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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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.


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