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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Showing posts with label the Sunday Mail. Show all posts
Showing posts with label the Sunday Mail. Show all posts

Tuesday, September 8, 2015

Medical device industry: "rotting from the inside out".


‘I’m rotting from the inside out’: woman tells of vaginal implant gone wrong

September 5, 2015 9:00am
Rhian DeutromThe Sunday Mail (Qld)

A BRISBANE woman whose body rejected a controversial pelvic implant at the centre of a class action has spent the past decade in agony.

Dee Nelson, 46, has been fighting for specialists around the country to address severe complications caused by a common vaginal implant.
While the mother-of-two looks perfectly healthy, she believes the tension-free vaginal tape sling, distributed by Johnson & Johnson Australia, is slowly killing her.

Ms Nelson received the implant in 2005 for weak pelvic muscles following the birth of her daughter. Two weeks later, she was rushed to the emergency department with heavy bleeding and a high fever.
According to Ms Nelson, her body rejected the implant but no one would believe her. Doctors told the mother her symptoms were “all in her head”, and at one point, a psychiatric assessment was suggested.

“I knew what the problem was, as did millions of other women across the world, but no one would listen,” Ms Nelson said.
“These people were playing with my life, but if I went back and said there was something wrong, they just wiped their hands of me.
“I have been handed around the system from one specialist to another, and in the meantime, women are dying from these foreign objects inside them.”
For the next 10 years, Ms Nelson’s health rapidly deteriorated as her nerves and muscles grew through the plastic implant, wreaking havoc with her confidence.
“I have aged so much, and I’m in constant pain,” she said.
“I can’t hold down a job, eat during the day or stand up for long periods … I feel like I’m 90 years old. It’s horrific.”
Surgeons around the country have refused to remove her implant as it has been inside her for too long.
Ms Nelson said the side effects have taken a significant toll on her family as well.
“When my children were young and needed me, I couldn’t be there for them because I was in agony,” she said.
“They have had to watch me deteriorate … it’s devastating.”


For Ms Nelson, even the thought of having sex with her husband was painful.
“I have a beautiful partner who I have been married to since I was 16 years old, but I can’t love him and he can’t love me,” she said.
“To go through life without love and not be a woman isn’t right.”
Ms Nelson is one of about 40,000 Australian women who received mesh implants before they were withdrawn from sale in 2012. Shine Lawyers’ class actions solicitor Bridget Cook told The Courier-Mail a lawsuit was filed against distributor Johnson & Johnson Australia and manufacturer Ethicon in 2012 on behalf of 400 women who suffered the devastating side effects.
“We allege the products were introduced without any pre-market testing … the implants were not fit for their purpose, Ms Cook said.
A spokeswoman for Johnson & Johnson Australia said the company was “always concerned when a patient experiences adverse medical events”.
She said Ethicon is “vigorously defending” all lawsuits concerning the allegedly faulty implants.
“We are confident the evidence will show that Ethicon acted appropriately and responsibly in the research, development and marketing of its pelvic mesh product s.
“We have made patient safety a top priority, and will continue to do so,” the spokeswoman said.
While the lawsuit inches closer to a trial, Ms Nelson remains housebound, praying to regain control of her life. Her only hope is to travel to the US to undergo $40,000 surgery to finally have the mesh removed.

Knowing what I know now, I would never have gone through with it … It’s rotting me from the inside out,” she said.
http://www.couriermail.com.au/news/queensland/im-rotting-from-the-inside-out-woman-tells-of-vaginal-implant-gone-wrong/story-fnihsrf2-1227514296507

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. #
Learn More:
Facebook Scottish Mesh Survivorshttps://www.facebook.com/karen.neil.16503

http://meshmedicaldevicenewsdesk.com/media-reports/transvaginal-mesh-warnings-to-be-strengthened-in-scotland-at-the-urging-of-mesh-injured/


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.