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Need to Know: March 22, 2012: Medical devices

This week “Need to Know” medical correspondent Dr. Emily Senay examines whether the Food and Drug Administration’s medical device review process is adequately protecting the public. While the vast majority of these devices are safe and effective, according to the U.S. Government Accountability Office (GAO), hundreds are recalled every year. And the impact of an unsafe device can be devastating.

Plus, anchor Jeff Greenfield interviews Dr. Josh Rising, project director of the Medical Device Initiative at The Pew Charitable Trusts.

Read the show transcript.


Medical devices: Statements and documents

Read statements from the FDA and ETHICON to Need to Know, the original brochure for the ETHICON PROLIFT device and reports from the Government Accountability Office.

Dr. Josh Rising

Dr. Josh Rising is Project Director of the Medical Device Initiative at the Pew Charitable Trusts.  One of its goals is to improve the tracking of the safety of medical devices on the market.

Web exclusive: Coping with chronic pain

In this web exclusive, Linda Gross speaks to Need to Know medical correspondent Dr. Emily Senay about how she deals with her chronic pain, compounded by feelings of anxiety, frustration and isolation.

ProPublica: Four Medical Devices That Escaped FDA Scrutiny

Delve into ProPublica’s investigation into surgical mesh, hip implants, heart valve rings and defibrillator leads.

F.D.A. Whistleblowers

Read more about the internal disagreements over review processes at the F.D.A.

Watch more full episodes of Need to Know.



  • Jane Akre

    Thank you for raising the profile on this under-reported story that affects thousands!

  • George

    Thank YOU PBS – The medical device industry has taken a page from the NRA on how to manipulate the US Federal Government. The chemicals used in mesh medical devices is considered toxic to human according to the listed MDS – but is implanted in various areas of our bodies to the tune of over a million patients a year.
    Please help us to further expose this medical tragedy – George

  • terri

    why is that the main stream media hasn’t covered the medical tragedy of mesh?Women are sick,some have died,but yet very little coverage.You gotta go looking for it.Thousands of women ‘s life’s have been destroyed.Mine in particular……Oh yeah,I had a good life,damn good life.But Johnson and Johnson took it from me.Each day is worse than the day before . I am slowly dying and there is nothing that can be done.This is a battle that too many women are fighting because the FDA dropped the ball and let big pharma lie cheat a sorry ass product (vaginal mesh slings) into the medical market.I am angry for that I am sorry.I read all the horror tells.And know that there are so many others suffering .I just can’t figure out why this story is not 24/7.

  • Dayle McQueen

    I believe it is imperative that these medical devices are tracked. Every item I’ve ever purchased has a barcode. Not to be cynical but these medical devices are fast track so the pharmaceutical companies and medical equipment companies can make money; aka big busines. They should be happy to track these items so that it shows sucess rrates and faulure rates but that may give a factual basis n to prove negligence for lawsuits from people who have been implanted with faulty devices

  • OCTheo

    What is not discussed or even mentioned in this story is why are Americans sicker than the rest of the world. We are always on the look out for the next wonder drug or medical device. And with a federal agency as corrupt as the FDA, it is not a mystery to me that millions of Americans have been killed just by going to see a doctor; doctors who work for the medical industry, and not the public.

    This surgical implant can be avoided by these women by simply losing weight. When you are overweight, your overweight torso/belly pushed against your bladder. You do not have to be a doctor or an Einstein to know that. But everyone is just looking for something to cover up the mess he/she has gotten himself/herself into.

    Americans eat too much and exercise very little. We fight for the nearest parking space in front of McDonald’s or grocery store. Americans eat the worst of foods and drink too many sodas. Everyone is looking for the 1,000 channel cable deal, instead of getting off the couch and simply walk a mile or two.

    As much as I despise and lay full blame on these company executives who will sell their mothers for profit, the woman featured on this show and others like her, would not have experienced this agony, if they will only control what they eat and lose some weight.

    No medical device or magical diet will make you lose weight and stay healthy. Each one of us is responsible for our health, not the entrepreneurial doctors and their greedy merchants of death.

  • Terlin

    You do not know what the hell you are talking about. Open your eyes. My Brother was not over weight and at the prime of his life and developed an inguinal hernia from exercising to only have his life changed to nothing but severe pain for the last 2 years. People like yourself just turn my stomach with your stupid comments.

  • Chuck

    The problem with the FDA is the F. Federal as in government. What would make you think that the government has got your back. Don’t even get me started on the Affordable Health Care Act. I think if there to busy to study and review of these new drugs and devices that it be broken up. You have one separate group or identity to govern over each subject. One group studies drug and another does devices and so on. And every case it be led by competent doctors, researchers and scientists. Maybe even get colleges involved. You could possible even create an industry thru the college system that would further academia. I know a lot of schools do research but maybe we could do more by keeping this industry within our own borders. And that is the crucible that I bear. I had bilateral total hip replacement surgery 2 and a half years ago. I just had the metal on metal devices replaced because they where failing. I now suffer from severe Metallosis (to much metal in my system). The worst problem was that the company who makes these devices are in U.K. and Germany. The FDA allowed use of these devices in the U.S. with no studies or questioning of devices failure rate in there own countries. FDA…”F” stands for FAILURE.

  • btc

    It’s interesting this article doesn’t discuss Hong Kong, which has zero regulation on medical devices, yet somehow has a thriving healthcare market.

  • Nonie

    the FDA needs to seriously revamp their protocol for getting new products approved,,, any implant device needs to be classified as high risk just because of the nature of Foreign Body Reaction…reclassify all implant materials as class 3 devices that need more scrutiny……and make reporting of any complications mandatory!!!

  • RD Legal Funding

    This story is a perfect reason why people have to be vigilant in their pursuit for justice if there are deficiencies with medical devices. The medical device industry is a huge industry built partially on the profits it makes that people end up using. Many times if something is wrong with the products, the device makers will offer a low ball settlement to make the lawsuits go away. For anyone using medical devices or may use them its important to know the recall history of such items.

  • Art

    As a nurse myself, but one who takes care of myself, works out, eats healthy, and pays attention to developments in health care so that I can keep myself healty- what disturbs me is that she is possibly 50 pounds overweight- that excess weight is the cause of her rectal and vaginal prolapses- the human body was not, and is not evolved to cope with obesity. We can not continue to chase after so-called cures to treat a neverending horizon of ills that we bring upon ourselves.

  • Art

    Kudos. And I’ll add that, sad but true? We will ALL die. We need to stop implanting, transplanting, doing dialysis, and lap bands and stents and otherwise spending billions to try to save a few, while the masses either go without health care, or cannor afford basic health care. It s out of control, it cannot continue.

  • Jeff

    Art, OC Theo, I agree with you that there is a problem with obesity and that people need to take better care of themselves, but there is the real problem of people making decisions and opinions based on assumptions instead of facts. In this program she is 50 pounds overweight at the time of filming, which is over 6 years since she had the first of 22 surgeries. Before this she was very fit, since she has put on the weight trying to live and survive with the complications of having hundreds of mesh knifes and needles cutting and moving thru out the pelvic floor with every step or movement she takes. Try to imagine what it would be like just to try and have a normal thought process, with this taking place in your private area. Don’t imagine there would be to much time for fitness. It takes these woman all their strength just to try and endure the pain from just walking from point a to point b, not alone try to jog or run. Now for me being able to make these statements based on facts, I have watched her live with this horrific nightmare that she can not wake up from and believe me, there is no enjoyment in watching your wife of 28 years have to live like this!!!!

  • Art

    Point taken about her problem being before the weight gain. But every time I see all of these obese people getting lap band surgey, mesh implants, on and on it makes me cringe. None of these operations really work, in the end. They cause hellish complications.

  • Jeff

    I am glad that you are a caring person and it concerns you about the obese problem that we have in our country. I agree that people need to want to help themselves first, instead of looking for a quick fix. The main reason that women have these type of health problems, are from issues due to giving birth to their children, which your mother and mine could have experience. This story was about dangerous medical devices and how they are brought to market, and how manufactures use loopholes in government to fast track to market(510k), looking to put profit before safety. I see you are a nurse, which like Linda, would have patients of your own, who put their trust in you to give them the best care possible and that the medical devices you use are safe. The woman in this program was a medical professional for over 25 years and you cannot imagine the frustration she has in the negligence and the amount of trust that she has lost in the medical society. That only adds to the unbelievable pain that she lives with on a daily basis.

  • Art

    Health care in this country is a scam, and it will be until Obamace collapses the private insurance industry (which is the real, unspoekn goal of OC), and we become civilized like most modern countries. Doctors don’t give a damn about healing, and have no incentive to. Most nurses are lazy and incompetent, and you’d be sad to hear what they say about their patints as soon as they leave their rooms. Then again, if you are not one of the herd, and are genuine, compassionate, competent, etc.- sooner or later you’ll find that you better join the ‘crowd’. I’m sure Linda would say the exact same thing.

  • Tyler Anderson

    Sad story. This procedure/product should have never made it to the market.

  • James Falasco

    i could not agree more. Go to Europe or Asia and you will see women riding bikes to work and walking. Very few plus sizes. I drove by the local middle school the other day and was shocked to see the students out of “Phys Ed” They were walking around the track which is good but it was sad to seem the tummys on them