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Ethicon 29/6
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Caldera Medical wins FDA 510(k) for next-gen Vertessa Lite mesh
Jun 26, 2015 | Mass Device
By Fink Densford
Caldera Medical said today it won FDA 510(k) clearance for its next-generation Vertessa Lite polypropylene mesh for treating pelvic organ prolapse. -
FDA gives nod to newest pelvic mesh product, despite ongoing safety issues
Jun 26, 2015 | Fierce Medical Devices
By Stacy Lawrence
Despite this caution, startup Caldera Medical has received an FDA clearance for its latest iteration of Vertessa Lite mesh, which has been cleared for use in surgery to address pelvic organ prolapse. -
*New* J&J Execs Have Some Explaining To Do About Pelvic Mesh Particles
Jun 26, 2015 | Mesh Medical Device Newsdesk
By Jane Akre
Darlene Kyle from Ethicon told the J&J rep from Medical Taiwan, the corporate communications department of J&J in Taiwan. “No this is not normal nor do we recommend using the product.”
Client Attorney Privileged/Attorney Work Product/At Request of Counsel
Online Sources
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Caldera Medical wins FDA 510(k) for next-gen Vertessa Lite mesh
Jun 26, 2015 | Mass Device
By Fink Densford
Caldera Medical said today it won FDA 510(k) clearance for its next-generation Vertessa Lite polypropylene mesh for treating pelvic organ prolapse.
The new version of the mesh is lighter, 31% stronger than other market-leading meshes and has a 32% increased suture pull out strength, the Agoura Hills, Calif.-based company said.
“As part of our continuous product development efforts we are excited to announce the launch of a new generation of Vertessa Lite. Our mission is to improve the quality of life for women and every day we work towards that goal. I am proud to say that we took another step forward with our new Vertessa Lite mesh for sacrocolpopexy, which will improve the quality of life for women suffering from pelvic organ prolapse,” CEO Bryon Merade said in a press release.
Forty percent of women have some form of prolapse, and it is estimated that up to 250,000 surgical procedures are performed each year to treat the issue, Caldera Medical said.
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FDA gives nod to newest pelvic mesh product, despite ongoing safety issues
Jun 26, 2015 | Fierce Medical Devices
By Stacy Lawrence
The U.S. Food and Drug Administration has signed off on the latest iteration of a pelvic mesh, despite the ongoing controversy around this type of device and a huge settlement from Medtronic ($MDT) for more than 11,000 vaginal mesh patients earlier this week.
The agency has said since 2011 that serious complications for transvaginal repair of pelvic organ prolapse are not rare--and that it's not clear that the use of mesh in that repair is more effective than a surgical repair that does not include the use of mesh. In addition, the FDA is in the midst ofconsidering a reclassification of pelvic mesh from a moderate risk, or class II device, to a high-risk device, which is class III and requires a premarket approval (PMA) application.
"The FDA has identified clear risks associated with surgical mesh for the transvaginal repair of pelvic organ prolapse and is now proposing to address those risks for more safe and effective products," Dr. William Maisel, deputy director of science and chief scientist at the FDA's Center for Devices and Radiological Health, said in April 2014 when the agency disclosed that it was considering the reclassification.
"If these proposals are finalized, we will require manufacturers to provide premarket clinical data to demonstrate a reasonable assurance of safety and effectiveness for surgical mesh used to treat transvaginal POP repair," he added.
Despite this caution, startup Caldera Medical has received an FDA clearance for its latest iteration of Vertessa Lite mesh, which has been cleared for use in surgery to address pelvic organ prolapse. The company is among the many that has beennamed in the more than 70,000 lawsuits regarding vaginal mesh.
The company said the newest version of the mesh is lighter, stronger and has larger pores. The larger pores, about 1,500 microns, as well as the light weight is intended to improve acceptance of the mesh by host tissue. The mesh, made of monofilament polypropylene, comes in a trio of configurations: Y-shaped, flat sheets and strips. But Caldera doesn't cite any specific safety advantages for Vertessa Lite, which the agency first signed off on in 2013. FierceMedicalDevicesreached out to Caldera for comment, but hadn't received a response at press time.
According to the FDA, the most common pelvic mesh complications include erosion through vaginal epithelium, infection, pain, urinary problems, and recurrence of prolapse and/or incontinence. There are also reports of bowel, bladder, and blood vessel perforation during insertion.
Caldera noted that an estimated 40% of women have some form of pelvic prolapse, with as many as 250,000 surgeries to treat it annually. The company claims that "abdominal sacrocolpopexy with mesh placement is considered to be one of the most effective surgical procedures with one of the highest long-term success rates for vaginal vault prolapse."
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*New* J&J Execs Have Some Explaining To Do About Pelvic Mesh Particles
Jun 26, 2015 | Mesh Medical Device Newsdesk
By Jane Akre
According to court documents filed this week, Johnson & Johnson and its Ethicon division must have corporate designees ready to be deposed August 5 in Morristown, New Jersey.
The subject – why its TVT (transvaginal tape), including the TVT-O mesh (transobturator tape) has had a problem with mesh particles and possible foreign matter found in the packaging material and why the company issued assurances of safety to doctors if the degrading products are used in patients.
The complaints began to come in from a hospital in Taiwan in July 2010. Doctors found boxes with tiny blue particles in the mesh product packaging and sent it back to the company’s New Jersey headquarters. In all, ten boxes of TVT-O were returned to the company.
Darlene Kyle from Ethicon told the J&J rep from Medical Taiwan, the corporate communications department of J&J in Taiwan. “No this is not normal nor do we recommend using the product.”
But later she asked Ethicon’s headquarters for a “formal letter saying it’s safe” that would be shown to implanting physicians.
Meng Chen of Ethicon, who was in charge of customer complaints, writes in an October 5, 2010 email, “After careful review of the available information in the files and the information provided from the manufacturing site, the Business Unit Medical Director and I feel that the possibility for the tiny tape fragments observed in these five cases to cause adverse consequence in a patient, a device administrator or others should be considered remote. The presence of tiny tape fragments in the product package is not expected to change the product safety profile.”
What was the scientific basis for that conclusion plaintiffs’ attorneys will want to know.
The deposition request was filed by Tom Cartmell of Wagstaff and Cartmell of Kansas City, Missouri. The Notice to Take Oral Depositions was filed June 25 in the multidistrict litigation before Judge Joseph Goodwin in Charleston, West Virginia. The Ethicon MDL is 2:12-md-02327. This was Document #1609, #1609-1, #1609-2.
What Did the Company Know, What Did They Do
Attorneys will ask the corporate representatives how many complaints they received of particles or foreign material in TVT packaging or products; for any correspondence regarding whether the meshes were safe to use; communications regarding the cost of any potential recall of any TVT lot; the actual letter supplied to doctors that the product is safe to use; the scientific analysis of patient consequences of particles or foreign matter that might inadvertently be implanted or break off in the human body; communications regarding the returned products and any testing or analysis conducted on the products; documents concerning the cleaning of equipment used for cutting, packaging or sterilizing said mesh products and any inspections that should have occurred, among other questions.
There is no word yet on who Ethicon will send though Meng Chen has appeared on behalf of Ethicon at trial.
Ethicon makes pelvic meshes as a division of Johnson & Johnson. At this writing the company is facing 26,851 product liability lawsuits (here) consolidated in this one federal court as well as cases filed in state courts around the country. Women complain the permanent implants have left them in pain, with chronic infection and many are unable to walk or to work. The mesh was originally used to address incontinence and many complain it was ineffective in that regard.
J&J has more defective product cases than another of the seven manufacturers, yet it has offered no mass settlements to date, just individual settlements during or before trial.
Particles in Blisters
Attached to this filing is an Ethicon publication “Particles in TVTO Blisters” which refers to packaging, issued by the company office in Switzerland. It says “Since July 2010, 6 complaints have been recorded for the following issue: Foreign Matter in TVTO blisters.” It lists the foreign matter found in J&J (Ethicon) packing of TVT products sold to Taiwan and South Africa.
Women affected by pelvic mesh have also noted the breakdown of particles in packaging of products purchased online, even among meshes that are within their shelf life.
Mesh particles are thought to incite foreign body response to the polypropylene and may create biofilms that protect colonies of bacteria that continue to thrive even after mesh implant is removed.
Mesh is cut both by machine and by laser. The Swiss publications says “Particles belonging to the product in the blister (blue or white based on mesh being process) inferior to 0.4mm2 or 3mm is acceptable” while particles not belonging to the product are not acceptable. #
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