Week 3 EHTA and Bleeding Edge movie Flashcards
What are some words to describe the technology in the Bleeding edge?
- medical devices
- invasive
- improve QOL
- established
How would you describe the “Essure” technology in the Bleeding Edge?
- permanent birth control for women
- inserted into each fallopian tube
- no incisions required (non-surgical)
- promoted with rapid recovery
How would you describe Dr.Tower’s “cobalt metal on metal hip replacement” experience in the Bleeding Edge?
- believed to be good for active people
- over time, began to see neurological decline (tremors, repeating himself)
- had a psychological breakdown
- tested his blood and urine –> got Cobalt poisoning
- had to get a new hip –> saw huge improvements with plastic/ceramic one
- when they went to put the new one in the saw that the cobalt had liquified his hip capsule
What were they experiences of women who had “Essure” in the Bleeding Edge?
- led to severe health problems
- having to get mutiple surgeries (histerectomy, removal of device)
- some who became pregnant, most time baby died or cause health probs in the babies
- when removed, device would fragment
- device could move out of fallopian tube and cause problems elsewhere
- mood problems
- loss of jobs
- loss of husbands
- loss of a love life
- some women didn’t know they got it (thought they had their tubes tied)
- weren’t told the risks about Essure by doctors
What methods were used to evaluate these technologies in the Bleeding Edge?
- pre- approval from FDA (tested in humans, data is compiled, presented to scientists)
-510K pre-approval for FDA (has to show that the device made is equally sufficient to one that is already on the market) - one study, one small sample size
What were some of the flaws to the regulatory system?
- any medical device used before 1976 is grandfathered in so no regulation needed
- not as many getting tested each on their on with 510K pre-approval rules (daisy chain)
- if the original device is deemed dangerous, the predicate of that device can still be on the market
- conflicts of interest
- not enough people
- not stringent
- not thorough enough
- company does not need to report adverse events to FDA
- changed clinical trial question answers of patients (essure device)
- man who gave evidence to approve Essure owned stock in the company!
- underrepporting to FDA
Are cobalt hip replacements still on the market?
Yes
Is Essure still on the market?
no –> women who created the facebook group lobbyed against a governmental person to take it off
What is the difference between medical device regulation and Drug Regulation?
medical device
- go through PMA
- less stringent than drugs
- one study
-small sample sizes (>100 people)
Drug regulation
- do two clinical trials
- need large sample size
What did Dr.Towers experiecne lead him to do?
- test all his hip replacement patients for cobalt poisoning
- led to doing MRI and PET scans with patients who are having hip replacement probs and neurological changes
- believes lead to many misdiagnoses (psych probs but actually just their hip and cobalt poisoning)
What is reversibility?
get it in, see what happens
if its bad, get it out, improvements are visible
What were some Equity issues in the bleeding edge?
- race –> told that the bleeding and pain with Essure was because they were Latino
- Gender –> lots of doctors were men (did not see the problem it caused women)
- class/power –> doctors know everything and their patients who are affected know nothing
What is the importance of patient perspectives in the Bleeding edge?
- to see the problems that are going wrong with the device so they can improve and save lifes
Does it take a lot of evidence to remove a device than it did to insert a device as per Dr.Tower?
YES!
