Haseeb 1

Bleeding Edge Response

Usman Haseeb
Loyola University Chicago
Professor Grendahl
November 19th, 2018
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Bleeding Edge Response

The “Bleeding Edge” is a documentary that highlights the negative externalities of the

advancement of medical technology over the years. Products like Essure are highlighted to

show how medical technology can very seriously impact lives. The documentary sheds light

upon the lives of the unfortunate women who used the product and suffered a variety of

horrific medical issues that followed. Different perspectives from doctors to patients to family

members are included to give different opinions on what the advancement of medical

technology has done to society. There is certainly a theme of mistrust and regret present in this

documentary. Some of the underlying storylines surrounding the regulation of these products

are discussed in length as well. The FDA is referenced several times for its responses to

different products and how despite their pushback, companies like Johnson & Johnson continue

to put out dangerous products. Overall, this documentary highlights the lack of quality and

quality improvement that is present in the healthcare technology sphere and in a way calls

upon changes to be made for the better.

Personally, the process and business of medical devices is very troubling. This

documentary highlights a substantial amount of what is wrong with it. There is not enough

regulation or reporting on the errors and this is a major reason for why the business is so

negative in my mind. For example, Essure had many issues but people did not really realize this

until too long after others used it. Reporting of issues with patents is very flimsy and not done

often enough as well. I think that the fact that reporting on medical devices is optional is a very

ill-advised decision and has very serious repercussions as seen in the documentary. The process

by which medical devices are distributed and put out in the public needs to be changed as well.

There is misleading information being spread and in some cases the approval for devices is
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Bleeding Edge Response

fueled by internal bias. There is no reason that a stakeholder in a company should have a hand

in the approval process. The business of medical devices is also problematic to me and I have

serious qualms with it. Companies like Johnson & Johnson and Bayer know all about how their

products are faulty but do not do enough to make people aware of it or make necessary

changes. These businesses are self-interested in making a killing and in some cases are actually

killing individuals. The business of medical technology lacks ethics and if this trend persists

nothing will change. After this documentary was released, Bayer announced they will stop

selling Essure at the end of 2018. This is an example of why it is important for there to be

pushback because it will lead to change.

In order to improve the pre-market approval process, one thing that could be done is

add constraints that slow down the process. This way, there is more diligent care given to the

product and it is not passed through without serious quality checks. An example of something

that should have had a quality check from the documentary is the hip technology device. It had

very large amounts of cobalt which is not healthy for humans in such a dosage and if further

research was done the negative effects highlighted in the documentary could be mitigated.

Another thing that could be done to improve the pre-market approval process is to limit

eligibility. For a company to be able to sell their products, they must go through stringent

checks and even background checks of other products before being allowed to spread it to the

market. This would go a long way to preventing the horrors that were exposed in this

documentary.