Joint replacements are the #1 expenditure of Medicare. The process of approving these medical devices is flawed according to the Institute of Medicine. It is time for patients' voices to be heard as stakeholders and for public support for increased medical device industry accountability and heightened protections for patients. Post-market registry. Product warranty. Patient/consumer stakeholder equity. Rescind industry pre-emptions/entitlements. All clinical trials must report all data.
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Wednesday, October 2, 2013

Scotland takes action: patient harm from surgical mesh.

Oct 1st, 2013 | By Jane Akre | Category: Media Reports FiDA highlight and comment below

The Sunday Mail

Scotland is making changes in the way the public is warned about transvaginal mesh.
The Scottish Parliament set up a transvaginal mesh working group in May 2013. Last week the TVM working group met with the Minister for Health and Well Being.
Scotland’s Health Minister Alex Neil has ordered the National Health Service to warn women about transvaginal mesh surgery after a series of reports in the Sunday Mail about the “horrific complications” suffered by hundreds of patients.
“Officials will produce revised consent forms and information leaflets within two weeks. The move follows our campaign revealing how women have been crippled and maimed by polypropylene mesh implanted during surgery meant to help bladder and prolapse problems.”
Mr. Neil made the announcement with five mesh victims and vowed that all health boards will be asked to use these new forms. A leaflet will be given to all women considering surgery with mesh. The Sunday Mail reports it has received contacts from more than 300 people who tell “how their lives were destroyed by the implants.”
Ironically there have been only six reports of complications by doctors in Scotland to United Kingdom’s version of the FDA, the Medicines and Healthcare Regulatory Agency.
Neil says “clearly the system isn’t working. Doctors aren’t compelled to report adverse incidents to the MHRA.”
Anti-mesh campaigners are calling for an implant register to record procedures involving implantable medical devices such as mesh, breast implants and hip replacements. The European Union was recently rocked by the PIP breast implant scandal where a French manufacturer was using industrial grade silicone to fill breast implants. The government has had to step in and pay for implant removal surgeries.

Drs. Raz, Margolis Help
Dr. Michael Thomas Margolis of Bay Area Pelvic Surgery and Dr. Shlomo Raz, a urologist from UCLA added their comments to the proceedings. Dr. Margolis wrote a letter to Minister Alex Neil and DR. Raz commented by email.   Here is the letter.
Dr. Margolis is a surgeon in the area of female pelvic reconstruction. He’s been removing mesh implants since the mid 1990’s and now removes two a week. He reports complications include injuries to the bladder, bowel, blood vessels and vagina.
He told the parliament he’s treated “patients with vaginal mesh erosion, chronic complications of mesh including chronic infection, chronic scarring, chronic pain, morbid disfigurement and loss of function of the vagina.”  Many marriages are ended by the mesh issue, he says.
Dr. Raz reported that partial mesh removals do not work for pain “It must be removed completely. Ultrasound is the only test that shows mesh. No other imaging will show it.”
“In the last 6 years we have removed more than 500 mesh complications. 70% of the patients are improved or cured while 30% are permanent disabled from the mesh including vaginal pain, leg pain, pain during intercourse. We remove all the mesh. This is the only hope for patients with complications from mesh,” Dr. Raz wrote in an email.
The working group in Scotland is making positive progress, say advocates, as are colleagues in England that recently met with Lord Howe at Westminster in London. #
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Joleen Chambers says:
Bravo Scotland! Valuing harmed patients and validating their stories by direct corrective action will save lives and the healthcare budget of your nation. In the U.S. the overly entitled medical device cartel is now holding our country hostage in a budget funding shut down to force changes in the Affordable Care Act to eliminate the paltry 2.3% tax. The U.S. FDA was the gold standard of regulation until it was infiltrated by industry influences, defunded to a level of irrelevance and ignored by legislators that could have progressively adapted laws to reflect the advancement of profiteering by this industry and updating the FDA/CDRH charter.

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