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?