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Ethicon Media Monitoring 10/31/2018
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Other Countries Address Mesh Problems While the U.S. Stays Silent
Oct 30, 2018 | Periscope News Group
By Christina Morales
Within one month, both the Australian and Scottish governments have offered their apologies to women who have been terribly harmed by transvaginal mesh (TVM). -
Biorabsorbable polymer mesh gets FDA seal of approval
Oct 30, 2018 | Medical Plastics News
Surgical Innovation Associates (SIA), a start-up medical device company, has received 510(k) clearance from the US Food and Drug Administration (FDA) for DuraSorb Monofilament Mesh.
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Other Countries Address Mesh Problems While the U.S. Stays Silent
Oct 30, 2018 | Periscope News Group
By Christina Morales
Within one month, both the Australian and Scottish governments have offered their apologies to women who have been terribly harmed by transvaginal mesh (TVM). They acknowledged that they have “sympathy” for these women who are now facing immense pain and that “your voice has been heard, and not just heard but acted upon.”
And what does the U.S. government have to say to the hundreds of thousands of American women who have this dangerous medical device? NOTHING. It has either been halted or banned throughout the world, but it is still legal and commonly used in the U.S.What Should the U.S. Government Do to Protect Women from Mesh?
The UK, Scotland, and Australia have all make great strides in eliminating the use of vaginal mesh and the U.S. could easily follow their lead.Australia’s Health Minister Greg Hunt not only voiced his apology but stated that Australia’s government would work with states and territories to set up a voluntary national register. This would be a tool for women where they could report any health complications that resulted from their mesh implant. Additionally, the government has offered to pay for the removal and treatment of pelvic mesh and strongly encouraged states and territories to create an audit of pelvic mesh.Scotland’s First Minister Nicola Sturgeon announced that Scotland is enacting, “a temporary halt for all mesh procedures, and that will be lifted only when a new restricted use protocol is put in place… That will ensure that procedures are only carried out in future in the most exceptional of circumstances and subject to a very robust process of approval and fully informed consent.”Another flaw in America’s treatment of mesh is that instead of refining our FDA approval process, the FDA is attempting to shorten the 510(K) process to get more medical devices to market sooner. Vaginal mesh was originally approved for market because it was a device similar to what was used to help hernia patients. However, the tissue in the vagina is much thinner which allows the mesh to puncture the tissue and migrate. The vagina also has bacteria that pose a greater risk for infection than the abdomen.
During this election season, it’s time for political officials to listen to the millions of American women who want to protect our bodies from harmful medication devices and who want to amplify the voices of women who have been injured. If Scotland, the UK, and Australia can make a change for what’s right, then surely we can, too.
https://www.periscopegroup.com/transvaginal-mesh/time-for-us-to-ban-tvm
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Biorabsorbable polymer mesh gets FDA seal of approval
Oct 30, 2018 | Medical Plastics News
Surgical Innovation Associates (SIA), a start-up medical device company, has received 510(k) clearance from the US Food and Drug Administration (FDA) for DuraSorb Monofilament Mesh. It is said to be the first in a line of advanced bioabsorbable technologies for reconstructive and cosmetic surgery.
Each year, more than 1 million Americans are implanted with surgical mesh to provide the soft tissue support that is necessary in a variety of general and plastic surgical procedures. Much like an absorbable stitch, DuraSorb Monofilament Mesh is designed to integrate into the patient’s tissue – providing strong support during the critical initial phases of healing – and then slowly dissolve, leaving the patient free from foreign material within one year. The device brings polymer science and evidence-based engineering to bear on a material that has been used in other surgical applications for decades. DuraSorb will be released in select geographies in early 2019.
“The idea of a mesh that is there when you need it and gone when you don’t , is appealing, for much the same reason that absorbable sutures have become a key part of a surgeon’s armamentarium – tissue support from a foreign material is crucial during healing, but at some point thereafter may become a liability,” said Dr John Kim, inventor of the device and professor of Plastic Surgery at Northwestern University. “This technology was developed in direct response to unmet clinical needs in our field.”
Complications following mesh placements can range from long-term pain to non-healing wounds. Historically there has been a dichotomy between permanent synthetic meshes and biologic meshes. Permanent synthetics provide favorable long-term support in hernia surgery and abdominal wall reconstruction. However, they are known to expose patients to long-term risk of pain, non-healing wounds and complications during later operations. Biologic meshes – derived from human or animal cadavers – promise long-term biocompatibility once they integrate into the patient’s tissue, but carry excessively high cost, risk of adverse inflammatory reactions and mixed clinical results.
“Having known people who have gone through the pain of multiple mesh-related operations, I found it gratifying to collaborate closely with opinion-leading surgeons to make DuraSorb a reality,” said Alexei Mlodinow, CEO of SIA. “Their guidance went into every key decision during product development, and will now steer our clinical trial strategy as we replicate our robust preclinical data in a real-world setting.”
https://www.medicalplasticsnews.com/mpn-north-america/biorabsorbable-polymer-mesh-gets-fda-seal-of-approval/
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