incontinence and abdominal repair of POP.
“These stronger clinical requirements will help to address the significant risks associated with surgical mesh for repair of pelvic organ prolapse,” said William Maisel, MD, MPH, of the FDA’s Center for Devices and Radiological Health, in the FDA release.
“We intend to continue monitoring how women with this device are faring months and years after surgery through continued postmarket surveillance measures,” Dr. Maisel added.
Manufacturers of surgical mesh to treat POP transvaginally will have 30 months to submit a premarket approval for devices that are already on the market. Manufacturers of new devices must submit a premarket approval before those devices can be approved for marketing, according to the FDA.
Urologist J. Christian Winters, MD, of Louisiana State University Health Sciences Center, New Orleans, told Urology Times the FDA’s moves have profound future implications for the use of surgical mesh for transvaginal repair of POP, but the immediate impact on urologists and their patients might not generate swift change.
“In my mind, the impact has already largely happened. There has been a substantial decrease in the use of that treatment modality already, both patient-driven and to some degree physician-driven,” said Dr. Winters, immediate past president of the Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction. “It’s my understanding that products that are in existence have to undergo post-market studies and those studies are underway and ongoing. The studies have to compare the [surgical mesh] procedure to the safety and efficacy of other procedures. The final results of those studies will determine a lot—as to, in the future, whether this is going to be a modality that is going to be readily available or not.”
Manufacturers attempting to bring new surgical mesh products to market for transvaginal repair of POP will be required to go through the more rigorous data demands of a class III device approval, “which is going to require a lot more data and a larger wealth of pre-launch experience. So, that’s the big factor in the future for the manufacturers. It’s going to be harder to get these things to market,” Dr. Winters said.
For now, at least, surgical mesh for repair of POP is still part of the conversation between urologists and some of their patients, according to Dr. Winters.
“In a woman who has had multiple abdominal surgeries, who is relatively young, and has failed a vaginal prolapse repair already, I think the option of surgical mesh is a part of the informed discussion regarding treatment options that has to be had with that patient,” he said. “I think doing [the surgical mesh procedure] in a routine prolapse case, a more straightforward case—or in the posterior compartment—that’s largely fallen out of favor.”
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