Bayer Essure: A Device of Torture with No Remedy

A DEVICE PROMISING SAFE, PERMANENT BIRTH CONTROL DELIVERS PAIN, WOMEN SAY

BY AMY SILVERSTEIN   Dallas Observer     WEDNESDAY, JULY 22, 2015

In hindsight, Dr. Shawn Tassone says he and his colleagues were perhaps too eager to implant metal coils in their patients' fallopian tubes.

"We do kind of treat women's health a little bit on the sly here in the United States," says Tassone, who practices at Austin Area Obstetrics, Gynecology and Fertility. "I think if you were to tell men you [were putting] a metal coil in their vas deferens ... men probably wouldn't do it. Like, 'Are you kidding me, you're going to put a piece of metal in my testicle?' But with women, it's just kind of OK."

Like many medical problems that started out as promising breakthroughs, the coils seemed to be a good idea to doctors some 750,000 procedures ago. For years, obstetricians and gynecologists have searched for a way to sterilize women without cutting into them, for a birth control method both permanent and non-surgical. In 2000, a small company called Conceptus said it had the answer: a small coil that looked like the spring in a ballpoint pen, called the STOP-2000. One coil would go in each fallopian tube, causing the tube to react and grow scar tissue, keeping the product in place forever.

The company began testing on women in the United States, England and Australia in 2000. Women who participated in the clinical trials were promised they were taking part in research that would help many others. "At the very least," says an early consent form, "your contribution will benefit the search for a non-incisional way for women to be sterilized."

Several of the women in the trials say they experienced bizarre, painful side effects, but were told they couldn't be caused by the device. Years would pass before they found other women with complaints like theirs, well after the STOP-2000 had been approved by the Food and Drug Administration under a more marketable name: Essure.

Tassone was an early user of the Essure. Initially, doctors were required to test their patients for any allergies to nickel, a component of the coils, but then the company lifted the requirement. "That opened the floodgates; then more doctors were doing it," Tassone says. Conceptus told doctors they could perform Essure in their offices, no hospital visit necessary, making the procedure even more cost-effective. At Tassone's practice, placing an Essure would earn him around $400. The doctors were trained by pharmaceutical sales representatives who are not doctors, a practice health advocates criticize but which the manufacturer defends.

"The sales reps are not required to have any medical degrees, but this is very common in the device industry," says Dr. Edio Zampaglione, an executive and physician at pharmaceutical giant Bayer, which purchased Essure two years ago. "It takes somewhere between six to eight months for these sales reps in the beginning to get internally certified and go out and train physicians."

Tassone volunteered as a consultant for Conceptus, fielding questions from doctors near him, attending conferences and seeking advice from sales people during the procedures. In a span of six years, he implanted the Essure more than 200 times, he estimates. If any women did complain to him afterward, he says he wouldn't have connected it to the Essure.

Then a doctor in Florida called him two years ago. A woman whom Tassone had implanted with Essure had moved there and then got pregnant. The woman's new doctor thought Tassone should know. "I thought the Essure was supposed to be pretty infallible," Tassone says. The call was an eye-opener. He searched the Internet and found Essure Problems, a grassroots Facebook group that for many women has been the only formal recognition of their pain. Every day the group of nearly 20,000 women is piled with new complaints about side effects from the device, many that defy explanation: distended bellies the women developed shortly after getting the Essure, migraines, constant bleeding, pain near their abdomens, skin rashes, lethargy and heavy periods, to name a few.

Some of the complaints women had about their minds and bodies sounded like borderline conspiracy theories to Tassone, but a pattern emerged in many of the reported side effects and medical evidence: Patients have gone so far as to post X-rays in the group, showing Essure devices that had somehow traveled out of their fallopian tubes and into other parts of their bodies, some in their uteri or colons. Spin-off groups were formed for Essure women who got pregnant. Tassone stopped implanting the device and began treating patients who didn't want Essure anymore.

But Essure isn't like other forms of birth control, which all cause side effects for a percentage of unlucky users. Essure is designed to stay stuck in a woman's body forever, embedded in inflamed scar tissue. "There is no good way, from the company, from the manufacturer, to take it out," Tassone says. "You would think that they would devise a way to remove their product that doesn't cause significant damage to a woman."

Or, as the FDA's website explains: "Essure is considered a permanent form of birth control and therefore is not intended to be removed."

So, women who no longer want Essure in their bodies anymore have limited resources beyond a support network of others bitter at the medical system they say failed them.

Dylan Hollingsworth

On the ground floor of the Texas Health Huguley Hospital in Burleson, Dr. Robert Smith advertises his infertility clinic in neon lights. "ESSURE REVERSALS," reads a glowing pink and blue sign on the door. Two paintings hang in his waiting room. In one, a surgeon and his team operate on a patient as Jesus stands behind the surgeon, guiding his hands. The other shows a young, male doctor looking pensively into the distance. Again, Jesus stands behind him.

Smith takes credit for being the first doctor in North Texas to remove Essure from a woman, and, like the doctors in the paintings, he says his hands are guided by something holier than medical science. "To my knowledge, I had, in the DFW area, the first successful removal of the Essure inserts," Smith writes about himself in one of the several books he's self-published about biblical prophecies that Jesus will rise again. "The above is mentioned not for accolades but rather to acknowledge the gifts that God has entrusted to me."

In person, Smith has a friendly manner, less intense than his literature might suggest. He wears a bow-tie and his hair slicked back. A woman's uterus is embroidered above the right breast of his doctor's coat.

Smith isn't ideologically against birth control, he says, nor will he comment on whether Essure is an inherently flawed medical device. His specialty has been reversing tubal ligation, the older, more common and most effective form of female sterilization. He learned how to do Essure reversals more recently, using similar techniques. Before surgery, he asks his patients to pray with him.

Smith is one of the few doctors near Dallas who will operate on women who don't want Essure anymore. On Texas E-sisters, the local spin-off of the national Essure group, the women compiled a list of trustworthy doctors in the state who can take out Essure. The list contains only 15 names. To get doctors and insurance companies to take their complaints seriously, the women advise each other on how to articulate their problems in the physician's office.

"I think there's this sort of underground carrying of information [in the Facebook group] that you're not going to get from looking at your insurance provider directory," says Dr. Eric Sills, an infertility specialist in Carlsbad, California, who has studied the prevalence of pregnancies with the device.

Patients have a litany of horror stories about doctors who unsuccessfully tried to remove Essure: doctors who simply pulled the coils, causing them to break, or doctors who morcellated them, using a tool to grind up the Essure coils that can release metal pieces into the patients' bodies.

"I looked like I had freaking shrapnel in me," says Angie Firmalino, a mail carrier in New York City who founded the Essure Problems group. Many women assume that the only way to get Essure safely out of their bodies is through a hysterectomy, the kind of invasive surgical procedure Essure was supposed to help women avoid. Patients find that many doctors are reluctant to perform the drastic surgery. Woman instead are told to take medication to deal with pain, or are diagnosed with a "hormone imbalance" or other illness.

"The Essure removal by hysterectomy is not a difficult procedure, but what happens is a lot of us get scared, a lot of us don't want to manage patients with the Essure device in place because we've never had to do surgery like that, so we get scared and so we pass the buck to another doctor," says Dr. Julio Novoa, an OBGYN and plastic surgeon in El Paso and one of the 15 doctors whom the Texas E-Sisters recommend. He counsels women for free regularly on Facebook. On his insurance forms, he makes sure to explain the immediate reason for performing a hysterectomy: not the Essure, but the pain in the woman's abdomen.

Dr. Smith, in Burleson, doesn't just offer Essure patients the basic hysterectomy. He also tells women with Essure they could get pregnant again if they undergo a more complicated surgery called the Essure reversal. He is one of only a few doctors in the state to advertise the procedure. It costs $6,000, gets no coverage from insurance providers and must be paid in cash. "I've been burnt by checks, so after a while you just don't take them," he says.

There's no published data that Smith or any other doctor knows of studying the safety or efficacy of Essure reversal surgeries. By Smith's own count, he has performed reversals on 11 women. "My success rate after 12 months of trying is 66 percent," he says of patients who conceived. He acknowledges that Essure patients who do get pregnant face an unknown risk of ectopic pregnancy, a sometimes-lethal type of pregnancy in which an embryo implants itself outside the woman's uterus. In interviews, IVF specialists tend to be more optimistic about the safety of Essure "reversals" than other types of gynecologists. "If the device itself is supposed to cause inflammation and scarring inside the tube, then if you're going to remove the device you're going to have damage inside that tube," Tassone says.

Smith says he closely monitors any patient who does get pregnant, to ensure the fetus is implanted in the right spot. For now, women who pay cash in hope of getting pregnant again must hope Smith's right in his belief he's getting help from above. "I try to represent what Christ has done for me. I try to do that for the patient, and I think by keeping that in focus, that my hands are guided by God," he says. "So I think I have gifted hands and I think that's part of the reason that these reversals have worked."

Dylan Hollingsworth

Maria Rocha stopped by Dr. Smith's office for a consultation, considering the Essure reversal after suffering effects — mainly a huge, bloated belly, bleeding and fatigue — she says the device caused. She also contemplated having children with her fiancé, whom she wasn't with when she got the device two and a half years before. Smith warned her that if she got pregnant, the baby could die unless she underwent a C-section, so she ultimately decided against the surgery.

Rocha was receiving Medicaid benefits when she had the Essure implanted in 2012 and was told by her doctor at a low-income clinic in Waco that he no longer performed tubal ligation. On the day her device was placed, a representative from Conceptus coached her doctor on what to do, she says.

Rocha remembers being surprised by the pain. Later, she ran into a nurse from the clinic, she says, who told Rocha she was one of the first patients her doctor implanted. (His office didn't return messages). She lived with the pain for two and a half years, searching for doctors to help her, until this spring, when, after deciding against the surgery with Smith, she got a hysterectomy from the same doctor who installed the Essure. But he still denies that her health problems are caused by Essure, Rocha says. "He doesn't have an explanation, like why I'm in pain all the time, bloating, why I have periods like twice a month sometimes," Rocha said. Her surgery is in August.

Essure is popular with insurance providers — Medicaid covered about 6,000 Essure procedures in Texas over the last three years, according to data from the Texas Health and Human Services Commission. The ease of getting the procedure can make the patients feel suddenly stranded when they can't get coverage for subsequent complications.

Casey Kummell, an office manager in South Lake, had her Essure procedure in April last year in the same Irving clinic where she gave birth to her children. Kummell was on Medicaid at the time while her husband was unemployed. She wanted to get her tubes tied, but her longtime doctor told her Essure was the better choice.

Kummell read about the backlash to the procedure online and saw that famed but controversial environmental activist Erin Brockovich had started a website against Essure after women in the Facebook group flooded her with mail in a letter-writing campaign. "He said, you know, what a joke all that was, the whole Erin Brockovich stuff, that it's all a joke, all of that can't be caused by this little device," she says, "and so I trusted him."

The procedure was quick and easy, but she developed cramping soon after, a strange pain that felt like being poked with a hot stick. A scan taken by her doctor, which she provided to the Observer, showed that one of the Essure coils had migrated out of her fallopian tube and into her uterus. Her doctor told her he would perform surgery on her for no charge to get the coil out, she says, but the hospital would still charge her $30,000. No longer on Medicaid, she couldn't afford the procedure.

She developed heavy anxiety, fearing she'd need to get a hysterectomy. Finally, nearly a year later, Kummell was able to get on her husband's insurance after he got a new job. The same doctor who installed the Essure performed a complicated surgery to get it out, slicing off a portion of Kummell's uterus but sparing her a hysterectomy. She believes her doctor was genuine when he told her he had never had complications with Essure before.

A pattern of doctors disbelieving patients who complained of side effects began early, back in the clinical trial phase, women say. The Observer interviewed five women who were in post- and pre-market studies of Essure who say they later underwent invasive surgery to get their organs removed. Two provided medical records from their clinical trials.

"We were told it had been passed in the U.S.A. and was new to England. We were in a trial to see if we could get on with our daily lives immediately after," writes Lisa Bennett, a woman in Leeds who says she was part of a clinical trial in 2000, two years before Essure was approved for sale in the United States. Soon afterward, she was in pain and asked for a hysterectomy. Doctors performed the hysterectomy after she demanded it, she writes, but still insisted her pain wasn't caused by the device. Her doctor "was adamant it wasn't Essure related," Bennett says in a message.

The U.S. Food and Drug Administration approved Essure under stringent guidelines called the Class III Premarket Approval process, which is supposed to be so strict that the manufacturers of the device are protected from lawsuits. One attorney in Florida is trying to start a class-action suit anyway. In a petition to the FDA several months ago, his firm includes the medical records of Kim Hudak, one of the clinical trial participants. Several questionnaires in her file show that doctors crossed out answers to her questions and circled new answers. In an interview, Hudak said she recalls filling out the forms herself but with heavy coaching from nurses and researchers, who told her she wasn't suffering any adverse events despite her failing health. Other questionnaires were done over the phone. "I have continued to see doctors of various specialties since 2006, but no one seems to know what is wrong with me," Hudak wrote to her research doctor, Dr. Linda Bradley at the Cleveland Clinic in 2013.

In 2008, eight years after her participation in the trial began, Hudak asked Dr. Bradley for guidance. She was undergoing a removal of one of her ovaries to treat "excessive endometrial growth." She wanted to make sure the surgery was safe to do with the Essure inserts. Bradley counseled Hudak on the phone, she says, and told her to go ahead with surgery.

Shortly after, Hudak received a letter from Cleveland Clinic's Cheryl Williams, clearly indicating the company was no longer interested in hearing from Hudak. "The sponsor has decided to discontinue the study as of December 31, 2008," the letter said. "This means you will not receive any future phone calls or be asked to come in for office visits related to this study." (The Cleveland Clinic says through a media representative: "Our records indicate that the patient voluntarily and actively participated in the STOP-2000 clinical trial from 2000-2008, and both the Cleveland Clinic and the patient complied and completed all study requirements until the study was discontinued by Conceptus in 2008. At that time and with consent, the collected data was submitted to Conceptus for interpretation. Documentation of the patient is consistent with device studies, and the information recorded was provided by the patient.") More recently, Hudak underwent a full hysterectomy.

Dr. Zampaglione, from Bayer, says he reviewed Hudak's records and found nothing wrong. "There were some cross-outs, but those do occur in any kind of medical record, mistakes are made ... what was done was a cross-out and initialing, a cross-out that is 100 percent absolutely allowable and by the book," he says.

Hudak isn't the only participant who believes medical records misrepresented her experience. "A lot of the documents I have were not filled out by me," says Patricia Rhodes, who agreed to join a clinical trial for a free, permanent birth control method in 2000, at the urging of her now ex-husband. She was 24, with one daughter. A security guard then, she had no health insurance, and her then-husband no longer wanted to pay for her hormonal birth control shots. He heard an ad for the clinical trial on the radio. "He's like, 'Hmm ... permanent and free, go check it out,'" Rhodes says.

Rhodes knew she was allergic to nickel, she says, but the doctors told her the coils contained only stainless steel. (The clinic did not return messages seeking comment.)

"I asked them, I don't know, six or seven times, what they were made out of, because I have metal allergies. After six or seven times of bugging the crap out of them trying to find out what [the Essure coils] were made out of, they just told me, 'Oh, they're 100 percent surgical stainless steel,'" Rhodes says. Her clinical trial paperwork similarly shows no mention of any nickel. Essure pamphlets now explicitly warn: "Patients who are allergic to nickel may have an allergic reaction to the inserts."

Her medical consent forms also show no written warnings that the device contained nickel. Zampaglione, the Bayer doctor, said the forms omitted any mention of nickel because patients with nickel allergies were automatically excluded from participation. "If a woman had a nickel allergy, she would have never even made it in the study to sign a consent form,  so that is probably why the consent forms for the very early studies did not have anything about nickel."

Yet during the FDA's meeting in 2002 to approve Essure, representatives from Conceptus told an FDA panelist that nickel coils were safe even for women with nickel allergies. "There was no evidence of local toxicity or local irritancy used with the Essure devices," the representative said to an FDA panelist who asked about nickel allergies. Firmalino, the founder of Essure Problems, obtained footage of the meeting by organizing a fundraiser through Essure Problems and purchasing the copyright from the video company that produced it.

Rhodes says her complications began immediately. She bled for the next six months, felt constant pain in her pelvis and developed urinary tract infections.

"Six months after I got them, I was diagnosed with a hormone imbalance, which I didn't have prior," she says. The clinical trial documents make no reference to any of her ailments. On patient questionnaires from the trial, which Rhodes recently obtained, she is listed as feeling "very satisfied." At the same time, her medical records indicate that over the years she made multiple "unscheduled visits" to the doctor's office for pain in her abdomen. Her health continued to deteriorate, she says. She developed ovarian cysts and new allergies to certain foods and medications. By her late 30s, she says, she felt as though she was going to die. A doctor diagnosed her with porphyria, a rare blood disease.

The investigating doctors studying her told her the problems couldn't be related to the device, Rhodes says. In 2002, another doctor prescribed her 14 different medications to manage the symptoms in her uterus and stomach, her medical records show. That same year, Rhodes' clinical trial documents claim that she found her "comfort wearing the device" to be "excellent." Years later, another woman in the same trial, at that same clinic in Arizona Rhodes visited, would give an interview on a local news station making a similar claim: Her clinical trial questionnaires were wrong — they grossly underestimated how much pain she was in. Rhodes finally found a doctor to perform a hysterectomy in March of this year.

In late June, an FDA representative gave Hudak a surprise call. The agency wanted to invite her personally to attend a public meeting planned about Essure, coming up this September. That same day, on June 25, the agency posted a new, public statement about Essure. People have sent more than 5,093 complaints about the device to the agency's adverse-events database, including reports of pain, fatigue, weight gain, heavy periods and nickel allergies. Worse were four reports of adult women who died, and five reports of fetal deaths. The FDA's announcement came several months after a study from Yale found Essure comes with a 9.6 percent failure rate for women trying to avoid pregnancy — previously, all methods of sterilization for both men and women were thought to have a failure rate of less than 1 percent and Conceptus claimed Essure was over 99 percent effective.

Bayer argues that the adverse events and pregnancies are still low enough for the benefit to outweigh the risk. About 750,000 women have been implanted with Essure, according to figures provided by the company and based on the number of kits sold.

Tassone, the doctor in Austin, recalls implanting Essure in a woman in 2006 and watching her tube spasm without warning. The coil suddenly disappeared inside her body. The sales rep in the room, he says, told him to go ahead and put another coil in. Tassone says he refused, thinking that didn't seem like sound medical device. He monitored the woman, he says, and as far as he knew, she never had side effects.

Now, women will occasionally post to the Essure Problems group post-surgery photos of multiple coils that were retrieved from each tube, rather than the one per tube supposed to be there. "I think I've seen up to five," Tassone says. Zampaglione said he could not comment on Tassone's story but said in some women, it is OK to use more than one coil per tube.

In recent years, Tassone says he has performed about 20 surgeries on women who want the Essure removed. He describes patients with huge, distended bellies that suddenly disappeared after the surgery. Other women have told him they experienced more subtle relief from the removal: more energy, better moods and a clearer mind. Perhaps some of the improvements are a placebo effect, he acknowledges. But he doesn't think that should matter. "The point is, if they say they feel better ... who am I to say that the reason that they feel better is good or bad?"

Email the author at amy.silverstein@dallasobserver.com   Twitter   @AmySilstein

http://www.dallasobserver.com/news/a-device-promising-safe-permanent-birth-control-delivers-pain-women-say-7419165

Lady Parts, Greg Abbott and JNJ Deceptive Trade Practices Mesh Up

 Greg Abbott Not Totally Afraid of Lady Parts,Takes on Big Pharma Over Vaginal Mesh

By Amy Silverstein

Published Fri., Jul. 11 2014 at 7:08 AM

Future Texas Governor Greg Abbott hates nothing more than he hates abortions, Planned Parenthood and other women's-health-related things, leading the Texas Democratic Party to describe him as "public enemy number one for women in Texas." But now, in a major national fight pitting women's health advocates against a corporate giant, Abbott appears to have jumped in bed with women and their bodies.

For the past two years, the Texas Attorney General's office has been quietly leading an investigation into Johnson & Johnson's Ethicon subsidiary, after thousands of women nationwide alleged in lawsuits and complaints to the FDA that the company's pelvic mesh products are defective.

As I reported in a recent feature story on mesh, Ethicon and other companies thought they'd discovered a new, easy way to cure poor bladder control and similar health ills common in aging women and women who have had babies. The fix, rushed to the market in the late 90s, is a surgical device made out of plastic surgical mesh, inserted through the vagina. Patients have complained en masse that the "fix" destroyed their sex lives, worsened their incontinence and caused horrendous pain. More than 17,000 lawsuits have been filed against Ethicon alone.

The FDA was slow to respond, but in 2011 regulators finally issued a warning that complications from some of the mesh surgeries are "not rare." The FDA has yet to issue a formal recall.

Abbott, meanwhile, is investigating Johnson & Johnson under the Texas Deceptive Trade Practices-Consumer Protection Act. In a demand letter sent in April, the Attorney General asked Johnson & Johnson for physical samples of the mesh, detailed data on the material it's composed of, a list of all websites sponsored by Johnson & Johnson discussing the mesh and other data. That's only the latest request for information, following up on a separate demand the Attorney General sent in March 2013. The whole investigation began two years ago, the AG's office tells Unfair Park.

The investigation became public after a group of Texas women wrote a letter to Abbott asking him to crack down on the company, only to find out that he's already looking into it, as WFAA reported.

Women's health aside, Texas and other states have its own reasons to investigate this. "You, as a tax-payer, you're paying for the Medicare patients who have had this thing in," Dr. Daniel Elliott, a surgeon at the Mayo Clinic who treats women suffering mesh complications, told us a few months ago. "Then the patient has all these complications, and you as the taxpayer are paying for their original surgery and you're paying for all these treatments afterwards. It's a huge financial burden on the system."

Dallas Observer: Ethicon and Blue Shit

Women vs. Big Pharma in the BattleOver Trans-vaginal Mesh

A simple procedure was supposed to help fix an embarrassing women's health problem. Instead it left women in pain -- and in a fight for their dignity.

By Amy Silverstein @amysilstein (Twitter)  amy.silverstein@dallasobserver.com (email)
Thursday, May 1 2014

        

Hal Samples

Aaron Horton as her alter ego: the Mesh Warrior.

It felt like fishing line was scratching him: That's how he knew something was wrong. His wife had been complaining for a while that sex hurt, but he thought maybe she just didn't want him anymore. Until, in the act, he felt it himself: something rough and wiry inside her body.

“Problem: Vagina is very odd-shaped, so you cannot use a preformed implant.”

Before the pain, Betty and John (not their real names), just 45 and 54, were the kind of aging but active patients that have been a boon to the medical industry, suffering from an array of maladies but happy to accept whatever treatment was available to keep enjoying life. Betty got her tubes tied in her early 20s, then, after a complication, agreed to get a hysterectomy at just 23. That weakened her bladder, so she got surgery to fix it. After six months, her bladder irritated her just like it had before the operation — always feeling like she needed to pee, leaking when she rushed to the toilet. She tried a second surgery, but that didn't work either.

There were other problems, too. She'd worked in an assembly line years before but quit after she developed carpal tunnel syndrome. Both she and her husband have diabetes. Still, they enjoyed life, staying in or going fishing at a lake near their Missouri home. They always expected to have many more years of sex.

Joleen Chambers

Aaron Horton, left, showed up almost every day to watch the Dallas trial of Linda Batiste, right.

"I'm an old man, but I'm not that old," John says. "It'd be early to be quitting already."

Betty had a guess of what was causing her pain. A few months earlier, her doctor had pitched her on a third surgery to fix her bladder. At the time, in 2004, it was a somewhat new, exciting procedure. The surgery itself would be minimally invasive, and she would leave with a promising new medical implant. "The way he described it to me, it was like a hammock," Betty says.

The hammock didn't bother her at first. But after a few months, she started to notice cramps in her pelvis and sharp pains when she used the bathroom. Sometimes she felt a strange pressure in her lower body. Tired of surgeries, she decided to accept the discomfort. "I'm just going to have to deal with it," she recalls thinking.

But the sex got worse, taking a toll on their love life. John agreed to do an exam of sorts on his wife, thinking maybe it was just some scar tissue. Instead, he found something odd: four plastic strings appeared to be coming out of her body, poking through back of her vagina.

Back at the doctor's office, a nurse took a look and found the cords, too. But if the wires coming out of Betty were strange, the response by the gynecologist who had assisted with the surgery was even stranger.

"There's nothing wrong," John says the doctor told them after taking a look. "I can't find anything."

Answerless, the couple turned to the Internet. It was there that Betty learned she was part of a growing group of women whose "hammocks" were causing intense pain — a pain that doctors, device-makers and the Food and Drug Administration were reluctant to even acknowledge, let alone respond to.

Those "hammocks," it turned out, were actually surgical mesh made out of polypropylene plastic, the same cheap material Betty knew from her fishing lines. She was horrified. She knew how breakable the material was. Yet it was supposed to stay inside of her body for the rest of her life. "If I would have known that ahead of time, I would not have let them be put in me," she says.

Eventually she found a doctor who believed her, she says, who confirmed that the mesh was in fact eroding through her vaginal wall. But the doctor didn't know how to get it out. He offered her some estrogen cream. Betty used up the whole tube in a few months.

She resolved to just live with it, and try to improve her health around the pain. She lost 130 pounds and left the wheelchair to which her diabetes had confined her. Yet sexually, her health deteriorated. She frequently got bladder infections that were passed to her husband, then passed back to her. The cords coming out of her grew longer. To this day, when she sits, it's like sitting on a tack.

Then, a couple years ago, they saw it: a brash, late-night infomercial from a personal injury attorney who was hunting for victims of transvaginal mesh surgery. It wasn't long before they were on the phone, making the same call women across the country have been making, and soon Betty found herself in the same situation: hoping the legal system would acknowledge what their doctors wouldn't.

When you get so old that the Lord lets you pee on yourself, Gynecare can help. That's the way Dr. Melvyn Anhalt explains it, anyway.

"God gave women three mechanisms to be dry," Anhalt said one day last month, testifying in a Dallas courtroom in one of many ongoing lawsuits against manufacturers of transvaginal mesh. Dressed in a crisp black suit with cropped white hair, Dr. Anhalt, in a thick Southern drawl, carefully explained how the female anatomy worked when all its mechanisms were functioning properly. As former head of the Incontinence Center at the Memorial Hermann-Memorial City Hospital in Houston, he understood those mechanisms well.

Gravity takes its toll on all human bodies eventually, but giving birth can wear out the bladder even faster. Young, healthy women who've had children can suddenly leak urine when they laugh, sneeze or exercise, a type of incontinence doctors call Stress Urinary Incontinence, or SUI. Throw in other risk factors like hysterectomies, obesity or smoking, and an incontinence diagnosis is even more likely.

There have always been surgeries to fix incontinence, and whichever method was best depended on the surgeon. A procedure commonly referred to as the "Burch," involving opening the abdomen and stitching loose parts back together, was considered the gold standard by many, but it was technically difficult. Doctors also sometimes took a graft of the patient's own tissue and used it to create a natural "sling" to support the bladder — also a fairly major surgery. Then, in the 1990s, a cheaper solution appeared on the market: mesh.

The material had long been in use to support soft tissues for surgery, inserted through the abdomen to treat hernias. It was Dr. Ulf Ulmsten, a Swedish professor, who discovered that the mesh could be inserted through a woman's vagina, threaded around her urethra and attached to the pubic bone. That meant less time under the knife for the patient and less time in the operating room for the doctor.

Once inside, the mesh theoretically would be held in place by scar tissue. Dr. Axel Arnaud, the Medical Affairs Director for Ethicon, a subsidiary of Johnson & Johnson, traveled to Sweden to watch Ulmsten perform the procedure in person. The surgery was truly a "mini-invasive" one, done in under 30 minutes. "It looked quite easy to perform and was very patient-friendly," he reported in an internal company memo.

The FDA cleared the first synthetic transvaginal sling for sale in the United States in 1996. Ethicon wasn't the first company to come out with its sling, but it soon dominated the market with its "TVT" devices, or tension-free vaginal tape, a similar mesh sling introduced in 1999 under the company's new Gynecare brand.

As the surgery became more common, doctors and device makers pushed to make broader use of it. A few years later, the FDA agreed to let manufacturers sell the mesh to treat a more complex condition: pelvic organ prolapse.

Pelvic organ prolapse, a condition in which a woman's pelvic organs come loose, is traditionally harder to treat than incontinence. But when Ethicon rolled out its product, the procedure became relatively easy. The drug-maker even provided doctors with pre-assembled kits that contained not just the mesh but all of the tools surgeons needed to create a sort of bird's nest to support a patient's organs.

Anhalt, the Houston doctor, was one of many who worked as a consultant for Ethicon, teaching doctors how to implant the slings in training sessions. Soon, the mainstream medical societies agreed: Synthetic slings were the new "gold standard" for treating stress incontinence.

On the witness stand, Anhalt described the invention of the sling in almost biblical terms. "That was the evolution of how the sling came to pass," he said, "that we as urologists and most everybody has determined is the standard of care at this time." Anhalt was talking to a group of 12 jurors in a Dallas County courtroom, for his latest gig: acting as an expert witness for J&J/Ethicon's legal defense team. Linda Batiste, the woman who filed the suit, watched sitting with a pillow on her chair.

"Are you aware of any surgeries doctor, that have no risks?" the J&J attorney asked Anhalt.

"Only surgeries that are not done," Anhalt replied in his folksy manner.

The attorney laughed. "Fair enough, doctor."

One woman was doubled over in pain, holding her hands over her groin, crying hysterically. Another waited outside with her, sitting in a wheelchair. They were close to the University of California in Los Angeles, where they were headed to a doctor's appointment, but not close enough. They needed a ride because they couldn't walk.

Aaron Horton was with them at the time. She'd left the house so fast she was still in her pajama bottoms, suede slippers and a pink T-shirt that read "Trailer Cakes." She frantically tried to hail them a cab.

"No one would help us," she says, with enough distance from the story to laugh about it. When a cab finally pulled over, he was annoyed about the short distance they needed to go and refused to help with the wheelchair. The ride ended, Horton says, with her pointing to UCLA on a map and screaming at him.

They were headed to see UCLA's Dr. Shlomo Raz, one of the few known for being able to remove mesh without hurting patients even more in the process. His schedule is booked six months in advance. Horton didn't need the surgery herself; she was visiting L.A. to do reporting for her blog and offer support for the women.

For 16 years, Horton was gainfully employed in food marketing. She shared a home in Lakewood with her husband. She describes being raised by loving, supportive parents. She was always the "fun friend."

That changed in 2009. Her mom had undergone surgery to repair her pelvic organs. Immediately after, something was wrong. It took the doctors years, Horton says, to admit the same.

She remembers watching her mother sob outside of the doctor's office in 2011, terror in her eyes. "They had to give her IV morphine just to give her a mental break from the pain," she says. Trying to understand what was happening, Horton slowly threw herself into a new passion: learning everything she could about mesh.

She discovered a news site called the Mesh Medical Device News Desk and contributed an emotional story about watching her mother suffer, though careful to protect her mom's identity. The response surprised her: The story generated a flood of calls and emails and 61 thoughtful public comments.

Feeling a new purpose, Horton got to work on her new cause: The Mesh Warrior, a blog that features personal stories about confronting doctors, research news and polls trying to figure out how to organize a local support group.

Horton now spends much of her time on the phone with women too ashamed to talk to anyone else. Their stories follow a disturbing pattern: doctors who won't listen, sometimes family members who won't either. "I can tell you 10 women I can probably think of right now who started off this surgery with three kids, beautiful house," Horton says. Now, "their husband has left them, they've lost their house, they've lost their job because they can't work and now they're on disability and living in isolation in Section 8 housing."

Sandy (not her real name) is one of them. She returned to her gynecologist initially and got no answers, she says. "She did a pelvic on me, and said everything was fine and her work was — I'll never forget this word — 'pristine,'" she says. But there was a strange tailbone and leg pain in Sandy's body that got worse over time. It spread to her back and hips.

Sandy got more surgeries to fix those problems. They didn't work. Finally, she says, a doctor determined it was the mesh causing the pain. Sandy went to UT Southwestern, she says, but the doctors told her the surgery was too risky. She wasn't convinced, so she found another doctor who was willing to take the mesh out. Now the mesh is gone, but it's not clear that she's better off. The surgery left her severely incontinent, with a fistula and pain so intense she can't sit without popping pain pills. Her husband divorced her. "He didn't want to be with a wife who could not have sex with him," she says, crying into the phone.

She lives alone, too ashamed to ask her adult children if she can move in. She's living on her retirement checks but expects to run out of money and isn't sure what will happen next.

Dr. Daniel Elliott, a surgeon at the Mayo Clinic, specializes in removing mesh. He says patients complain "all the time" about doctors who've ignored their pain. "I have a feeling, unfortunately, there are certain individuals who have put this in, they're not high volume [surgeons], they don't have advanced training and then they have a complication and they don't know how to deal with it," he says.

Horton blogs from a friend's barn house in East Texas, where she and her husband spend many weekends. Aside from occasional rifle shots in the background, the land is peaceful, home to a small farm business and trees. She writes from the balcony. For meals, she and her husband visit a local organic restaurant and chat with the owner, a former gynecologist who tried implanting mesh once and didn't like it. "To me, it looks kind of like, what's that material? A body scrubber thing," he said one recent afternoon.

When she's not writing, she's drumming up support, teaming up with Joleen Chambers, another Dallas-based patient advocate, and Hal Samples, a Dallas photographer who suffered complications when he got mesh for a hernia surgery. To show his gratitude, he gave Horton a free photo shoot. She asked to be made up in blue makeup, like a feminine warrior. Before the shoot was over, she bought some textiles from Home Depot and tore them up, giving the material the appearance of mesh. She stuck it over her lips for the final picture — the photo she uses on her Mesh Warrior site. "I said, 'I've got to have this picture because this is how these women feel,'" she says. "They feel silenced."

She's trying to get a formal foundation going too, and has had meetings so far with Consumer Reports and the UCLA marketing department. But mostly she's a welcoming ear to patients with no one else to turn to. A welcome ear and a comfortable couch in Lakewood, where she's let more than one plaintiff crash when they've come to Dallas to watch the mesh battles play out in court.

One day in 1998, a young pharmaceutical rep showed up at Dr. Tom Margolis' office, pitching him on a new device. The rep wanted Margolis' business, badly. "I said, 'Nope, no way,'" Margolis recalls. "I told him that they were going to have all sorts of problems."

Whatever those problems would be, doctors wouldn't know until it was too late. Unlike drugs, the Food and Drug Administration allows any device on the market if the company argues that it is "substantially equivalent" to an existing device — no clinical trials required. A recent report from the Institute of Medicine called the FDA's device-regulation procedure "fatally flawed." But no matter: Transvaginal mesh went straight to market without trials.

"The way they've set this up legislatively, it's making it very profitable for these companies to continue putting out any kind of implant [on the market] and innovate on them and not have any requirement to prove it with patient outcomes," says Joleen Chambers, a Dallas-based patient advocate who blogs at the FAILED Implant Device Alliance.

The problems revealed themselves quickly. First was the fact that the product was inserted through the vagina, an organ doctors say can't be sterilized like the abdomen can. Even in the early years, mesh manufacturer Ethicon knew how problematic that would be.

"It was broadly admitted that the use of any mesh through a vaginal route was associated with a high rate of complications," the company's medical affairs director, Axel Arnaud, wrote in a memo. Yet he ultimately decided to trust the sling inventor and sign a deal with him.

Anhalt, the Houston doctor, was one of the early sling users. The first plastic transvaginal sling, called the Protegen, was marketed by a company called Boston Scientific. Anhalt implanted a woman named Patricia Joyce with it in June 1997, after she complained about her incontinence.

Yet several weeks later, Joyce couldn't urinate. She went back to Anhalt, who concluded that he may have placed her tissues "too high" but that he would wait another month before doing anything, she later argued in court papers. He performed surgery on her again, cutting part of the sling to loosen it "in attempt to allow the bladder and the urethra to come down to a more normal position," her lawsuit says. In December, Anhalt performed a third surgery to remove the scar tissue. Joyce finally left him and went to another doctor the next year. The new doctor said she had a hyper-suspended urethra and performed three more surgeries to try fixing it. (The suit was settled in 2001. Dr. Anhalt did not return messages seeking comment.)

Joyce's problems were hardly unique. In 2000, Boston Scientific announced that it was recalling its sling, citing a high number of customer complaints. Yet dozens of other companies, including Ethicon, were able to keep their slings on the market without FDA scrutiny, even though they shared many characteristics with the Protegen sling.

And they worked hard to make sure doctors kept using them. In 2000, Lisa Kwiatek, Ethicon's Director of Incontinence, ordered sales reps to get in touch with surgeons presenting at that year's American Urogynecologic Surgeons. She wanted to make sure they wouldn't make any "incorrect statements."

"Let's do what we can to make sure what is being presented is positive to TVT," she wrote, "and alert me to potential challenges."

Greg Slusser, Ethicon's Eastern Regional manager, forwarded the message along to employees. "The only way to ensure this is to talk to your doctors who will be presenting," he wrote, apparently referencing doctors who had been employed as Ethicon consultants. "If any concerns are identified, let's get them back on the TVT bandwagon prior to the meeting before they can negatively impact the attendees who attend their lecture."

It was 2000 when Ethicon first learned that its TVT products had a tendency to break off in pieces of lint and rope, potentially sending pieces of plastic through women's bodies. By 2003, Ethicon reported having received 58 complaints about fraying mesh.

"Fraying is inherent in the design and construction of the product," wrote Marty Weisberg, Ethicon's Senior Medical Director, in a company memo. He decided, however, that fraying wasn't necessarily a bad thing. "There is no reason to expect that the fraying of the mesh or the particles generated would create any safety risks," he wrote. As a result, "it has been determined not to pursue any corrective actions at this time."

When Ethicon introduced a TVT product in a blue color the next year, the fraying became more obvious. "Already at the operation it is embarrassing to see how the tape is crumbling," Dr. J. Ebard, a German doctor who consulted with Ethicon, complained to the company in a 2004 email. With the blue color, he said, "everyone has realized that the quality of the tape is terrible."

In 2004, Gynecare's Research and Development head Dan Smith got word that two more doctors had complained about blue plastic particles. He wasn't surprised. He'd warned them — not that it wouldn't work, but that they shouldn't make the problems so obvious.

"This is not going to go away anytime soon and competition will have a field day," Smith warned in an email. "Major damage control offensive needs to start to educate the reps and surgeons UPFRONT that they will see BLUE shit and it is OK. This is why I wanted to launch TVT-O in clear!!!!"

There was also dyspareunia, the medical term for painful sex caused by the mesh. Before a company clinical trial was scheduled, Ethicon employees searched for a way to avoid discussing that undesirable side effect.

"I ACCEPT THAT WE NEED TO REPORT THE CASE OF DYSPAREUNIA BECAUSE I WOULD AGREE IT WOULD BE UNETHICAL NOT TO MENTION SINCE WE KNOW ABOUT IT," Kimberly Hunsicker, Ethicon's Research Operations Manager, wrote in 2004. "HOWEVER THE WAY IT IS PRESENTED IN THE ABSTRACT IS GOING TO KILL US."

In a follow-up note, she added that dyspareunia data are low in the study because it is a self-reported adverse event and not part of the questionnaire given to patients. Her solution was to keep it that way: "To my knowledge, we will not have 'solicited' information (questionnaires) on dyspareunia at the end of the trial."

Patients who suffered complications could report it through the FDA's adverse event database, a voluntary system that provided the only legitimacy for many patients. In the public database, Ethicon responded to the complaints with the same refrain: No conclusions could be drawn. But behind closed doors, Ethicon worked closely with surgeons to figure out how to improve the mesh.

"Need to learn more about special anatomic features in the vaginal region," read company notes from a 2007 "brainstorming session" with surgeons. Apparently, the human vagina was something that was eluding a few of the gynecologists Ethicon had met with. "Problem: Vagina is very odd-shaped, so you cannot use a preformed implant," the report adds.

Finally, in 2008, the FDA took action, albeit minor. It posted a warning online about mesh use for POP and SUI, issuing a broad statement: "Over the past three years, FDA has received over 1,000 reports from nine surgical mesh manufacturers of complications that were associated with surgical mesh devices used to repair POP and SUI," the FDA's notice says, adding that adverse events were "rare" but serious.

Carolyn Lewis didn't see that report before she agreed to get a sling in 2009. It didn't get much publicity, and she trusted her doctor enough not to fact-check her words online. A housewife from Corsicana, she traveled to Dr. Muriel Boreham's office at Baylor to do something about her leaking, and circled "yes" three times in the medical form when asked if she'd consider surgery, court records show.

Under the knife, Lewis' bladder was accidentally perforated — twice. (In a court deposition, Dr. Boreham blamed the accident on a physician's assistant. She didn't return messages.) That was another issue that became apparent with the slings: the "blind" angle at which surgeons inserted them, combined with the seemingly easy nature of the surgery, had created a potentially dangerous situation in which some doctors didn't realize that they were in over their heads.

In 2011, Ethicon interviewed surgeons to investigate why erosion was happening so often, with the pelvic floor surgeries in particular. According to company documents, the surgeons "maintain that mesh is sometimes used in cases where it is not necessary by an enthusiastic but less skilled general gynecological surgeon."

"What I would say is that the industry is guilty of making it [the surgery] look awfully easy to doctors," acknowledges Dr. Brian Feagins, founder of the Dallas Center for Pelvic Medicine and a consultant for pharmaceutical companies that sell the devices. Feagins has taught how to implant the slings at courses with catchy titles such as the "Sling-a-thon" and remains confident in his skill level, telling patients that they risk just a 4 to 8 percent complication rate. "Mesh is still an excellent tool when used in the right situation by the right doctor. That's why I keep using it."

Eventually, Ethicon would improve its mesh products, introducing a thinner, softer plastic cut with lasers that didn't leave particles in the operating room. The company never recalled the original mechanically cut mesh, instead leaving both on the market at the same time. An Ethicon marketing executive wrote in 2005 that "we do get a high number of complaints on linting and roping" on the older mesh. She asked for help telling "a nice story without overtly admitting that the current product may have some perceived aesthetic problems (not clinically relevant)." (In a statement, an Ethicon spokesman said "millions of pages of documents have been provided" and "selective disclosure of certain sentences or phrases without proper context can be extremely misleading.")

Yet research still showed problems with the newer mesh, and Ethicon kept investigating. Ethicon had donated its POP kits for researchers to study erosion. In a 2010 study, the researchers reported that after just three months, 15.6 percent of the women had suffered the complication. The trial was halted early for ethical reasons.

The FDA took notice and, in 2011, issued a new statement about mesh, zeroing in on its use for pelvic organ prolapse. Complications from that procedure, the FDA warned, were "not rare" after all. Still, the agency never demanded a formal recall. Instead, Johnson & Johnson quietly took its mesh for POP off the market the next year, describing it as a business decision. Mesh for incontinence remains available, with the FDA still not issuing a clear guideline on whether those complications are also rare.

The industry is clinging to the idea that mesh for incontinence is very different from mesh for POP. And doctors are following that lead. The American Urogynecologic Society has acknowledged problems with mesh for pelvic organ prolapse but has stood firm in its support of the mesh for incontinence. It blames lawyers and the media for creating "confusion, fear, and an unbalanced negative perception regarding the midurethral sling as a treatment for SUI [stress urinary incontinence]." Then again, half of the AUG board members have disclosed business ties to device manufacturers.

"They are not just apples to oranges, they are apples to watermelons. It's completely different," says Dr. Cheryl Iglesia, a urogynecologist who helped craft the FDA's 2011 statement, and had also led the study showing a 15.6 erosion rate in Ethicon's pelvic mesh.

The doctors at UT-Southwestern share her philosophy. "Nobody in the Urogynecology division here at UTSW uses transvaginal mesh devices for POP," UTSW surgeon Dr. David Rahn writes in an email. He defends mesh use for incontinence, adding: "In general, I find that patients are now very fearful of all vaginal meshes used for SUI and POP, which is unfortunate because there is a substantial difference between the two."

But medical literature and lawsuits describe women injured by both types of implants. Dr. Elliott, from the Mayo Clinic, and Dr. Margolis, the California doctor, say they remove both types of mesh in the complicated explant surgeries, at least when it's possible. Most recently, Dr. Elliott said he saw an older woman in horrible pelvic pain from prolapse surgery whom he didn't feel comfortable operating on. "She can't sit, she can't lie down, she can't walk because of pain following a mesh surgery, and we don't have a fix for her," he says. "That's it."

Adds Margolis, the mesh critic: "The sling is like plastic chicken wire. Once it's embedded into the vagina, and once it's scarred into place, it or portions of it are part of that woman for life. You can't get it all out."

One morning in March, Linda Batiste walked slowly through the courtroom, using a cane for support. Her team of attorneys and their young paralegals helped her get the door. At 64, Batiste, who lives in South Dallas, has had a long life of health problems. In her 20s, she was diagnosed with endometriosis, a painful condition in which the lining of the uterus grows into other parts of the body. She'd had a hysterectomy, back surgery and heart surgery. Though not overweight, she suffered from diabetes and a history of strokes. She continued to smoke cigarettes through it all.

Still, life wasn't about just coping. She had a boyfriend, and they talked about getting married. That was back in 2011. It was around then that she visited Dr. John McNabb at Baylor to do something about her stress urinary incontinence. His solution: an Ethicon sling, called the TVT-O.

Afterward, sex became too painful and her incontinence got worse, she says. She sued Ethicon and its parent company, Johnson & Johnson.

It's a common tactic. The FDA's 2011 notice put personal injury attorneys on alert. Drug attorneys found thousands of new, desperate, angry customers. Infomercials urged women who received "transvaginal mesh" to call the hotline immediately.

So many women signed up that the courts decided to consolidate most of the cases in West Virginia, before a single judge. He's now responsible for more than 17,000 lawsuits just against Ethicon. The suits against other device manufacturers, including Boston Scientific, American Medical Systems and C.R. Bard, are also in his court, bringing the grand total of pending pelvic mesh cases to more than 50,000. A few of those cases have been heard, but delays plague the West Virginia system. Most recently, Carolyn Lewis, the woman from Corsicana whose bladder was perforated at Baylor, had her trial in the West Virginia court. But before the jury could even deliberate, the judge sided with Johnson & Johnson and tossed the case.

The Batiste case managed to escape that slow system, instead ending up in Dallas County Court. The proceedings provided a rare preview of how thousands of other mesh trials may play out.

On the witness stand, Anhalt reviewed Batiste's medical records for the defense. Young men and women in business suits typed furiously on their laptops behind the Johnson & Johnson attorneys as Anhalt discussed her bathroom habits and other health ills.

Johnson & Johnson's lawyers unsuccessfully tried to introduce an apparent sexual abuse Batiste suffered from more than 40 years ago into evidence. In videotaped deposition, they grilled her former fiancé about how many cigarettes she smoked. Under cross-examination from Batiste's attorneys, he said they broke up after the sex wasn't possible.

"I love her, but not like I used to," he testified, blaming it on "the problems she's having downstairs with that mesh."

Horton, the Mesh Warrior, came to the trial with Chambers, the local failed device implant advocate, almost every day, and waited in the courtroom as the jury deliberated. In April, they made their decision: Johnson & Johnson owed Batiste $1.2 million in damages. It was a rare victory for the injured women. "Great day for #American #JUSTICE!!," Horton tweeted.

Johnson & Johnson does not seem concerned. In 2012, it warned investors about the growing litigation, but added: "The Company believes that the ultimate resolution of these matters ... is not expected to have a material adverse effect on the Company's financial position."

FiDA comment

If U.S. justice does not extend to profiteering medical providers and CEO's of medical device manufacturers that cannot clinically prove the value of the products to human health, PREVENTABLE harm will increase and the cost to our nation will be quickly unsustainable.  Why isn't PCORI (patient centered outcomes research institute) funding grants that compare implanted medical device outcomes?  Why does FDA only legally require surgeons to report fatalities as an adverse event?  Why isn't a MSDS (materials safety data sheet) a part of informed consent?  Why doesn't CMS require the implant manufacturer to provide a basic product warranty?  Why can you knowingly torture human beings with these implants with the assurance that you will see no jail time?  Why is protection inherent to the corporation but so illusive to the harmed individual?