Not Tested on Humans

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It was 2006 and life for Melynda was very good. She was 32 years old. She and her devoted husband were raising two young sons.

Her friends liked to call her a Mormon Martha Stewart. The family was very involved in The Church of Latter Day Saints, also known as the LDS church. She taught sewing and bread making to fellow Mormon women and put on an annual fall pumpkin party for all the families in the church. Every year for Christmas, she’d make a big, elaborate gingerbread house.

Melynda had a master’s degree, and a fulfilling job. She felt strong and healthy; she even worked as a personal trainer on the side. 

But then, she started to feel a strange heaviness and pressure in her pelvis. She would feel it after a hard workout or a long day on her feet. She went to see a leading uro-gynecologists. He diagnosed her with Pelvic Organ Prolapse. It’s actually very common, especially for people who have given birth. About 50 percent of people with uteruses will have some degree of prolapse in their lifetime.

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Melynda’s case was mild though: it was stage one, and it wasn’t really impacting her quality of life. But the doctor recommended another surgical option — the “gold standard” of surgery for prolapse — pelvic mesh, manufactured by Johnson and Johnson. He presented it as a preventative procedure.

Meylnda trusted him. And so a few months later, she went in for the surgery. And as is standard, she first had to sign pages and pages of consent forms. 

When she woke up from the surgery, she experienced a sharp stabbing pain. During her six week recovery, members from the LDS church bought dinners three times a week and her husband Jeff was by her side anytime he wasn’t working. Weeks passed. She kept calling the doctor, telling him she was still in pain. But he kept telling her the same thing: it's not the mesh. 

After Melynda starts to uncover the truth about mesh, she starts to question her religion and her world view; she forms a new understanding of the true meaning of informed consent. 

This episode of Bodies calls into question what consent really means. How can you consent to something if you don’t have all the information?

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Transcript:

ALLISON: Before we begin, a heads up that this episode includes graphic medical images, some cursing and mention 
of sexual assault. 

This is Bodies, a show about people solving the mysteries of their Bodies. 

I’m Allison Behringer.

It was 2006 and life for Melynda was very good. She was 32 years old. She and her devoted husband were raising two young sons.

Her friends liked to call her a Mormon Martha Stewart. The family was very involved in The Church of Latter Day Saints — also known as the LDS church. She taught sewing and bread making to fellow Mormon women and put on an annual fall pumpkin party for all the families in the church. 

MELYNDA: Dinner time at my house was an event. I think food is my love language, I’m not sure but I — I found a lot of satisfaction in cooking and homemaking skills and things like that.

ALLISON: Every year for Christmas, she’d make a big, elaborate gingerbread house.

MELYNDA: One year, I created a replica of the home that we were living in. Like, you know — But out of gingerbread. And it was so much fun. And then on Christmas morning, we take hammers to them and we smash them all up.

ALLISON: Melynda had a master’s degree, and a fulfilling job. She felt strong and healthy — she even worked as a personal trainer on the side. 

But then, she started to feel a strange heaviness and pressure in her pelvis. She would feel it after a hard workout or a long day on her feet. 

MELYNDA: I don't want to call it a pain; it was just an ache. You know how like when you're on your feet too long? You're like,”Oh, my feet hurt.” It was that, but it was in my vagina. 

ALLISON: She went to see a leading uro-gynecologists. He diagnosed her with Pelvic Organ Prolapse. It’s actually very common, especially for people who have given birth. About 50 percent of people with uteruses will have some degree of prolapse in their lifetime.

Prolapse happens when pelvic muscles and ligaments weaken and organs like the uterus start to drop lower into the pelvis — in extreme cases, so low that the uterus starts to come out the vagina. In these cases, a doctor would traditionally do a surgery and stitch the muscles and tissue back together.

Melynda’s case was mild though — it was stage one — and it wasn’t really impacting her quality of life. But the doctor recommended another surgical option: vaginal mesh. He presented it as a preventative procedure.

MELYNDA: He said If you have this done now, it will prevent you from getting worse and worse and worse and worse in the future.  Let's put a stop to this now before your uterus is hanging outside of your vagina, because that's where you're headed.

ALLISON: He told her how the mesh is made from a woven plastic — similar to that goretex material that’s used to make rain jackets. He’d use a mesh called Gynecare Prolift made by Johnson & Johnson. The mesh looks a bit like a spider with six legs. If you can imagine the pelvic floor as a basket, the body of the mesh reinforces the pelvic floor and the legs extend through the pelvis and are threaded through ligaments. He would make cuts into her vaginal wall and slide the mesh into place. He told her it would be a quick six week recovery and the prolapse would be fixed for life. She did some research. She and talked it over with her husband Jeff. He trusted her to make the right decision. 

MELYDA: You know, I'm young and healthy. I don't smoke. I don't drink. Thumbs up. OK. I felt really confident. And I felt very hopeful. 

ALLISON: And so a few months later, she went in for the surgery. And as is standard, she first had to sign pages and pages of consent forms. 

MELYNDA: And I signed my name at the bottom, that I consented to this surgery, over and over and over again. 

When I first woke up, I cannot even begin to describe how much pain I was in.  

ALLISON: When she told the doctors about the sharp stabbing pain they told her it was normal post operative pain. During her six week recovery, members from the LDS church bought dinners three times a week and her husband Jeff was by her side anytime he wasn’t working.   

MELYNDA:  I didn't go up and down stairs. I didn't lift anything over three pounds. I didn't drive. I did all of the things my doctor had told me to do to make sure that I healed properly. Which is why it really surprised me that my pain levels continued. And even as the post operative pain got better. I had a continual burning.And pulling. I mean, just all throughout my pelvis, like it was on fire, everywhere on fire. 

ALLISON: Weeks passed. She kept calling the doctor, telling him she was still in pain. But he kept telling her the same thing: 

MELYNDA: It's not the mesh. It's not the mesh. It's not the mesh. It's... I don't know what it is, but it's not that. It's not that. It's not that. It can't be that. And so he's saying this is normal. It's going to get better. So here's the strong, authoritative male figure telling me. Your experience is wrong. 

ALLISON: Then months passed. And after hearing the same response over and over again, she believed him. She stopped calling.

MELYNDA: So I'm going to suck it up and I'm going to carry on

ALLISON: It was like the Mormon hymn that she had been taught as a child. That no matter what happens, you carry on.

Soon, Jeff got deployed — he was in the Army Special Forces. And Melynda started working on a PhD. But the pain was getting worse. It was so bad that she’d have to lay down in the back of the classroom. 

Melynda developed more symptoms. She had a constant greenish milky discharge. When she went to the doctor, they told her it was a yeast infection. The pain intensified. It felt like a knife was pressing into her vaginal wall. 

When she inserted a finger inside herself, she could feel something, a roughness inside her vagina. But her doctors would say, oh, that’s just scar tissue from the mesh implant surgery, or that’s just inflamed skin. Then she started developing autoimmune symptoms. 

MELYNDA: I felt like I was eighty five. I felt like literally like my body was dying, My joints hurt horribly, my joints. Oh, they hurt so bad 

ALLISON: An endocrinologist ran every test in the book. And the doctor told Melynda: I’m sorry, we don’t know what is going on with you. 

Sex was painful. But since Jeff was only home a few weeks at a time, she felt like it was something she could endure and she didn’t tell him how badly it hurt.

And then Melynda found out she was pregnant. If Melynda had experienced pain before, it was nothing compared to the pain she experienced during pregnancy. 

MELYNDA: So the pain was just I you know, on a scale of one to ten, it doesn’t... It doesn't even compute there. I was throwing up all the time.

ALLISON: As the baby grew, her pelvic muscles were stretching; the mesh was not.

Melynda gave birth by c-section. The pregnancy and birth took the last reserves of energy from her.

At this point, Melynda had been in excruciating pain for 7 years. 

As Melynda tells me her story, there’s a small part of me that just doesn’t understand how through all of those years, she didn’t suspect it was the mesh.

MELYNDA: You know, I know it sounds really dumb, but, you know, I never...I never connected it with the mesh for years. Never. 

ALLISON: But when you understand the way Melynda was brought up — how she raised never to question authority, how she was conditioned to believe that she was the problem — it’s really not that dumb at all. It actually makes a lot of sense.

She grew up in Utah in a big Morman family where everyone in the community was part of the LDS church. 

Her life in the LDS church was comfortable, predictable and safe. As long as you followed the rules: Church every Sunday. No TV, no playing cards, no skirts above the knee .

MELYNDA: The only way you could be happy is if you were, you know, living exactly how you were told you were supposed to be living because that was the only path to happiness.

ALLISON: But the LDS church did not support Melynda in her times of need.

When she was 17, a man in the LDS community raped her. She didn’t know the word for what had happened, but she knew that it was wrong. 

So she went to her LDS bishop, he man in charge of the congregation, the man who she was supposed to turn to when she needed help. 

That evening at the church, the hallways were dark as she made her way to the bishop’s office office. He was sitting behind a large desk. She sat down, summoned every bit of courage that she had and told him what the man had done to her. He drew his eyebrows together and...

MELYNDA: His face got very, very stern and his voice got hard. He told me that there's no way that this man could have done this because he'd known him his whole life. And there's no way that he would have done this unprovoked. And that if, if...if anything had happened, it was because I had made it happen myself. 

ALLISON: Melynda started to cry. She knew the LDS teachings: sex outside of marriage was a terrible sin, second only to murder. 

Before she left the bishop’s office, he handed her a book, The Miracle of Forgiveness, written by a leading member of the church.

That night, she lay in bed, diligently flipping through the thin pages, hoping she would find a way to forgiveness. But in the chapter on sexual sin she read a different message. It said, “It is better to die in defending one's virtue...than to live ...having lost it without a struggle.”

MELYNDA: I can remember holding it in my hands, and seeing the words and staring at them going. Would it have been better if I had died? Should I have died? And recognizing at some very cellular, deep spiritual level that those words were wrong, but if the words were wrong and the person who wrote them was wrong, then that would mean I'd have to reject all of this about my upbringing and my religion. Or if I'm wrong, then all of these other things that I know are still safe. They're still good. And it was easier to believe that I was wrong than everything that I have been taught my entire life up to that point was wrong. OK, It's me. It's my fault. It must be my fault. 

ALLISON: Melynda was upset and confused. But anger was not an emotion a good Morman girl was supposed to feel.. 

MELYNDA: If there was any anger. It was self directed back towards me because I was the one to blame for it. 

ALLISON: Melynda wanted to be a good Mormon. But she felt like a damaged person. If she was already a sinner, did her actions even matter anymore

With only a few months left of her senior year, she dropped out of high school. She started dating someone and moved in with him. And then, she got pregnant.

In the LDS Church, there are two options for unmarried women who become pregnant: either you marry the father or you place the baby for adoption. 

She’d seen a violent streak in the father and knew she couldn’t marry him. She wanted a good life for her baby.  

She called her mom and came home. Melynda knew the consequences. She was disfellowshipped — a kind of probation where Melynda couldn’t speak during church meetings or take part in any religious sacraments. 

When she would go to church services, she sat in the back in the overflow section. 

MELYNDA: Everybody knows I'm pregnant. So you're getting all of those side eye glances. The you know, the you whispering as you walk by and things like that. But I was so committed to being repentant and doing the right thing.

ALLISON: Her bishop had made it clear to Melynda that she could only return to full fellowship if she agreed to give up her baby for adoption. It was her only path to redemption. But she didn’t want to give up her baby. Because when Melynda gave birth, she fell in love.

MELYNDA: So my daughter was the happiest, sweetest, most roly poly, delightful, charming little girl ever ever. We would go places out in public and people would just fall all over themselves because she was beautiful. She was so happy. We — we were happy. 

ALLISON: But as the months passed, the church ramped up its pressure. They reminded her of a central teaching: a child can only join her parents in heaven if her parents are married. It would be selfish to raise the child as a single mom.

MELYNDA: That...that there were times where, you know, I would lay in bed and I would be nursing her or rocking her sleep, and the absolute bliss that I would feel...but then on the other hand, feeling so guilty. Because I wasn't married 

ALLISON: One day during a required counseling session, the counselor gave her a worksheet. It had two columns on it. On the right was a list of all the things that an adoptive family could provide — like  a college education and a two-parent household. One the left, there was a list of what a single mother could provide. It was blank except for “love.” They asked if there was anything else she could put into her column.

MELYNDA: I already felt undeserving, unable, incapable. And then to have a counselor who said to me, is love really enough? And I remember that very clearly because. I questioned, is it really enough? Is...is love really enough? 

ALLISON: Eventually, Melynda gave into the pressure. She decided to give her baby up for adoption. Her daughter was 9 months old.  She was still nursing.

Melynda doesn’t remember much about the day she signed the adoption papers. It’s still too painful for her to talk about.

MELYNDA: I have very few regrets in my life, but this is one of them — in fact i think this is the only one the only thing in my whole entire life. 

ALLISON: The church welcomed her back. 

We’ll be right back.

In the years that followed the adoption, Melynda carried on. And she pushed away the sadness and guilt. She placed her trust in the LDS church and she did everything she could to transform herself into an ideal woman — that Mormon Martha Stewart. She got her education. She married Jeff, had 2 more kids. She filled her life with action to detach herself from her past.

MELYNDA: All of this was being driven by this need to prove, I think, to myself and to my culture that I was worthy and that I was good enough and deserving to raise my children. 

ALLISON: And as long as she was busy producing and achieving, she could avoid the anger and the questioning. Because in the LDS church, anger and questioning are dangerous.

But the years of physical pain after the mesh surgery changed all that. It forced her to be still. She couldn’t push through anymore. And in those hours, lying in bed, immobilized by pain, she spent a lot of time thinking about the decision she made when 19: 

MELYNDA: I could never get past the fact that on April 4th in that judge's office, I had sat down and I had signed by name to that voluntary termination of parental rights paperwork. And I carried such self-loathing and anger at myself for being so foolish as to signing that. I'm the one who consented to that. I'm the one who signed that paperwork. I'm the one who agreed to let this happen.  

ALLISON: In other words, she had done this to herself. And she felt like every bad thing in her life — it was all of her own making. She expected to suffer.  

Then one day in 2013, 7 years after she got the mesh put her in body, Melynda got a call from a friend

MELYNDA: And she said, Hey, Melynda, have you seen an... seen any of those commercials on TV about, you know, the mesh litigation? 

ALLISON: No, she said. Melynda hadn’t seen the commercials. 

MELYNDA: But I went online and I found that there were thousands and thousands and thousands and thousands of women around the globe that had experienced this exact same thing that I was going through. A river of anger and rage in me was unleashed.

I couldn't deal with this anger by making myself busy, by achieving things, by building scale replicas of the homes we're living in and out of Gingerbread — you know.  I took that anger and I focused it on the research, you know, because at that...by this point, you know, I had a phD. I know how to research shit. 

Melynda discovered that the Johnson and Johnson Gynecare mesh had been brought to market without being tested on humans. 

And it wasn’t just mesh. The majority of the tens of thousands of implanted devices that are on the market today — like hip implants, breast implants, and dental implants — were never safety-tested in clinical trials on humans. 

DIANA ZUCKERMAN: It does seem crazy. You know, you need a little history here. Originally, the FDA’s mandate was to look at the safety of food and drugs.

ALLISON: That’s Dr. Diana Zuckerman, president of the National Center for Health Research. It wasn’t until the 1970s after an IUD device injured thousands of women that Congress finally started drafting a law that would require the FDA to regulate medical devices the same way it regulated drugs: to make sure they were safe by running human trials.

DIANA ZUCKERMAN: But by then, there were already thousands of medical devices on the market and the medical device industry was pretty good at lobbying. 

ALLISON: And the companies that made them were like, what are we supposed to do? Take all of these devices all off the market and test them? At this time, doctors were already using mesh for surgeries like hernia repair

And so in 1976 when Congress passed the law requiring clinical trials in medical devices, they first grandfathered in any device currently on the market. AND they added a section to the law that said that you can put a new device on the market without testing it on humans AS LONG AS it’s similar enough to something else that already exists.

Overtime, partially under pressure from device companies, the FDA kept loosening it’s definition of “similar enough.”

DIANA ZUCKERMAN: Over the years, more and more devices were allowed to be sold that weren't even that similar. They would be a product made out of a different kind of material used in a different part of the body, perhaps a different shape, a different size. And yet they were still being allowed on the market. 

ALLISON: The first transvaginal mesh was created in 1996. And since it was “similar enough” to mesh used for other parts of the body, the FDA cleared it. But it was recalled only a few years later because of thousands of injuries. The most common complication was erosion — which is when the mesh pushes through tissue or into organs.

And yet, device manufacturers like Boston Scientific and Johnson and Johnson and kept putting new transvaginal meshes on the market. And the FDA kept clearing them because they were similar enough to this first transvaginal mesh. It didn’t matter that it had been recalled.

In 2005, J&J started selling a new version of transvaginal mesh: Gynecare Prolift for pelvic organ prolapse — the mesh that the doctor implanted in Melynda. Again, the FDA cleared it without requiring human trials from J&J. It was similar enough.

Melynda was reading about thousands of women who had been injured or even killed by Gynecare mesh. So why wasn't the FDA doing anything about it? 

The FDA keeps track of device injuries and deaths in a database, which is accessible to the public. If you’re a patient or a doctor and there’s any injury from a device, you can submit it directly into the database yourself. 

If you’re a manufacturer and receive a complaint from a doctor or patient, you are required to submit a report to the FDA. 

But there are some MAJOR flaws in this database. For starters, it’s clunky and nearly impossible to search. even the FDA doesn't know everything that's in there. Which is why  someone named Madris Tomes built her own system, which pulls in data from the FDA website and makes it user-friendly and truly searchable.

So let’s say you're a doctor and you’re trying to figure out how common erosion is with pelvic prolapse mesh. If you go onto the FDA website, you’ll find that only about 2,000 cases of erosion. But if you use Madris’ system with the more advanced search capabilities you see the true number, which is about 17,000 cases of erosion — WHICH IS A BIG DIFFERENCE

But even Madris’ numbers are not the full picture. There is another flaw in the database.

Just last year, in 2019, journalists reported that there was another database that was hidden from the public. What was happening was that manufacturers were allowed to submit reports that bypassed the public database.

MADRIS TOMES: So even concerned physicians weren't getting the data they needed to make choices for their patients. So it wasn't just about patients not knowing. It was about physicians and the medical community not knowing about the true number of risks with the devices. In the months that followed, under pressure, the FDA released 5 million previously hidden reports to the public for the first time.  

Madris ran the numbers. Suddenly, the reports for some of the riskiest implanted devices doubled or tripled. Like for example, when she looked at breast implant, reports of complications rose from to nearly half a million — 5 times that amount that was available before the FDA released the data. 

Madris thought that she — and the public — finally had all the injury reports! 

BUT THEN, a few months later, she got a call from a patient harmed by mesh

MADRIS TOMES: And said, oh, how many ever came out in that big data dump? And I looked it up and went, Oh, my gosh. They've never released those. 

ALLISON: The FDA did not release the data for mesh. As of this recording, the FDA STILL hasn't released them.

When we reached out to the FDA, a spokesperson told us in an email that the FDA never received these reports in question — the alternative summary reports about mesh from manufacturers. However, based on our reporting we found evidence that they did — I can see manufacturer summary reports for Gynecare mesh — and I can see that the data from these reports has been redacted. This information we need to have the full picture on mesh...it’s missing.

Throughout all of this, there were some groups of people who knew the mesh could be potentially harmful — mesh manufacturers like Johnson and Johnson.

One day, Melynda was sitting at her computer following court cases where mesh users were suing J&J and she came across documents from one of the trials. It was internal emails between J&J’s marketing department and a team of outside scientists who were doing independent research on mesh risks. The scientists wrote to J&J that painful sex was a common side effect and any patient who was sexually active should be be warned of the risk before getting mesh implanted. This email went up the chain of command at J&J and they essentially ended up saying, if we put this warning label on, no one is going to buy this. 

The labels had already gone to print without the warning,

MELYNDA: So they didn't change it. I had reread them and been like, how is this? Wait a bit, how is this possible? I mean, if I had known that the number one contraindication for use was sexual activity, do you think it ever would in a million years would have been like, well, yes, sign me up for that one. 

I picked up my keyboard and I just whacked it really hard on my desk. I mean, like across a corner of my desk and it like the back...I hit it so hard, the back cracked. And like some of the keys popped out because I was like, these people destroyed my sex life. And they're completely fine with it. We’re completely fine with doing this. And it wasn't just me…. It’s thousands and thousands of other women. 

ALLISON: When we reached Johnson and Johnso for a comment, they wrote in an email that  they added a warning about painful sex and other serious side effects to the “instructions for use” in 2009. That was four years after they put it on the market. 

As Melynda was researching, she suspected that like so many other people, the mesh was eroding inside of her. It was hard to find a doctor who knew about mesh injuries and could evaluate her. She finally got an appointment with one of the leading uro-gynocologists on the west coast. 

MELYNDA: I'll never forget her saying to me, I don't know how to tell you this, Melynda. But you have….You have no native tissue left over the apex of your vagina. The mesh had actually eroded any tissue that was left there. So all that was left was exposed mesh that was infected. And that the discharge that I was having was actually puss leaking out of essentially an open wound that I'd had for who knows how long. Those places that I'd been feeling a sharp burning knife pain were actually those locations where the mesh and those nerves in my vagina had been exposed. She said I can cut out the exposed mesh, but this device is so complicated that I don't have the skill set to remove it. And she got tears in her eyes and she said, Melynda, you had no risk factors. None. She said if this can happen to you, it can happen to anyone. 

ALLISON: She drove home.She took the back roads, stopping every 5 or 10 minutes because she was crying so hard.What should have been an hour and a half drive home took her 5 hours.

Removing the mesh would be the only way to stop the erosion and for Melynda to have any chance at relieving the pain. The problem was, manufacturer companies didn’t provide instructions for removing the mesh. It’s an extremely complicated surgery and very few doctors will even attempt it. 

If you can imagine the mesh like a window screen and your body like a patch of grass. It would be like laying that screen on that patch of grass. And then seven years later, trying to remove the screen without damaging the grass or digging up the soil.

So Melynda researched and found some peer reviewed studies about how to best remove mesh. She brought these articles to a doctor in her area.

MELYNDA: And he got so mad at me. He held them up in his hand and he was like, I don't know where you got this junk science from. Dropped it on his desk. He said, but I'm the doctor here. And I said, you know what, we're done. Because by that point in my life, I had gained that sense of power or the ability to know that I don't have to listen to that kind of bullshit. And I literally, I walked out, I said, I'll be calling your front desk and I'll be getting my records. We’re done. 

That meeting with him is the first time ever in my life where I had somebody, a powerful male, in a position of authority who said to me, no, you're wrong. Where I stood up to them and he said, actually, no, I know that I'm right. 

ALLISON: Her faith in the institutions was crumbling. SHE was the one in power now. Melynda talked to 3 more doctors until she found one who she deemed capable of doing the surgery.

Melynda’s removal surgery was even more complicated than expected. The mesh had destroyed Melynda’s pelvic area. All the tissue was inflamed and the mesh had attached itself everywhere. The surgeon had to scrape the mesh off her pubic bone, cut the mesh away from arteries and off the bladder wall. Melynda was losing so much blood that he had to stop the surgery and wasn’t able to remove the last two legs of the mesh — they were threaded through her spine and ligaments. 

At one point, the surgeon thought he’d lost her. When she woke up from surgery, she was in a tremendous amount of pain. But she was overcome by a new sense of clarity.

MELYNDA: Having this profound realization that everything from that moment on was different. That every decision from that point on was going to be a very different one than I'd ever made before.

ALLISON: It was time to take action against one of the institutions that had knowingly made her suffer. She decided to sue Johnson and Johnson. She hired an attorney and began to gather her medical records. 

But when she got the records from the surgery where the mesh was implanted, she had a sinking feeling in her stomach: there at the bottom of all those pages was her signature, consenting to the surgery over and over and over again. She called her attorney.

MELYNDA: I was like, how do I have any case if I've consented? He said, Melynda. That consent isn't worth the paper it's printed on, because they failed to warn you of the dangers and that the product is defective by design. Because you were not told the truth, you could not have given informed consent. Information that would have altered your decision was intentionally withheld from you. 

ALLISON: She was not informed about the risks of mesh — the sexual side effects, the dangers of getting pregnant with the device. She was not informed that it had harmed thousands of women. That it could kill her. She hadn't consented to that. Which means she didn't really consent at all.

MELYNDA: It was like this lightning bolt that just hit me. And I called Jeff and from the other room and I said, Jeff. I said Jeff. Sit down right there. I need to talk to you. I need to talk through this with somebody. Well, what...what does this mean? If I can't give informed consent about mesh because this type of information was withheld from me? Does that mean that I didn't give informed...true informed consent when I terminated my parental rights? He said, no, you didn't, I was just waiting for you to recognize it. 

In both instances I was doing the best I could with the information that I had. The problem is: I wasn't given all of the information. And so I consented to things that I would have never consented to, had I known the truth. 

ALLISON: And the truth was, there had been other options. Melynda could have raised her child as a single mom. She thought about being told that she wouldn’t be able to do it, that to keep her child would be a selfish act. 

She thought back to that LDS counseling session, and the worksheet with the two columns in it. 

MELYNDA: Knowing what I know now. What I would have written down in that column. The bullet point that says love. I would have written down love is enough. Period. 

ALLISON: The mesh removal surgery has improved Melynda’s quality of life. But she still suffers from chronic pain and functionality is disabled. She still needs to have at least three more surgeries to remove the final pieces of mesh that are still in her body. 

Through all of this, Jeff has stayed by her side. She says their heteronormative sex life is non-existen — she can’t have penetraive sex and even being aroused is painful — but that she and Jeff have found other ways to be intimate.

She often wonders about what life would have been like if she’d opted for one of the alternatives to prolapse mesh: like pelvic floor physical therapy or a surgery that uses the body’s own tissue.

Melynda is involved in mesh activism and every week she gets calls from women injured by transvaginal mesh. And unlike Melynda, many of them can’t find a doctor to remove it; or they cannot afford the surgery. 

As of 2020, Over 100,000 women have sued because of mesh and it’s become one of the largest mass tort cases in US history. And many of them have had to sign NDAs — they must agree not to talk abt the case — to receive any payment, which on average is not enough to cover their medical bills and lawyer fees.

Melynda’s lawsuit with J&J is ongoing. But she had had enough of signing away her rights and her voice. She decided she will not sign an NDA. Melynda is now a person who questions authority and listens to herself. Which brought her to another decision.

MELYNDA: I realized that I could no longer be a member of the LDS Church. That issue of informed consent really showed me that it's not me that's the problem, that it's the institution. That's the problem. It left me with a resolve that allowed me to finally stand up to a culture and a religion that I had placed so much value and trust in that I'd sacrificed my...my own daughter to it. It was done and it was very peaceful for me, which is how I knew that it was the right thing. I’m free. 

ALLISON: I think we all want to have faith in something — whether that’s religion or science or something else.

But perhaps the greatest faith we can have is to trust in ourselves.

Melynda has found that faith. 

A few more important things that we need to note.. 

The FDA says that it’s tightening its rules for what kinds of devices can count for the “similar enough” rule and requiring more human clinical trials before allowing devices on the market.

The FDA did eventually take action with mesh: It first issued a public health notification about potential safety concerns of prolapse mesh in 2008. That’s when it began holding public hearings and mandating that manufacturers do studies. But it didn’t ban all pelvic organ prolapse mesh until 11 years after that first health notice….in part because bureaucratic red tape of how long it takes to make regulatory changes.

Over those years, millions of women have gotten pelvic prolapse mesh implanted in their bodies.

In 2012, four years into those FDA health proceedings, J&J stopped selling pelvic organ prolapse mesh — when asked a spokesperson there why, they said, it was not out of safety concerns,  but because there was a decline in quote “commercial viability and worldwide marketing.” 

Other mesh products remain on the market — like for stress urinary incontinence. J&J and others continue to sell mesh for this and other purposes. This mesh is made of the same material and carries a lot of the same risks, like erosion. 

Johnson & Johnson also noted in an email to us that they conducted independent studies that show mesh’s safety and efficacy. Our research shows that many of those studies were conducted after the product was already cleared by the FDA.

Finally, it’s important to acknowledge that for people with severe prolapse, there just aren’t a lot of great options available. Mesh has helped people. But people must get ALL the information about risks and give true, informed consent.

 

Host and Producer: Allison Behringer
Associate Producer: Hannah Harris Green 
Editor: Stephanie Foo
Composer/Sound Designer: Dara Hirsch
Mix engineer: Myke Dodge Weiskopf 
Additional editorial support: Camila Kerwin
Story Consultants: KalaLea, Caitlin Pierce, Cass Adair
Research Assistant: Liz Charky 
Managing Producer: Kristen Lepore

Credits

Host:
Allison Behringer