It Takes a Team: A Unique Perspective About Medical Device Safety

 

Ah, the human knee: the strongest joint and one of the most vulnerable. Ask anyone with knee pain and they’ll attest to that.

I had bad knees for most of my life. In high school I ran cross country and had my first knee surgery at age 17. In the decades that followed I had several arthroscopic surgeries on each knee with the well healed scars to show for it.

In 2017, I was prescribed propranolol off-label for PTSD. Its intended use is to lower blood pressure. My doctor assured me that there have been promising results in PTSD studies. It lowered my blood pressure, alright. To the point that I fainted and lost consciousness. In the fall, I broke my right ankle and injured my left knee. I had surgery on my ankle and then I went back to address my knee.

I was 47 at the time of the last injury and I was told by one of the surgeons at OrthoCarolina that I was bone on bone but too young for a knee replacement. Ideally, a patient should be 50+. I felt really discouraged at the thought of waiting years for relief and I resigned myself to just being in pain all the time.

I get it though: artificial joints have a limited shelf life. The older you are, the less likely the new joint will need revision or replacement. Knee replacement surgery is a BIG surgery and other options should be exhausted before considering such an invasive surgery.

Recently a friend of mine, who happens to also be a Mecklenburg County Commissioner here in Charlotte, NC posted about her recent knee replacement surgery and spoke highly of her surgeon. I turned 51 in 2021 and I wanted to revisit my intervention options. My friend recommended Dr. Benjamin Wooster at OrthoCarolina.

He did a thorough exam of my knee and reviewed notes from past surgeries and saw that I had tried the conservative treatments first. It was his medical opinion that I was now a candidate for total knee replacement.

When he asked me what I do, I explained that I am a Special Government Employee (SGE) at the U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH). In my role, I review adverse event reports for medical devices and make recommendations to FDA and device manufacturers about labeling, clinical trials, and post market surveillance.

I am also a 16-year patient advocate. This came about in 2006, when I was inappropriately prescribed Levaquin for a suspected sinus infection. I have suffered over 30 tendon ruptures as of this writing. I call it “accidental advocacy” and I’ve learned a lot since I had to navigate a complicated medical system and do my own research about the FDA approval process for medications and medical devices. I learned that in order to have informed consent that I need to work with my doctors and ask questions to help me weigh risk versus benefit.

When Dr. Wooster asked me if I had any questions, I told him I had many and explained why I was asking.

One of my main questions was about what device he uses most often and why. He told me that for my procedure, he would use the Stryker Triathlon for a total knee replacement. Having the name of the device and who makes it allows me to do my own research about the device, whether there have been any recalls or if a Black Box warning exists. When I asked him if he would be open to discussion if I found a device that I thought was safer, he told me he was open to that discussion.

I also wanted to know what the device is made of. Something we don’t often think about are what the components are made of. Typically, medical devices are made of metal and plastic. Most often out of titanium. What the average consumer doesn’t know- and that I learned in my advocacy and my work at FDA- is that coatings can be made of something different and patients are not often informed about what the other materials are made of. I asked this question because if I had a metal allergy, I could develop issues down the road. If you have a metal allergy, always let your surgeon know.

I have many allergies (NSAIDS, aspirin, sulfa, wound dressing adhesive, latex… to name a few). Luckily, I have no known allergies to metal.

Another question I had was whether he was “married” to a particular device. He understood that what I was really asking is whether he receives any consulting money from device companies. This was something I never would have thought of, had I not been involved in patient safety. If medical device sales reps have a particularly strong relationship with the surgeon, there could be the appearance of the surgeon having a direct financial incentive to use the device. Sometimes the surgeon has been flown someplace sunny to “learn about the device” on the manufacturer’s dime. My opinion on that: These relationships could unintentionally cloud the surgeon’s judgment, meaning you are not necessarily getting a fully objective view about what device is best for you. It is public information how much a doctor receives from the pharmaceutical industry and it is your right as a patient to know what those relationships are. It is one piece of a clear picture so you can decide what is best for you. After my visit with Dr. Wooster, I looked up how much he has received and confirmed that he was honest with me that he had no financial conflict of interest.  This reassured me that whatever device he and I landed on, that it was in my best interest and not financially motivated. This also reassured me that I had a doctor who was honest with me and that builds trust.

Dr. Wooster answered all of my questions to my satisfaction and as a team, we landed on the Stryker Triathlon for my joint replacement. I had it done on December 14, 2021.

I’m five weeks out now. I won’t lie: the recovery from total knee replacement is not an easy one. Knowing what recovery could look like is also something I consider when weighing my options.

As a patient who has been harmed by the pharmaceutical industry and as an employee of the FDA CDRH, I feel it gives me a unique perspective on how patients and their doctors can work together to make sure informed consent is achieved. Ask questions. Do research. Work with your medical team so you get the best possible care.

Does my position at FDA make me worried about my implanted medical devices? Absolutely. I’ve seen what can happen if a device fails or causes adverse events for the patient. Which brings me to my next point: Just because something is FDA approved, doesn’t make it safe. Here’s some information I have on my website about the approval process of medical devices that you may find helpful. (As a side note, I also have plates and screws in my C-spine that was implanted in 2008. It is monitored every year with an xray and I am happy to report I have never had any problems with it).

If you do have an adverse reaction to a medical device, it’s important to contact your surgeon but also to report that to the FDA. We look at reporting systems and data to decide if more post market surveillance is necessary or if there needs to be a change in labeling. I’ve also sat on FDA panels where a device is recommended for recall and unfortunately, the patient is the last to know.

An emerging technology is Unique Device Identifiers (UDI). UDI’s are a unique bar code specific to materials used in your surgery. Several companies are developing ways to track the UDI’s so that if a recall is issued, a patient can be notified of that. Though adverse event reporting is voluntary, I’ve made recommendations to make it mandatory and to make it easier for anyone to report an adverse event.

Patient safety is up to all of us and it can be complicated. I find that communication is key from every perspective: the patient, their medical team, and the FDA.

It is never an easy decision to have a medical device implanted but I will say this: I had enough information from various perspectives to feel comfortable in my decision to go ahead and have an artificial joint implanted.

FDA Needs Teeth: How non-compliance is dangerous for patients

FDA Needs Teeth

Historically, the FDA has often been perceived as a powerful US agency that protects the public. What most members of the public do not know is that the FDA has no enforcement powers when a manufacturer has violated a rule in a federally regulated activity.

 

My work with the FDA

I have worked for the United States Food and Drug Administration (FDA) as a Special Government Employee (SGE) and consumer representative since 2016.  I also have personal, first-hand experiences as a harmed patient, so I understand the frustrations of other harmed patients who need the FDA to listen and make necessary changes to improve patient safety.

To be fair, in my time at FDA, the agency has made changes that improve patient safety, yet it continues to lack measures to hold pharmaceutical companies and medical device makers accountable for FDA approved products that are proven unsafe.

 

How the panels work

FDA Center for Devices and Radiological Health (CDRH) advisory panels review and analyze data from both the FDA and the pharmaceutical industry, and are given briefings prior to panel hearings.  On the day of the hearings:

  • Both FDA and industry representatives give presentations and listen to the testimony of both harmed patients and those who have benefited from the products.
  • Panel members consider this information and decide whether the risks outweigh the benefits.
  • Panel members deliberate and make recommendations to the FDA.

 

What happens when there are violations?

If there have been violations of the Food, Drug, and Cosmetics Act, aka The Act* , the FDA sends warning letters to manufacturers that have violated rules in federally regulated activities.

While the letters communicate the agency’s position on a matter, they do not commit the FDA to an enforcement action.  The FDA does not consider a warning letter a final action on which a company can be sued.  Companies are given the opportunity to voluntarily take corrective action, but have little incentive to comply.

 

Testimony from a survivor

I’ve sat on many advisory panels, but one of the most notable panel hearings that illustrates the need for accountability was on March 25 and 26, 2019. The advisory panel met to discuss Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA-ALCL) . BIA-ALCL is a specific cancer caused by breast implants; it is different from breast cancer.

One particular testimony from survivor Roxanne Vermeland–one of over 80 speakers urging FDA to take action–stuck with me.  She is a survivor of both breast cancer and BIA-ALCL.

After surviving breast cancer and needing breast construction, she then developed BIA-ALCL from the implants. Last year, her BIA-ALCL advanced to stage 4 when it spread to her lungs. Thankfully, chemotherapy put her in remission.

While the FDA agrees that breast implants have more risks than benefits, their actions on the matter have been limited.  For example, device makers Mentor , Sientra , Allergan, and Ideal** have not complied with warning letters.

 

Limited actions – Too little, too late

Allergan issued a worldwide recall*** on macro-textured implants after the advisory panel met, but before the FDA issued a warning letter.  The warning letter was issued after the device recall because the FDA wanted recalls of ALL breast implants Allergan made, and because Allergan failed to complete long term studies as required.  Allergan still hasn’t completed the studies.

Ten months after the recalls, Allergan attempted to track down the women who still have their implants.  Many of the survivors said they found out about the recall through social media or news reports, not from the FDA.  By their own admission, FDA states that warning letters are not the final action, which brings up an obvious question:  Why isn’t there a final action?

 

The need for accountability

When companies fail to respond to warning letters, there are effectively no consequences from the FDA, resulting in continuing dangers to patients and consumers.

To be effective, the FDA needs to be more clear about messaging, follow up with manufacturers that do not comply, and have swift, strict consequences for non-compliance.  These consequences might include substantial fines for manufacturers that do not comply with regulations.

Under the current model, companies pay no fines, and  the FDA gets 50% of its funding from drug companies that pay to fast-track their products.  Fast tracking means the FDA will approve a product with little or no testing for safety and effectiveness.  This obvious conflict of interest comes at a cost to patient safety.

 

Summary

Without a strict accountability model, including consequences for companies that fail to comply with regulations, the FDA risks becoming irrelevant and ineffective, and failing in its role to protect patients and  consumers.

Notes

* The FDA was granted authority by the laws of The Act. Chapter III of The Act is called Prohibited Acts and Penalties. This section contains both civil law and criminal law clauses. Most violations under the act are civil, though repeated, intentional, and fraudulent violations are covered as criminal law. One notable 1943 Supreme Court case called United States v. Dotterweich, in which The Act uses strict liability.

** Mentor (3/19/19): https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/mentor-worldwide-llc-acclarent-573520-03182019

Sientra (3/19/19): https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/sientra-inc-573436-03182019

Allergan (5/28/20): https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/allergan-607690-05142020

Ideal (5/28/20): https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/ideal-implant-incorporated-606103-05142020

*** In 2019, Allergan issued a worldwide recall of one specific breast implant called Naturelle textured implants around the time of the March 25 and 26, 2019 hearing. The FDA sent the warning letter a year later because FDA thinks all breast implants cause the manmade cancer and that there should be a recall on other breast implants Allergan makes, not just the one.  Allergan, per their premarket approval application, was required to do a 10 year post approval study to follow up with patients who got sick from implants.  Allergan failed to do so.  The warning letter tells Allergan that they failed to uphold the conditions of their device approval.  They never did the 10 year study, a significant violation.

 

Rest in peace Ed Hollingsworth

The world’s light dimmed today on those of us who were gifted to have known him. I heard of the passing of my friend Ed Hollingsworth this morning.

People come into your life for a reason. You know that person who just stands out for all the right reasons? That was Ed.

The first time I met him was at a Consumer Reports conference in Washington, DC. It was the first time I dipped my toe into the patient safety waters. New to this and quite honestly a little intimidated being surrounded by the best patient advocates across the country, I kind of wondered how I got to be around such stellar talent.

People were gathered in small groups when I walked in and I tried to find the table with the least amount of people to carve out a little space. They all knew each other, almost like a family reunion. I didn’t know anyone and even though it’s hard to tell when the Jersey in me comes out- or when I go off on a rant- I’m actually quite shy at first. Painfully so.

I sat at that table feeling out of place. I don’t know if my awkwardness was obvious but over comes a big, smiling guy. This sounds so cliché but his smile really did light up a room. He introduced himself as Ed and sat down next to me.

The above photo is Daniela, me, and Ed.

It was small talk at first. He maintained eye contact but I noticed he occasionally looked off to the middle of the room, and smiling even bigger.

“See her?”, pointing at his wife Marian, who was close by and talking with other people.

“That’s my wife. She is so amazing.”

She is exactly that.

I remember his smile so well. It was a smile that spoke so much but in no words. There was a sparkle there. I couldn’t help but chuckle a little bit because it was a blend of school boy crush and a love you only see in movies and wish to aspire to.  Best friends. Two people in one soul. It sounds weird to say of a couple you just met. There was something so genuine and precious there.

I don’t really remember how we got on the subject of chocolate. It was probably some piece of bagged mini candy bars on the table but he said “You want to see chocolate? My wife makes THE BEST”. I scrolled through his phone looking at boutique-level gorgeous chocolate covered Easter Eggs and Reece’s dipped in chocolate and toffee. He made a little quip about how he shouldn’t be eating it (patting his stomach) but said he just couldn’t help it.

His wife Marian finished her conversations and sat next to Ed. I noticed he held her hand on the table. That memory sticks with me when I think of Ed.

Before the conference officially started, he leaned toward me and said “We’re all family here. You included”, and then the conference speaker started speaking.

I remember at some point the conference ended for the day. We were in a hotel lobby waiting on delivery food.

Ed was sitting down and I had arrived a little late. He stood up and offered the only seat available at the table. As people were getting annoyed by the late food delivery, the seat next to me opened up. Across from me was Robyn, a survivor of patient harm. I remember Robyn started singing. It was beautiful and soulful, just like her, and Ed started singing along with her and he had the biggest smile. Their voices intricately woven and blended when they sang.

That’s when I found out about his and Marian’s love of theatre. In high school I remember the plays the drama department did. I got to watch a lot of them back stage as prop department person number 3. I mentioned a couple songs I remembered from them and he knew them all by heart. He was an actor. As he showed me photos of performances, he hummed some of the tunes.

As an aside, we did get the food we ordered but it’s the people and the music that sticks out.

When the conference ended, we all hugged and went our separate ways. Ed was right. We became family. It’s been a while since we all got together but you wouldn’t really know it because the bonds are strong.

I got to know Ed and Marian a lot better through our work in patient safety and on social media. They are the foundation on which I continued my work in patient safety. You see this woman here before you? A much different- and better- person because of their work and their friendship.

Ed posted all the time about his walks with Marian in their neighborhood. I can still see the vivid sunset pictures. One photo that I remember clearly is an un-posed photo of her and a dog. He expressed how much he loves his wife and how she is his best friend.

Another conference came up not too long after the first one. This was in Yonkers, New York.

It is at this point I need to mention that during those years I had a wicked flying phobia.

My flight had been delayed because of a hurricane so I flew out the next morning. I posted a photo half in jest, half in needing moral support. It was of me. Terrified.

Because my flight was delayed, it was the day after I was supposed to leave. I calculated that I’d arrive at the airport in New York, catch the driver and be delivered to the steps of Consumer Reports riiiiight about when it started. I was right. It started minutes before I walked in. The introductions had just started.

 

As you can imagine with any phobia, I arrived at Consumer Reports pretty rattled. I was escorted by someone at the front desk. The room was packed. Except the seat next to Ed. In the middle of intros, he stood up and gave me a gigantic hug. It was the kind of hug where you felt safe. Home.

Marian stood up, smiled, and hugged me too.

During one of the breaks, I saw that Ed had his arm around Marian. I don’t know why but I felt so compelled to take a photo.

 

I’m glad I did. This would be the last one I ever take of him, at dinner.

In my mind, I still remember how he playfully “made fun of me” for being THAT person taking photos like a tourist. I smile at that. I am that person.

I knew he was sick recently. Not a lot of people did. I don’t think I knew the full extent of how fast his cancer was. But I knew his posts were less frequent and with less spark than before. I knew why.

He last posted in early to mid-September. I went back and read them again this morning.

The announcement I dreaded, that Ed was extremely sick and Ed’s family asked friends and family to post for Ed, broke my heart into more pieces than I knew I had. Marian read Ed the messages. If there is any comfort at all in this, it’s that Ed knew he was loved by all.

Even over time zones and many miles between us, it was like the air got sucked out of the room when I read this news.

I hadn’t prepared for that kind of spark to go out.

Ed was the strongest, most genuine, friends-into-family kind of guy. He spoke his mind. But had a compassion unique to him. A smile that is only his.

I got word last night that Ed passed, surrounded by his family.

I had this all written in my head before I started typing. It was a lot more eloquent than this and I’m sobbing at the loss of my dear friend. I got to know Ed and his family. You won’t find anyone as dedicated to his family. They are his center.

Damn, Ed. You had a way with words and the right ones elude me right now. I look back in my Facebook albums and Ed and Marian are smiling in every one of them.

Thoughts and prayers seem so small as I’m writing this for a man who loved his life.

The sky has one more star named Ed.

Rest in peace, my friend.

Salesman caught lying to sell water system in Charlotte, NC: Hidden camera investigation

Hidden camera investigation: Action 9 catches salesman lying to sell water system in Northeast Charlotte.

http://www.wsoctv.com/news/9-investigates/hidden-camera-investigation-action-9-catches-salesman-lying-to-sell-water-system/642238505

It all started when I found this hanging on my mailbox.

Aquafeel Solutions said that our entire neighborhood’s water was contaminated and that they were offering free water tests to all homeowners in the neighborhood.

I was immediately suspicious and began doing some online research on the company.

It turns out that this scam was already reported in Tampa, Florida and Tega Cay, South Carolina.

Complaints about this company have been reported for years.

I then checked the Better Business Bureau website and it reports that the company had their accreditation revoked.

Aquafeel Solutions claimed they got permission from our HOA to test our water. I was suspicious of this also, so I contacted my HOA with this e-mail:

I contacted WSOC-TV Action 9 investigative reporter Jason Stoogenke and asked him if the station has heard of the scam here in Charlotte, NC. I’ve worked with Jason before about my work in patient safety and public health. I sent him the links I found about the scams in Florida and South Carolina.

At that point we didn’t know if there was any kind of fraudulent claims being made here in our area. Jason told me prior to the cameras being set up, “Maybe there’s something there. Maybe there isn’t. Let’s find out”.

WSOC-TV set up four hidden cameras in my house and set up other cameras to film.

 

Find out we did.

Jason and a cameraman were upstairs listening in and watching the hidden camera footage on a monitor.

In a period of 75 minutes, the sales rep made over 50 false claims.

Too many to post but here are a few:

  • Claim: Our water is supplied by Lake Catawba. This is false. There is no Lake Catawba.
  • Claim: Charlotte water ranks worse than Flint, Michigan water. This is false.
  • Claim: Brita filters only removes lead. This is false.
  • Claim: White in your ice causes kidney stones. This is false.
  • Claim: Heroin is found in Charlotte water. This is false.
  • Claim: Aquafeel is a division of NASA and their filtration system is used by astronauts. This is false.
  • Claim: Your skin can absorb all the toxins in your drinking and bathing water in 30 seconds. This is false.
  • Claim: You bathe in feces laden water every day. This is false.
  • Claim: McDonalds and Starbucks use their filtration system. This is false.
  • Claim: You won’t ever have to clean your toilets with this system because the water will be so purified. This is false.
  • Claim: You will see a guaranteed 29% off your gas bills if you install their system. That clean water heats faster. This is false.
  • Claim: The water is sent to your local water treatment center. That water is sent right back to you; you don’t have new water. This is false.

He even did a little magic trick in my kitchen. He had me fill two bowls with water. He added a chemical to one bowl, used a metal spoon to stir it, and the water turned orange. He said that the chemical he added tests for the chemicals Charlotte Water Utility uses to clean city water. Then he had me put my hand in the other bowl for 30 seconds, and then he added the same chemical. It stayed clear. He told me that my skin absorbed the contaminants and therefore the water stayed clear. I should mention that this is a science trick my dad taught me as a little girl. Ions mix with pH and alkaline causing the water to turn colors. My dad was a chemical engineer and I have a background in science. At no time did Aquafeel Solutions actually test for contaminants in my water. In fact, when I asked them to, the salesman said that we were “overthinking this” and refused to do any further testing.

The salesman said that military personnel and government employees get a discount on the $7,000 water filtration system. When I told him I work for the U.S. Department of Health and Human Services and I’ve done work with the FDA and CDC, he got visibly nervous.

In addition, the salesman again repeated that he got clearance from my HOA. This is the response I got when I emailed the HOA to ask them about it. They did not authorize any water tests and said they will be reporting this to the proper authorities.

 

When the salesman left, the reporter came back downstairs and kept shaking his head. He had a lot of claims to fact-check. Before he and his crew left, we took a group photo.

WSOC-TV fact-checked the claims which can be found here and here. They contacted Charlotte water, my HOA, a urologist, Delta faucets, UNC Charlotte, McDonalds, Starbucks, NASA, U.S. Department of Energy, the Internal Revenue Service, the U.S Department of Environmental Quality, and North Carolina Attorney General Josh Stein.

They also contacted Aquafeel and the salesman to get a statement from them.

WSOC-TV came back to my house on October 27, 2017 to do an on-camera interview with me.

  

  

The story aired on November 9, 2017. Jason Stoogenke came to my house again to film the intro live in front of my house, at my mailbox where this all started.

Bottom line: Always do independent research when a company tries to sell any product to you. While there are good companies out there, there are also fraudulent, predatory ones. By having all available information, you can make an informed decision about what is right for you and your home.