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Ethicon 2/17
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For vaginal repair, benefits of mesh must be weighed against harms
Feb 16, 2016 | Reuters
By Andrew M. Seaman
Synthetic mesh is more effective for correcting vaginal prolapse than using a woman's own tissue, but the overall benefit is small, according to a fresh look at some past research. -
The FDA Warnings Over The Use Of Transvaginal Mesh
Feb 16, 2016 | FDA News Alert
By Ruchi Gupta
The issuance of safety communications by the US Food and Drug Administration (FDA) for the use of transvaginal mesh seems to bring along different influences. -
Strengthening Surgical Mesh Safety
Feb 16, 2016 | The Journal of the American Medical Association
By Rebecca Voelker
Two final orders from the FDA have targeted serious complications linked with surgical mesh used for transvaginal repair of pelvic organ prolapse. -
Judge’s Order to Boston Sci – DO NOT Destroy Chinese Pelvic Mesh or Docs!
Feb 16, 2016 | Mesh Medical Device News Desk
By Jane Akre
Harris Co. District Court Judge Jaclanel McFarland ordered the company not to dispose of or alter any supplies of polypropylene (PP) resin sitting in an Indiana warehouse that allegedly was smuggled in from China without any regulatory oversight.
Client Attorney Privileged/Attorney Work Product/At Request of Counsel
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For vaginal repair, benefits of mesh must be weighed against harms
Feb 16, 2016 | Reuters
By Andrew M. Seaman
Synthetic mesh is more effective for correcting vaginal prolapse than using a woman's own tissue, but the overall benefit is small, according to a fresh look at some past research.
In vaginal prolapse, the vagina may fall out of its normal position because of weakened muscles and ligaments. Often, nearby structures such as the uterus, rectum, and bladder fall down into the vagina as well.
Researchers have found that up to three years after surgery, women whose prolapse was repaired with artificial mesh were less likely to be aware of recurrent prolapse than those whose repair was done with natural tissue. But they were also more likely to have incontinence, exposed mesh or another surgery.
About one in 20 women whose prolapse was fixed with natural tissue had a second operation, compared to about one in 10 women who got artificial mesh, said lead author Dr. Christopher Maher, of the Royal Brisbane Women's Hospital in Australia.
Prolapse is seen in 40 to 60 percent of mothers, the researchers report in the Cochrane Library. Out of every 10,000 women in the U.S., about 10 to 30 undergo surgery to repair prolapses each year, they add.
Repairs using mesh became popular in the late 1990s and early 2000s after it was successfully used in other types of operations, wrote Dr. Cindy Farquhar, of the University of Auckland in New Zealand, in an accompanying editorial.
But at first, mesh repair of prolapse was adopted without rigorous studies to test the practice, and a rise in complications tied to the use of mesh led the U.S. Food and Drug Administration (FDA) to issue warnings and take other regulatory actions, Farquhar added.
The new review from the Cochrane Collaboration, which evaluates the best medical evidence for various treatments, looked at 37 randomized controlled trials that tested mesh repairs in a total of 4,023 women.
In general, recurrent prolapse was 60 percent less likely after mesh repair. In other words, the researchers say, if 38 percent of women have recurrence after repair with natural tissue, only 11 to 20 percent would have recurrence after repair with mesh.
But those who had repairs with mesh were more likely to have incontinence, exposed mesh and other issues, like bladder injuries, and they were more likely to need another operation.
Women could consider these types of mesh surgeries if they fully understand the risk and benefits, Maher told Reuters Health.
He also said doctors "should await comparative data on new innovations to ensure they have been fully evaluated prior to introduction to treatment pathways." And "women should be cautious" when new innovations are recommended to them.
Dr. John Gebhart, who was not involved with the new review, said that in the next couple of years, more data about results with mesh for vaginal prolapse will likely be available, when studies ordered by the FDA are completed.
"I think the ultimate takeaway is that patients should continue to ask questions of their physicians and ask what the pros and cons of each approach are for the patient," said Gebhart, a urogynecologist at the Mayo Clinic in Rochester, Minnesota.
SOURCE: bit.ly/1PPoLWW and bit.ly/1Qjzkar Cochrane Library, online February 16, 2016.
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The FDA Warnings Over The Use Of Transvaginal Mesh
Feb 16, 2016 | FDA News Alert
By Ruchi Gupta
The issuance of safety communications by the US Food and Drug Administration (FDA) for the use of transvaginal mesh seems to bring along different influences. A recent study has revealed that the safety communication given in 2008 and 2011 presented different results.
The 2008 warning led to an increased use of the surgical mesh from 21% to 30% in 2011. Nevertheless, after the second warning which was more severe, the usage declined to 23% in 2013 from 30% in 2011. The big question is what led to the difference in usage patterns of this surgical mesh that treats pelvic organ prolapse (POP)?
Well, according to the researchers, the usage patterns difference may have resulted from the FDA’s 2011 warning that was considered stronger. Having come across 3,000 incidences of the transvaginal mesh, between 2008 and 2010, the FDA was very categorical in its warning while a host complications the likes of pain when urinating, urinary tract infections, vaginal scarring, infection and bleeding among others.
The researchers also argued the decrease of usage may have been caused by the fact that non-teaching and low- and medium- volume hospitals more often than not experience less severe cases of POP. Remarkably, the meshes are in common use by thousands of women to strengthen the damaged vaginal walls to support the pelvic organs.
Apparently, the surgical mesh had received approval in 2002 through the 510(k) pathway. The approval was based on the significant correspondence to the surgical mesh used for abdominal hernia repair. However, the FDA had to issue a safety communication warning after it emerged that there was a rare complication associated with the mesh.
The FDA could not ascertain the real cause of the difficulty, but physicians were asked to undergo training for surgical placement procedures and also monitor patients carefully to avert adverse events.
But before the dust could settle down 3,000 cases of complications linked to the use of surgical mesh were reported again between 2008 and the end of 2010. It is at this point that the FDA issued a second but stronger warning. At the same time, manufacturers of the surgical mesh were ordered to conduct post-market studies and also submit a premarket approval (PMA) for the devices.
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Strengthening Surgical Mesh Safety
Feb 16, 2016 | The Journal of the American Medical Association
By Rebecca Voelker
Two final orders from the FDA have targeted serious complications linked with surgical mesh used for transvaginal repair of pelvic organ prolapse.
The agency reclassified the mesh as a high-risk device and will require manufacturers to submit a premarket approval application demonstrating the safety and effectiveness of their product (http://1.usa.gov/1MPbStj). The orders don’t apply to surgical mesh for other indications such as stress urinary incontinence or abdominal repair of pelvic organ prolapse...
For full story, go to:
http://jama.jamanetwork.com/article.aspx?articleid=2491624 -
Judge’s Order to Boston Sci – DO NOT Destroy Chinese Pelvic Mesh or Docs!
Feb 16, 2016 | Mesh Medical Device News Desk
By Jane Akre
Harris Co. District Court Judge Jaclanel McFarland ordered the company not to dispose of or alter any supplies of polypropylene (PP) resin sitting in an Indiana warehouse that allegedly was smuggled in from China without any regulatory oversight.
Boston Scientific (BSX) turned to an unknown Chinese supplier after its source of U.S. – made PP known as Marlex, refused to supply BSX with the raw resin. Supplier, Chevron Phillips, had learned the resin was to be used for mesh medical devices that would be permanently implanted in the human body, in violation of its own direction that specify the resin was NOT to be used for implantable medical devices.
Bard Marlex Mesh MSDS
Chevron and Phillips Sumika of LaPorte, Texas (which has since moved to Saudi Arabia) manufactured Marlex HGX-030-01, the specific polypropylene, which is the basis for FDA clearance of the BSX product. Any new formulation requires the company to reapply to the FDA for clearance to sell its medical device.
Mostyn Law of Houston filed a federal racketeering lawsuit last month accusing the company of conspiring with a Chinese supplier to import 34,000 pounds of a counterfeit Marlex which “contains high levels of toxic selenium,” says the law firm in a news release. “And if Boston Scientific won’t do the right thing, the FDA should make them do it without delay,” says Amber Mostyn.
Included in the order is the destruction of any of the following- shipping orders, customs forms, and communications with suppliers.
The federal lawsuit filed by Mostyn law is the first to invoke the Racketeering and Corrupt Organizations Act (RICO), which is traditionally used in organized criminal activity.
The case is styled Stevens v. Boston Scientific Corp., et. al., 2:16-0265, U.S. District Court, Southern District of West Virginia.
It echoes the order placed and violated by Johnson & Johnson which was found to have destroy hundreds of thousands of pages of documents pertaining to transvaginal mesh that were under a litigation hold. Besides a reprimand from the court, Magistrate Cheryl Eifert, there has been no sanctions against J&J. See background story from Mesh News Deskhere and here.
The firm hopes to turn the RICO action into a class action on behalf of those women implanted with the counterfeit made resin.With Boston Scientific using about 3,000 to 4,000 pounds of resin a year, Steve Mostyn believes that leaves thousands of pounds sitting in a warehouse.
“Who knows how it’s stored. They transported it in brown paper sacks. I don’t know if the warehouse is climate controlled, rodent or insect controlled. If the shelf life of Marlex is ten years there is no way to assume when it was made,” Steve Mostyn tells Mesh News Desk.
Mostyn is concerned hundreds of his clients may have been implanted with the mesh made from Chinese Marlex resin.
Last month, U.S. District Judge Joseph Goodwin, who is overseeing the multidistrict litigation concerning transvaginal mesh litigation, directed the plaintiff to take the counterfeit mesh controversy to the Food and Drug Administration (FDA) for the agency to determine whether the counterfeit mesh poses a problem for use in vaginal implants. See the story here.
Plastic toys made in Guangdong province
Internal company documents that show the extent of the conspiracy remain confidential and Judge Goodwin, who retained jurisdiction over the case, has the authority to release them to the public. Those documents were generated between 2011 and 2012, the years that the alleged smuggling of 34,000 pounds of material were brought into the U.S. without any oversight by EMAI Plastic Raw.
Mostyn tells Mesh News Desk they now believe that was fake company with an address to a storefront in Guangdong Province, China’s hub for manufacturing plastic toys. The province was called the world’s largest electronics waste dump, according to a 2015 Reuters story here.
LEARN MORE:
Mostyn Law Press Release Release
http://www.prnewswire.com/news-releases/mostyn-law-wins-court-order-barring-boston-scientific-from-destroying-evidence-300214064.html
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