JEFF GREENFIELD: Welcome to Need to Know. Thanks for joining us. This week, we begin by posing a question: is the federal government doing enough to protect our safety? Not from crime or terrorism but from the very real dangers of some medical devices cleared for use by the Food and Drug Administration. While the vast majority of these devices are safe and effective, the Government Accountability Office reports that hundreds are recalled every year. And the impact of an un-safe device? It can be devastating.
Later, you’ll hear what other countries do to help their citizens learn about defective medical devices as early as possible. But we begin with the story of a woman in South Dakota, actually a nurse, who assumed the medical device implanted in her was safe – and who has suffered the consequences. Need to Know’s Medical Correspondent, Doctor Emily Senay, reports.
LINDA GROSS: I was active, very independent.
LINDA GROSS: – We did a lot of camping outdoors– walking, hiking– fishing.
DR. EMILY SENAY [narration]: LINDA GROSS’S FAMILY AND FULL TIME JOB AS A NURSE KEPT HER ON THE MOVE, BUT ALL THAT CHANGED ABOUT SEVEN YEARS AGO. SHE WAS HAVING PROBLEMS URINATING AND DEFECATING. AFTER SEEING A DOCTOR LINDA WAS DIAGNOSED WITH PELVIC ORGAN PROLAPSE, WHICH MEANT HER RECTUM WAS PUSHING INTO OTHER PELVIC ORGANS. IT’S a condition hundreds of thousands of women face.
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HER DOCTOR RECOMMENDED A NEW minimally invasive SURGICAL PROCEDURE said to come with few complications. IT INVOLVED SURGICALLY IMPLANTING MESH INTO LINDA’S PELVIC AREA. THE PRODUCT AND PROCEDURE – CALLED PROLIFT – WAS DEVELOPED BY ethicon, a WHOLLY OWNED SUBSIDIARY OF JOHNSON AND JOHNSON. but LINDA did have SOME concerns.
LINDA GROSS: I asked, “What do you do if a person’s body rejects,” and I was told you go in and remove it. Nothing in the brochure indicated that it was a permanent placement, that they cannot go in and get it completely.
DR. EMILY SENAY: And– and you were told specifically they could.
LINDA GROSS: Exactly.
DR. EMILY SENAY [narration]: AS PROMISED, THE SURGERY WAS QUICK AND LINDA WENT HOME THE NEXT DAY. BUT IT WAS TAKING LONGER THAN SHE HAD HOPED TO GET BACK TO HER NORMAL ROUTINE.
DR. EMILY SENAY: So after you had the surgery when did you really start to realize that it hadn’t worked out the way you’d hoped?
LINDA GROSS: The first indication was the severe pain that I had after surgery.
DR. EMILY SENAY: How soon after surgery?
LINDA GROSS: Immediately.
DR. EMILY SENAY: So immediately after surgery, you began to have problems?
LINDA GROSS: I couldn’t sit. It took– I believe 15 days for my bladder to restart– on its own again.
DR. EMILY SENAY [narration]: LINDA SAYS THE PAIN EVENTUALLY BECAME UNBEARABLE – LIKE NEEDLES CONSTANTLY STABBING HER PELVIC ORGANS. SHE COULDN’T GO TO WORK. AT HOME, SHE WAS UNABLE TO DO SIMPLE TASKS LIKE WASHING THE DISHES. THE ONLY RELIEF, SAYS LINDA, WAS TO LIE IN BED WITH HER LEGS PROPPED UP.
SO FIVE MONTHS AFTER HER OPERATION, SHE DECIDED TO HAVE THE MESH REMOVED. BUT BY THAT TIME HER TISSUES HAD BEGUN TO GROW IN AND AROUND THE MESH. DESPITE BEING TOLD, SHE SAYS EXPLICITLY THAT THE MESH COULD BE REMOVED, DOCTORS HAVE BEEN ONLY ABLE TO REMOVE PARTS OF THE MESH. PIECES OF IT REMAIN INSIDE HER TODAY.
LINDA GROSS: I’ve had 22 surgical procedures done. And I can tell you that when the mesh that has been removed is– it has to be cut out like bubble gum in your hair.
EMILY SENAY: You know, some people might say, “Well, you know, you’re a nurse. You– you have a more sophisticated level of training than the average woman.” Didn’t your nursing training teach you to be a little suspicious? Weren’t you– leery of new things that– that come on the market?
LINDA GROSS: Yes, you know, I um. I as a nurse looked at it as a patient perspective and– and– and went with it. Ver– I felt very confident when I went in.
EMILY SENAY: What has this meant for your family?
JEFF GROSS: Oh, it’s– it’s been huge. I– it’s just been a devastation, the family. We do not have the quality of family, the life that we used to have.
DR. EMILY SENAY [narration]: LINDA SAYS SHE AND HER HUSBAND JEFF CALLED THE MANUFACTURER AT LEAST FIVE TIMES SEEKING HELP BUT SAYS THEY GOT NONE. SO THE COUPLE HIRED AN ATTORNEY AND DECIDED TO SUE ETHICON AND JOHNSON AND JOHNSON.
THE COMPLAINT ALLEDGED THAT ETHICON AND JOHNSON AND JOHNSON WERE LIABLE FOR THE MESH KIT’S “DEFECTIVE DESIGN, MANUFACTURE, WARNINGS AND INSTRUCTIONS”…WHICH LED TO LINDA’S “PERMANENT PAIN, SUFFERING AND DISABILITY”. THE COMPLAINT ALSO ALLEDGED THAT JEFF TOO HAD BEEN “DEPRIVED OF THE ASSISTANCE, COMPANIONSHIP AND CONSORTIUM OF HIS WIFE.”
DR. EMILY SENAY: What– what was the problem with the device from Johnson & Johnson that Linda got?
ADAM SLATER: The primary problem is it was a terrible idea.
DR. EMILY SENAY [narration]: ADAM SLATER IS LINDA’S ATTORNEY. HERS IS ONE OF NEARLY 24 hundred CASES THAT HAVE BEEN BROUGHT AGAINST ETHICON AND JOHNSON AND JOHNSON ABOUT THEIR PELVIC MESH. other pelvic mesh manufacturers ARE FACING ANOTHER TEN THOUSAND LAWSUITS.
SOT: This is insidious, and dangerous..
WHAT SLATER SAYS HE FOUND IN DISCOVERY WERE DOCUMENTS PROVING THAT THE COMPANY KNEW THAT THERE WERE UNACCEPTABLE RISKS BUT PROCEEDED TO MARKET THE MESH ANYWAY.
ADAM SLATER: Two months before it was marketed, the person who helped develop it wrote a warning. A warning for sexually active women. And this went up the chain it was decided, “Oh, we’ve already printed those warnings. So we’re not gonna print ‘em again.” So in order to save the time and effort and money, they said, “Well, we’ll just warn later.” This got lost in the shuffle. This warning never got into the warnings.
DR. EMILY SENAY: This specifically warned doctors that sexually active women had a potential for real problems–
ADAM SLATER: Yeah. What–
DR. EMILY SENAY: –down the line.
ADAM SLATER: –they were telling them is, “Look, if this goes bad and you’re a sexually active woman, you’re gonna have a very serious problem with your quality of life.”
DR. EMILY SENAY: So the– the product went on the market. And eventually Johnson & Johnson starts to hear from physicians who are using it. What– what were they hearing?
ADAM SLATER: They’re hearing that a patient who had a Prolift ended up with a permanently destroyed vagina. They heard that another woman who had pain– constant pain starting two weeks after her surgery with the Prolift, “If you have to return for surgery to deal with a bad Prolift, it will be a disaster.” They also started hearing that women were having urinary retention. Long-standing, unresolvable. And it was pointed out that, “If this starts getting reported, it will scare the daylights out of doctors.”
DR. EMILY SENAY: Are we on the cusp of seeing something very, very big here in terms of numbers? Women affected and—
ADAM SLATER: Well, you already– forget about the cusp. It’s already happened. There are thousands of women who are suffering and having problems. There’s thousands more that are going to, unfortunately.
ADAM SLATER: They didn’t understand what was gonna happen to the mesh. They just ignored these things and ran with something called speed to market. They were racing another manufacturer with a similar idea and they wanted to get to market.
DR. EMILY SENAY [narration]: JOHNSON AND JOHNSON AND ETHICON DECLINED TO TALK TO NEED TO KNOW ON CAMERA. THOUGH THEY DISPUTE HIS FIGURES, SLATER SAYS HE’S OBTAINED INTERNAL DOCUMENTS THAT SHOW THE COMPANY MADE MORE THAN 108 MILLION DOLLARS IN SALES FROM THEIR MESH KITS BETWEEN 2005 AND 2012.
SO HOW DID THE PRODUCT GET TO THE MARKET IN THE FIRST PLACE?
KEEP IN MIND, THE FOOD AND DRUG ADMINISTRATION, WHICH OVERSEES ALL MEDICINE AND MEDICAL DEVICES, ALLOWED IT TO GO TO MARKET.
SOME DEVICES DEEMED TO BE HIGH RISK LIKE HEART VALVES, GO THROUGH YEARS OF CLINICAL TRIALS AND MANUFACTURERS MUST SUBMIT THAT DATA TO THE FDA. BUT THAT’S TRUE FOR ONLY TEN PERCENT OF LOW TO MODERATE RISK DEVICES.
ETHICON SAYS ITS DEVICES LIKE PROLIFT – WHICH IS CATEGORIZED AS LOW TO MODERATE RISK – ARE “AMONG THE MOST STUDIED” FOR CONDITIONS LIKE LINDA’S.
MANUFACTURERS OF LOW TO MODERATE RISK DEVICES FILL OUT FORMS TRYING TO PROVE TO THE FDA THAT THEIR NEW DEVICE IS “SUBSTANTIALLY EQUIVALENT” TO A DEVICE ALREADY ON THE MARKET. DURING ITS REVIEW PROCESS, THE FDA ROUTINELY ENGAGES THE COMPANY IN A DIALOGUE BEFORE CLEARING THE DEVICE.
GREG CURFMAN: [It] does nothing to ensure the safety or the effectiveness of the device. That’s not what it does. It simply compares it to an old device.
DR. EMILY SENAY [narration]: DOCTOR GREGORY CURFMAN IS THE EXECUTIVE EDITOR OF THE NEW ENGLAND JOURNAL OF MEDICINE AND HE’S WRITTEN ABOUT HOW LOW TO MODERATE RISK MEDICAL DEVICES GET ON THE MARKET.
GREG CURFMAN: They should have undergone more testing to ensure safety and effectiveness but slipped through the cracks.
DR. EMILY SENAY [narration]: FOR INSTANCE, JOHNSON AND JOHNSON’S PELVIC MESH TRACES ITS LINEAGE BACK TO VARIOUS MESH PRODUCTS DATING BACK DECADES. BUT ONE OF THOSE PRODUCTS WAS RECALLED IN 1999. AFTER REPORTS OF INJURIES. Curfman says examples like this show why a more thorough review process of medical devices is needed.
GREG CURFMAN: Too many balls have been dropped. I think that there are too many of these complex devices that have made it to market without clinical testing. They really shouldn’t be put out on the market to be put into large numbers of people until they’ve undergone adequate safety testing. And that requires clinical testing. So there’ve been too many– too many accidents. And I think that the system needs to be tightened up so that we stop these accidents from happening.
DR. EMILY SENAY: You don’t see a problem here?
DAVID NEXON: The whole device review process, produces devices that are overwhelmingly safe and effective for the American people.
DR. EMILY SENAY [narration]: DAVID NEXON IS THE SENIOR EXECUTIVE VICE PRESIDENT OF ADVAMED – A TRADE ASSOCIATION THAT REPRESENTS MEDICAL DEVICE MANUFACTURERS. HE SAYS A SPEEDY REVIEW PROCESS OF DERIVATIVE PRODUCTS IS CRUCIAL BECAUSE THE FDA LOOKS AT NEARLY FOUR THOUSAND NEW DEVICES EVERY YEAR – EVERYTHING FROM X-RAY MACHINES TO LASER SURGICAL DEVICES.
DAVID NEXON: It allows you not to start from scratch with each product, but to look at each– you know, look at the piece that’s actually changed. So you can innovate much more rapidly. And in an industry where there’s tremendous amount of rapid innovation in improvement products with a life cycle of about 18 months for a typical product, that’s a terrific way to keep innovation moving quickly, while protecting– the health and well-being of the American people.
DR. EMILY SENAY [narration]: IN 2011, THE FDA COMISSIONED A REPORT FROM INDEPENDENT MEDICAL EXPERTS ABOUT ITS CLEARANCE PROCESS FOR LOW TO MODERATE RISK DEVICES. THE EXPERTS CONCLUDED THAT THE PROCESS WAS “FLAWED” AND RECOMMENDED THAT THE FDA COME UP WITH AN ENTIRELY “NEW FRAMEWORK.”
DESPITE THE FINDINGS, THE FDA LATER ISSUED A RESPONSE SAYING THAT ITS CLEARANCE PROCESS should “not be eliminated.”
DR. EMILY SENAY: A number of– you know, thinkers in medicine say that it’s really a loophole that– manufacturers use to– to rush products to market without appropriately–
DAVID NEXON: That’s– that’s–
DR. EMILY SENAY: –safety testing.
DAVID NEXON: That’s fundamentally wrong. It’s not a loophole. It’s a way of dealing with a particular class of products that are low or moderate– moderate risk.
DR. EMILY SENAY: Well, except a lotta people say, the complexity and the– risk has gone way up. We need get something entirely different in place.”
DAVID NEXON: For those who say, “Well, we ought to throw out and replace it,” the answer is we’ll replace it with what? And when you actually ask those people, the only thing that they come up with is, “Well, we should– everything should be required to have controlled clinical trial, just like a drug before it can go on the market.” But it would have a devastating effect on people’s– ability to get new products. And the FDA couldn’t handle it. Can you imagine the FDA being able to deal with 4,000 products a year if they had to go th– or the– or the manufacturers creating such products, if they had to go through the– you know, the expense and time and– and cost and delay of a full-blown clinical trial where it wasn’t necessary.
DR. EMILY SENAY: So how do you explain something like surgical mesh– which is now turning into what could be a very large public health problem. How does your industry make sure that doesn’t happen?
DAVID NEXON: Well, I can’t speak to the specific product. That’s really something you need to talk to the company and the FDA about.
DR. EMILY SENAY [narration]: NEXON SAYS THAT THE FDA’S REGULATORY PROCESS ACTUALLY NEEDS TO MOVE FASTER. HE SAYS DEVICE MANUFACTURERS HAVE SEEN A DECLINE IN THE FDA’S PERFORMANCE AND LONGER REVIEW TIMES, CREATING WHAT HE CALLS A “DRAG” ON THE INDUSTRY.
DAVID NEXON: There are things that are in the pipeline that are not getting to people as quickly as they should. We’d like ‘em to move along faster.
GREG CURFMAN: It’s all well and good for– the industry– to preach innovation and the importance of innovation and the importance of speeding products to market and getting these things to patients. The industry also has a responsibility to put safe products out there. It’s their responsibility to ensure that their products are safe. So– it’s– it’s wonderful to talk about innovation. They also must talk about safety in the same breath.
DR. EMILY SENAY [narration]: THE FDA DECLINED AN ON-CAMERA INTERVIEW BUT SENT A STATEMENT THAT SAID….“while the majority of these medical devices perform well and improve patient health, medical devices carry a certain level of risk”….“we are continuing to identify ways to more quickly identify poorly performing devices and share information.”
LINDA’S CASE EVENTUALLY WENT TO COURT. AND IN FEBRUARY A JURY IN NEW JERSEY FOUND THAT THE MESH PRODUCT WAS NOT DEFECTIVELY DESIGNED. BUT THE JURY CONCLUDED THAT THE MANUFACTURER HAD MADE A FRAUDULENT MISREPRESENTATION TO LINDA AND FAILED TO PROVIDE ADEQUATE WARNINGS TO HER SURGEON.
SHE WAS AWARDED ELEVEN POINT ONE MILLION DOLLARS IN COMPENSATORY AND PUNITIVE DAMAGES. THE MANUFACTURER ISSUED A STATEMENT THAT IT WOULD APPEAL THE VERDICT.
IT ALSO TOLD NEED TO KNOW…“Profits were not put ahead of patient safety.” AND THAT the product…“Compared to other surgical options…was less invasive, reduced the number of days patients spent in the hospital and decreased the overall recovery period.”
DR. EMILY SENAY: Don’t we want people like Johnson & Johnson and these companies to be efforting to find devices or treatments or types of surgeries that can be used to help Linda and other women who have the types of problems that they had?
ADAM SLATER: There’s dangers there because if there’s a profit motive, it’s not going to be pure.
DR. EMILY SENAY [narration]: LAST SUMMER, ETHICON PULLED THE MESH KIT OFF THE MARKET – SIX YEARS AFTER LINDA HAD HER FIRST OPERATION. DURING THAT TIME, LINDA AND JEFF SAY THEY’VE SPENT THEIR ENTIRE RETIREMENT SAVINGS ON MEDICAL TREATMENT. THEY SAY THEY CAN NO LONGER BE INTIMATE. AND LINDA HAD TO GIVE UP HER JOB. SHE TAKES NARCOTICS TO CONTROL HER PAIN AND SPENDS MUCH OF HER DAY AT HOME.
DR. EMILY SENAY: Do you blame one person? Who do you blame?
JEFF GROSS: Oh, I– I blame the manufacturer, definitely. Because if it wasn’t for the manufacturer, this product would not be out there. You know, I– I do believe the FDA has a role in it. They– they definitely have a role, and they need to be more aggressive on making sure these products are safe.
LINDA GROSS: I want to help other women to not go through what I’ve gone through. Just– it saddens me because they– they– they took– they took innocent women and used us as guinea pigs is how I feel.
JEFF GREENFIELD: Numbers aren’t available for exactly how many women have had mesh implants like Linda’s but lawsuits against the implant manufacturers continue to climb each day. For more on the regulation of our medical devices both here and abroad, I’m joined now by Dr. Josh Rising. Dr. 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. Dr. Rising, thank you for joining us.
DR. JOSH RISING: It’s a really important issue, so it’s great to see the attention that you’ve been able to bring to it.
JEFF GREENFIELD: And I should mention to our audience, this is not just a clinical issue with you. You’ve also been a patient, a diabetic since you were 9 years old. So how has that affected how you look at the whole issue of the safety of medical devices?
DR. JOSH RISING: Ever since I was diagnosed with diabetes when I was 9 I’ve been encountering medical devices on a daily basis. I currently have an insulin pump to manage my sugar. So I certainly see the potential that medical devices have to really produce some significant improvements in quality of life and overall healthcare outcomes for patients around the country but we also see the cases with the mesh that we’re talking about, we have a systemic problem in that it can take us much too long to identify problems with devices once they’re on the market place.
JEFF GREENFIELD: You may have anticipated my next question as I was just looking now for a kind of a view from 30,000 feet…now as a general proposition how well is our system to regulate these devices working?
DR. JOSH RISING: Well you know I think we’ve seen a number of problems over the past few years with some devices not having..we haven’t recognized that the devices have some significant safety problems until well after we should. These are problems including the mesh that we’ve heard about, problems with some implantable defibrillators, for individuals with some cardiac disease, and some metal on metal hip replacements and so these problems have really shown that it’s taking us much too long to identify devices that have problems and take appropriate action to get them off the marketplace.
JEFF GREENFIELD: Now I mentioned that you’re interested in regulation here and abroad. When you look abroad and look at other countries, how are they doing on the whole issue of regulation, medical safety, the safety of these medical devices, how do we stack up against some other first world countries?
DR. JOSH RISING: I think there’s one other very relevant example from Australia that I think would be illustrative to show the kind of potential of what can be done if you have a system that really tracks the medical devices. So in Australia they have what’s called a registry which tracks everybody in their country who’s gotten a hip or knee replacement. And this has been going on for about the past 10 or 12 years in Australia. And with this information, as they saw what happened with patients, they followed the patients over time, they discovered that patients who had metal on metal hip replacements, they discovered that patients had a much higher revision rate – meaning that the hip implants were having problems, and the surgeries need to be redone in these patients. And this was happening at a much higher rate than with patients who had other hip implants. So the registry communicated this information…and the docs in Australia stopped using these metal on metal hip replacements years before we stopped using them here in the United States. So it shows the potential that’s out there if we’re able to collect information on what’s happening in the real world with medical devices and what’s happening with medical devices and we can take appropriate action when we find if there are some devices that do have some problems.
JEFF GREENFIELD: So what’s stopping us?
DR. JOSH RISING: We’ve got some important building blocks that are just coming into place that we haven’t had before. One of the most crucial of these is something called a unique ID. One of the problems with tracking medical devices through the healthcare system is that there one of virtually the only consumer products that doesn’t have a unique number which makes an easy way to track. This would be something like a bar code…like you know when you buy a deodorant at the pharmacy, this is a way to know, you know this is the product that I have. So without a unique identifier, a unique ID it’s very difficult to assess what’s happening with the performance of devices. So Congress has recognized the importance of having a unique id for medical devices and they’ve required the FDA to implement such a system so that we can tell which hip does somebody have or which stent is being placed in. So the FDA, very soon we hope is going to come out with their final rule which will instruct manufacturers how to implement this system across their devices. And then once this is in place this is really going to be the building block for a lot of more advanced forms of surveillance, of figuring out what’s going on with devices.
JEFF GREENFIELD: We’ve heard from some companies that you put on more regulation, what you’re going to do is you’re going to increase cost, you’re going to slow innovation. Is that relevant to what you’ve been talking about in terms of what you want to see done? Is that a legitimate concern?
DR. JOSH RISING: You know certainly we think of a better system of post market surveillance of figuring out what’s happening in the real world as being a win for both safety and innovation.
You know there’s some people who talk about safety and innovation as being diametrically opposed that if you improve safety, you’re going to hurt innovation or vice versa. But we see post market surveillance as a way where you can really achieve the best of both worlds. And that’s if we’re able to collect real time information on what’s happening with medical devices we can improve safety because we can identify devices that might be problematic and then remove them from the market place, but it’s also going to help innovation because this is also going to give manufacturers much more information about what’s happening with their devices than they have now, and they’re going to be able to use that information in the next generation of their devices, so we really see this need to collect more information on these devices as being both a win in the safety and innovation columns.
JEFF GREENFIELD: We’ve just got a few seconds left, but if there’s one piece of advice you would give to a patient about to undergo such a procedure, what would it be?
DR. JOSH RISING: You know I think as a doctor myself my recommendation is to speak with the person who’s performing the procedure, talk about the risks and benefits, assess how much evidence has been collected on the device and really make sure that clinician has participated in some follow-up studies on the device because that’s what’s going to get us the information that’s really going to tell us if this device is working as expected over time.
JEFF GREENFIELD: Alright. Dr. Josh Rising, thank you so much for joining us and giving us some insight into what is obviously a significant medical issue. Thanks a lot.
DR. JOSH RISING: My pleasure. Thank you.
JEFF GREENFIELD [narration]: THIS WEEK ONLINE… TAKE PART IN OUR WEEKLY POLL…THE TOPIC: FDA REGULATION. ALSO, MEET NINE WHISTLEBLOWERS WHO CALLED THE FDA “FUNDAMENTALLY BROKEN.” VISIT PBS.ORG/NEED TO KNOW.
JEFF GREENFIELD: That’s it for this edition of Need to Know. Next week I’ll be back with a roundtable that tries to find common ground among economic thinkers left, right, and center.
BERNSTEIN: We talk about taxes as if taxes are a pure cost and have nothing to do with what we use them for.
MAKIN: The question is, when you try to solve the problem, you louse up the way the economy works.
FOROOHAR: Income inequality is actually the major economic problem of our era. And I think that it’s a major contributor to slow growth.
JEFF GREENFIELD: I’m Jeff Greenfield. Thanks for watching.