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US FDA halts the use of mesh for female incontinence/prolapse
Please see the article below. This is a huge development. This is the same type of polypropylene mesh that is used in hernia repair and have many similarities.
For years woman have been complaining of horrible pain symptoms after their surgeries that used mesh only to have their concerns fall in deaf ears by their implanting surgeons, mesh manufactures, and medical community.
Many women left in debilitating pain only to be brushed off by their impmaitng surgeons: very similar to those of us who had issues after mesh implantation with polypropylene mesh.
Very few surgeons (less than 5 in the US) with the expertises in agreeing that these meshes are the result of the pain and who are skilled enough to completely remove it from the sensitive area of the female: very similar to the mesh removal area now-only a handful of surgeon recognize mesh issues and are skilled enough to safely remove the mesh.
Similar to the “Female mesh “ many woman did well with the surgery but many did not and were not only left in pain and often debilitating pain but were abandoned by the medical community, while the mesh manufacturers took no responsibility.
This is the current state of the hernia mesh world-many seem to do well but others are harmed and damaged without zero accountability from anyone.Ober the years the lawsuits built up and although slow to act compared to other countries the US seems to finally have taken action.
This is the same type of polypropene mesh that has become the gold standard in hernia repair in which 99% of hernia repairs use this material in the US. Although I’m sure the medical community and mesh manufacturers will try to claim these are two totally different operations-the fact of the matter is both meshes are made out of the same material and only speaking from a males perspective inguinal hernia mesh is placed as close to the male organ and on top of or behind many of the male structures.
As fhe hernia mesh lawsuits are set to pile up in the upcoming years and as a man who was damaged by hernia mesh and had to go through the ordeal of mesh removal it seems it is only a matter of time for some much needed reform in the hernia surgery and mesh arena. Amen.
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6 Replies
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J&J settles in Washington state pelvic mesh lawsuit, on eve of trial start.
It will be interesting to see how disclosure changes for hernia repair mesh in Washington state after this recent settlement with J&J. Washington state sued them over what is, basically, false advertising. Not disclosing the risks. J&J did not admit fault, but still paid. The state said that they could not ban the devices because the FDA approved them. At least somebody is defining the various types of wrongness. The buck has to stop somewhere, it can’t travel in an endless circle of buck-passing.
https://www.knkx.org/post/johnson-johnson-settles-lawsuit-washington-state-over-pelvic-mesh-implants
“The health care giant Johnson & Johnson will pay nearly $10 million to Washington state to settle a lawsuit over the marketing of pelvic mesh implants.”
“Washington state’s lawsuit against Johnson & Johnson, filed in May 2016, was over misrepresentation of risks associated with the implants. Washington Attorney General Bob Ferguson said the company violated the state’s Consumer Protection Act by not adequately warning patients and doctors of the risks.
In announcing the settlement, Ferguson said going forward the company will be required to spell out those risks. “Our resolution is sending a clear message, that you cannot sell medical devices in Washington state and fail to adequately disclose the risks associated with those products,” Ferguson said.”
“As for banning the devices outright, Ferguson said that is beyond the reach of Washington’s Consumer Protection Act because pelvic mesh implants have been approved for use by the Food and Drug Administration.”
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I am temporarily living in New Zealand.
I tried posting links to pelvic mesh and hernia mesh articles on a New Zealand news website, but my post was unapproved.
If you go to http://www.stuff.co.nz and do searches for pelvic mesh and hernia mesh there are several links to news stories. -
I am temporarily living in Christchurch, NZ.
I looked for articles regarding pelvic mesh and found a recent article, dated April 18, 2019, on Stuff, a New Zealand news site.April 18, 2019 / US Food and Drug Administration halts pelvic organ mesh sales
https://www.stuff.co.nz/national/health/112106164/us-food-and-drug-administration-halts-pelvic-organ-mesh-sale [h=1]March 30, 2018 / Calls for NZ to follow Australian senate surgical mesh report, which says use it as ‘last resort’[/h] https://www.stuff.co.nz/national/health/102689722/calls-for-nz-to-follow-australian-senate-surgical-mesh-report-which-says-use-it-as-last-resort?rm=a
There are other articles about pelvic mesh.
Scroll down for news stories on the Stuff website.Here is a link to several articles about hernia mesh also on stuff.co.nz
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Hi. I believe New Zealand was the first country to ban female pelvic mesh and either Australia has or has out it on hold to investigate.
i should mention that it seems here in the US only one type of pelvic mesh has been halted and roger mesh for say urinary incontinence is still allowed as well as other meshes for soffeeent female issues.
So even a smaller step then I anticipated.
apparently they reclassified this type of mesh the one that was banned as a class 3 which has to meet stricter standards. I imagine hernia mesh is only a class 2. So I guess until real change happens it might have to be reclassified for any real reform to happen. -
Thank you for this news. Could you tell us what countries were in the forefront of this, ahead of the US? [… slow to act compared to other countries the US seems to finally have taken action.]
Very interesting considering the companies active as suppliers (Johnson & Johnson, etc.). -
Thank you for the posting. Also, please elaborate on the slowness of the US to deal with the matter. I would like to find out what countries were in the forefront. It is rather ironic that the US is a major producer (e.g. Johnson & Johnson) of the devices.
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