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, July 4, 2017

Johnson & Johnson Pelvic Mesh: Sell, Sell, Sell !!!! Profit over Safety.




Nine years ago Gai Thompson had a mesh implant that she said changed her life forever.
“The mesh destroys lives, it destroys you physically and emotionally,” Ms Thompson told reporters outside the court in Sydney.
Ms Thompson is one of the seven hundred women involved in one of the country's largest product liability class actions, taking on Johnson & Johnson and its subsidiary Ethicon.
“Today is their chance to be heard and seek justice for what was lost,” Shine Lawyers’ Rebecca Jancauskas said.
“This is about accountability and ensuring this never happens again.”
The mesh is used to treat common complications after childbirth, such as prolapse and incontinence.
Shine’s Barrister Tony Bannon SC told the court many of the women now live in excruciating pain due to inflammation and infection.

Some are unable to work or be intimate with partners, meaning their "enjoyment of life had been seriously compromised and dramatically altered for the worse."
The court heard Johnson & Johnson conducted an aggressive "tidal wave of promotion" towards surgeons, spruiking the procedure without conducting appropriate clinical trials.
Lawyers for the claimants say removing the implant is near impossible and "is a highly complex, life threatening surgery. Even if removed the pain and disability will continue."
The court heard patients weren't properly advised of the risks involved with the surgery, and that if they were they never would have gone ahead with it.
More than 100,000 women have started legal action against the pharmaceutical giant in the US, the UK and Canada.
Some of the products involved in the suit are still available to purchase.
“There’s too many women who are injured,” implant victim Joanne Maninon said.
“The pain, the complication, the autoimmune diseases. It’s lifelong. You don’t just have the mesh removed and then recover and go on with life. You’re damaged for life.
Johnson & Johnson says the products were developed in consultation with specialist surgeons and the majority of women had a positive result.
A statement from Johnson & Johnson said: “We have sold over 100,000 mesh products in the Australian market.
“We have been notified of fewer than 200 total product events. 67 of these product events were assessed as reportable to the TGA and Medsafe, in line with their requirements.
“It is always a concern to us when a patient doesn’t get the outcome they had hoped for, or believes they have experienced an adverse event.
“However it is important to remember that the majority of women who have undergone this surgery have had a positive result, and it has improved their quality of life.”

Their lawyers will give evidence next week.
http://www.sbs.com.au/news/article/2017/07/04/court-told-how-johnson-johnson-conducted-tidal-wave-promotion

2 comments:

  1. Sharing on Twitter, great article!!! Thank you

    ReplyDelete
  2. Why don't we test compatibility of mesh with body by implanting small portion first like they do in some countries besides usa??

    ReplyDelete