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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Monday, July 30, 2012

Patient Harm From Implanted Surgical Mesh



Open letter to Surgeons who have implanted mesh

:
Each of you who blatantly disregarded your patients pain and suffering has broken the oath, “First, Do NO Harm.” You have harmed us many times over. And will continue to do so until you take the time to educate yourselves beyond what a pharmaceutical representative tells you.



What, exactly, did you KNOW about mesh before you advised your patient? Did you KNOW that is supposed to be permanent? Did you KNOW that mesh might not work well for everyone? Did you KNOW that mesh was inert, or that it wasn’t? Did you KNOW if mesh could shrink, curl and damage surrounding tissue as it moved? Did you KNOW if the patient would have a foreign body response to the mesh? Did you KNOW that a bad reaction might cause repeated infections and or bleeding? Did you KNOW what the possible complications were associated with blind insertion of mesh? Did you KNOW if the one-size-fits-all kits would work on every one the same, regardless of body type or size? Did you KNOW that nerve entrapment or injury was probable? Did you KNOW that if an adverse reaction to mesh occurred that the only way to alleviate the symptoms was to remove the mesh? Did you KNOW that the resulting pain of nerve injury and or reaction to the mesh would cause your patient to LOSE quality of life? Did you KNOW how many of your patients might die due to complications arising from mesh implantation? Did YOU know?

 If you didn’t you should have. If you did, you forgot to mention this to us. 

Failing to tell us any of that, how could you belittle us when we begged for help? Is there something written somewhere that this is due course when a patient comes to you for medical assistance? We came to you, as a person of trust, to help us find answers to why we were left in this horrible condition after an operation you claimed would lift our quality of life.

Instead of answers we had pieces of eroding mesh yanked and cut from our most private parts without any numbing agents. Then we were sent to pain clinics where we were given painful shots in our abdomens and sensitive pelvic areas, that gave little to no relief, and pelvic physical therapists who caused more pain. And when these actions didn’t alleviate our symptoms we asked if the mesh was the cause. Our question was not appreciated which resulted in our being disrespected, treated to eye rolls and told it was all in our head. In some cases you walked out on us, told us to leave or were physically and or verbally abusive. Yet many of us continued to believe in you even though, in our hearts, we knew different and have suffered needlessly because of it. 



Many, if not all of us, have been told we were the “only” patient who ever had problems. How can hundreds, thousands, tens of thousands (the total numbers are unknown) of people each be the ONLY one who has had adverse reactions to mesh? How many complications were you aware of but didn’t bother to mention because you were told they were rare and this was the GOLD STANDARD of treatment for POP, SUI and Hernia repair?

If you are finding many more patients than usual do not trust your advice it is because you have forced us to look beyond you, to look for answers you are either unwilling or unable to give. 

YOU are the doctor, the one who is supposed to know the medical answers and if you don’t then it is your job to find them.

It is not the patients responsibility to determine whether a product or drug is in their best interest, to know what is safe. That is YOUR responsibility, why you get paid the big bucks! Just because a representative of a pharmaceutical company says it’s so, doesn’t make it so. And just because the FDA has cleared a product through the 510(k) doesn’t mean that it’s safe for patient use. It’s time to go back to treating patients as human beings instead of quotas on the insurance gravy train .  
  .  and if you can’t or won’t then maybe it’s time for a new career.
 Jaye Lee       

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