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I put this on another thread and lost it on transfer duh !!!
Today I saw a documentary film called 'The Bleeding Edge" by two US journalists about the problems caused by implantable medical devices: those mentioned and documented were mesh used for pelvic repairs in women, an implantable sterilisation device called Essure , a robotic surgical operation machine (Da Vinci) and use of artificial hip joints ( The chromium metal on metal or metal on plastic ones).
The film interviewed patients including nurses and doctors who have suffered life-changing ill-effects from these devices whilst a shoddy FDA continues to allow their use.
The companies use a loophole created by the US senate to get their devices approved by piggy-backing on similar devices approved in the past, without full testing and safety checking of these new devices.
The Trump administration has appointed a new Head of FDA who is a former administrator in a number of companies in the Medical Device industry.. The film asserts that the industry is more influential than even Big Pharma there.
"The Bleeding Edge" is heart-rending and the first time I have cried over something in a long time. The documentary is factual, shows both sides - the industry and its promotion of 'life-saving innovation' , the sufferers with their now thousands of participants on social media and the spread of this movement to other countries where these devices have been used and people are now suffering also.
Litigation has started in the US and the millions in payouts might explain why a certain US pump manufacturer stopped making its insulin pumps fairly recently.
Very soon after the film was released here Essure was removed by the company from sale here (off the register in Feb 2018).
The problem with chromium poisoning from artificial hip joints led to massive re-placement if hip joints here and litigation.
Pelvic Mesh clinics have been set up in each State and Territory here to assist women who have suffered ill-effects.
The fate and support for others suffering effects of mesh implanted for hernia repairs still needs to be addressed.
In Australia it took 17 years from when reports of problems began surfacing in USA and Australian women began pressuring for action before mesh for use in pelvic operations was banned (in 2017).
The problem here is the fact that it is not mandatory for doctors and hospitals to report adverse events related to implantable devices and the Therapeutic Goods Administration (TGA) who is supposed to approve the safety and use of these devices.
In my book it is a failure of the health system and its players and Government bureaucracy to do what is legislated and what is caring and part of being health professionals with care of patients uppermost.
I cannot of course speak for other countries outside the US but knowing human nature I would urge caution about believing what
assurances are given about devices' safety and approval ratings.
Why do I raise this?
We have heard in recent years about implantable devices to measure BSLs, and pumps to deliver insulin/glucagon etc.
Most if not all are from the US - how sure can we be that they have been properly tested and approved.?
For example, at least one manufacturer of externally-worn insulin pumps has been sued for unsafe pump malfunctions in the past.
Today I saw a documentary film called 'The Bleeding Edge" by two US journalists about the problems caused by implantable medical devices: those mentioned and documented were mesh used for pelvic repairs in women, an implantable sterilisation device called Essure , a robotic surgical operation machine (Da Vinci) and use of artificial hip joints ( The chromium metal on metal or metal on plastic ones).
The film interviewed patients including nurses and doctors who have suffered life-changing ill-effects from these devices whilst a shoddy FDA continues to allow their use.
The companies use a loophole created by the US senate to get their devices approved by piggy-backing on similar devices approved in the past, without full testing and safety checking of these new devices.
The Trump administration has appointed a new Head of FDA who is a former administrator in a number of companies in the Medical Device industry.. The film asserts that the industry is more influential than even Big Pharma there.
"The Bleeding Edge" is heart-rending and the first time I have cried over something in a long time. The documentary is factual, shows both sides - the industry and its promotion of 'life-saving innovation' , the sufferers with their now thousands of participants on social media and the spread of this movement to other countries where these devices have been used and people are now suffering also.
Litigation has started in the US and the millions in payouts might explain why a certain US pump manufacturer stopped making its insulin pumps fairly recently.
Very soon after the film was released here Essure was removed by the company from sale here (off the register in Feb 2018).
The problem with chromium poisoning from artificial hip joints led to massive re-placement if hip joints here and litigation.
Pelvic Mesh clinics have been set up in each State and Territory here to assist women who have suffered ill-effects.
The fate and support for others suffering effects of mesh implanted for hernia repairs still needs to be addressed.
In Australia it took 17 years from when reports of problems began surfacing in USA and Australian women began pressuring for action before mesh for use in pelvic operations was banned (in 2017).
The problem here is the fact that it is not mandatory for doctors and hospitals to report adverse events related to implantable devices and the Therapeutic Goods Administration (TGA) who is supposed to approve the safety and use of these devices.
In my book it is a failure of the health system and its players and Government bureaucracy to do what is legislated and what is caring and part of being health professionals with care of patients uppermost.
I cannot of course speak for other countries outside the US but knowing human nature I would urge caution about believing what
assurances are given about devices' safety and approval ratings.
Why do I raise this?
We have heard in recent years about implantable devices to measure BSLs, and pumps to deliver insulin/glucagon etc.
Most if not all are from the US - how sure can we be that they have been properly tested and approved.?
For example, at least one manufacturer of externally-worn insulin pumps has been sued for unsafe pump malfunctions in the past.
