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Scottish Medical Officer Says Docs Can Continue to Implant Mesh Despite Mesh Suspension

Marion Scott

Marion Scott

Marion Scott, the reporter who has passionately reported on the pelvic mesh issue for the Daily Record and Sunday Mail newspaper in Scotland, reports a top medical adviser to the Scottish government suggests doctors may continue to perform mesh implants even though the Health Secretary has advised use of pelvic mesh be suspended.

Dr. Frances Elliott is the deputy chief medical officer for Scotland. She sent a letter to doctors urging they continue to enroll women in a clinical trial and when warranted implant them with pelvic organ mesh to treat incontinence and pelvic organ prolapse.

scotland wants to contine with Mesh Implants

 

 

The Daily Record and Sunday Mail quotes Scottish Mesh Survivor Karen Neil, “This is a betrayal of everything we were promised, a cynical move to allow doctors to keep experimenting on women despite the devastating injuries we’ve all suffered.”

Last June, Health Secretary Alex Neil announced he backed a suspension of mesh sales pending a safety review after listening to the stories of women who had petitioned the government. See the back story here.

Scotland made headlines when it became the first country to suspend sales of transvaginal mesh and discourage its use after 328 mesh-injured women in the country came forward. according to the BBC, about 1,500 women undergo transvaginal mesh implant in Scotland every year.

By comparison, there are 67,000 pelvic mesh injury cases filed in federal court in the U.S. and many more in state court.

Mr. Neil encouraged Dr. Elliot to write to the health boards to suspend the use of transvaginal mesh until there is a Scottish review, however she reportedly had a different message.

A European Commission investigation into mesh implants is already underway and is due to be released January 2015 (here), the same time an FDA review of the health of implanted women is due in January from 30 mesh manufacturers.

The actual number of mesh injured women in Scotland and around the world is not known because there is no tracking,  either by the FDA or by industry, of mesh-related complications that can include infection, mesh erosion and migration, nerve damage and chronic pain, among other problems. Any reporting to the FDA is entirely voluntary and not closely monitored.

Many doctors followed that advice fearing the risks outweighed the benefits.

Learn More:

Read the rest of the story here.

Page One – Sunday Mail, June 22, 2104 –  “Cheers and Tears as Health Secretary Suspends Operations”

Page Two – Sunday Mail, June 22, 2014 –  “Health Secretary on Why He Suspended Mesh”

Watch the entire hearing on BBC Democracy Live here. 

Scottish Petition Here.

8 Comments

  1. Marie says:

    This makes me sick to my stomach! Was Dr. Elliot payed off? Was she threatened with loss of revenue lawsuit by manufactures? Was this decision made after the vote for independence? Maybe all these things are connected. And fourth more, how convienant that two studies will be released in Jan. All of us were test subjects and were not notified that we were part of clinical trials by our doctors and that should be criminal!

  2. Kitty says:

    Does anyone know wbout Maristem Matrix for pelvic organ prolaspe and the investigational trial that is going on?

  3. msm says:

    You can bet the American Urogynecologic Society (supported by manufacturers) was the primary influence. They have the loudest voice in the International Urogynecological Association.

    Continued use while FDA-ordered studies and reviews are incomplete is unethical to say the least. In the U.S., AMS started 2 major studies with plans on enrolling nearly 1000 women total. I would like to know how these “studies” are being conducted. What information/education is given to the study participants? What consent documents are they signing?

    Can the studies produce reliable results? To do so, there has to be a control group. It cannot be double-blind. I don’t see how it could be single-blind which would require the subjects would have to subject themselves to surgery not knowing if mesh or native tissue will be used. How will a control group be established? Will these really be evidence-based studies? No. The only objective measures are those of clinically measured incontinence. Other measures are subbjective and time-sensitive.

    These studies rely on self-reports of incontinence, sexual function, pain, and activity. What will the dropout or exclusion rate be? Past studies have show less than 50% of subjects completed the studies and the exclusions have been for a long list of study-defined causes. Unless a respectable percentage of subjects are folloed for 5-10 years, the study results are not reliable. Outcomes for 1-2 yrs. are inconclusive at best and may be skewed because of the “honeymoon” period some experience with continence before the pain and complications are experienced. Results for 1-2 years insinuate that there as a “warranty” implied when a patient submits to surgery. I’ve never heard, “Sign this release and we’ll implant you with a device that might work for 12-18 months. We are not liable for anything beyond that.”

    The FDA has ordered POST-MARKET SURVEILLANCE studies. Surveillance means observation of those who have received the device, not new implantation and then observation. This is giving the manufacturers a license to harm. The FDA told them to do these studies and are allowing implantation of the product in question. The manufacturer conducting the studies will be free from liability because they are only carrying out the FDA’s demands and the FDA is approving the methods used. The patients who will be harmed by the study will have no recourse because the FDA can’t be sued.

    Any country who will allow or promote the use of any device that has done harm and has not been appropriately studied independently to include objective data beyond 5 years, is a country that does not value the life of their citizens. Perhaps it is just women and hernia sufferers that aren’t valued and are seen as disposable subjects that should be euthanized like lab rats after a bad outcome. How else can it be justified to allow continued implantation when juries in multiple trials have found the devices to be defective and harmful?

    You can bet money is the motivation. The surgeons in the U.S. and Scotland will lose a lot of money if mesh use is suspended or banned. Endo (parent company of AMS) allowed their registration to sell, import, export, or manufacture to expire and can no longer market mesh in Australia. Yet it is AMS that is conducting these to large studies. AMS is up for sale and the women’s health division is rumored to be struggling with layoffs of sales staff. Its future is unknown and yet they are currently enrolling women in these studies.

    Didn’t mean to bring it all back to the U.S. but this is where it starts. Come to think of it, Endo is based in Dublin. hmmmm…. just an aside.

  4. Dean says:

    Don’t get it they make the right decision by taking it of the market there now they want to go ahead and put it into others then maybe down the road someone has to take it out of the person who had it put in.I can see law suits in the future against Drs who put this into people there.

    • Jan Urban says:

      What is wrong with this Doctor. Has she not seen what damage this device causes? It’s permanent! It’s not like a pacemaker, lens for cataracts, knees, hip replacements. This is a disastrous device from HELL! DO NO HARM! She needs her license to practice medicine REVOKED! I am sure she had access to a lot of information regarding these Mesh Devices and to advise Doctor’s to continue using this Mesh is beyond my comprehension.

  5. heart broken says:

    mesh sufferers like myself. who have been cheated out of our say, because of legal issues, and have been threatened by a large company they will sue . there shoudnt be a time frame for clinical negligence a lot of Drs worldwide are ignorant to the true facts or don’t want to be involved, everything is all about money. I want my day in court, will I get it God Only knows. but I am still hurting and very frustrated by the whole issue.because I nearly lost my man and my mind.

  6. Mary pat says:

    Dr Frances Elliott was obviously paid off. She is a rotten cancer in Bonnie Scotland. Someone should put mesh in her!

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