Enmeshed: Thousands of Women Sue Makers of Transvaginal Mesh

More than 3,000 lawsuits a month are being filed against the makers of transvaginal mesh.

The mesh is causing serious injuries in hundreds of thousands of women across the country.

Enmeshed – A Documentary: The Real Women of Adverse Events from Philip Courter on Vimeo.

There are currently more than 40,000 such lawsuits already filed in multi-district litigation in federal court in Charleston, West Virginia.

And one reporter is covering it day in and day out.

Her name is Jane Akre.

She is the editor of the Mesh Medical Device News Desk in Ponte Vedra, Florida.

“It’s not pleasant to talk about,” Akre told Corporate Crime Reporter in an interview last week.

“Woman have an issue. Things will fall through gravity and through weak tissue, perhaps its weak collagen — things will start falling out of their vaginal canal. It could be their colon. It could be the vagina itself. It could be their bladder or urethra. Things start to sag inside.”

At what age?

“They put mesh in young women too. Some of it is genetic, so it could start happening in your 50s, 60s or so. And if a woman has a hysterectomy, a young woman even, in the past they would tack up the organs just with sutures. And now, prophylactically, they put in mesh.”

What is the mesh made of?

“It is made of polypropylene, which was developed by Phillips Petroleum in the 1960s,” Akre said. “It’s a pretty harsh industrial chemical.”

“There is something called the mesh kit. It’s almost like your hand. It has arms that come out. It’s a flat piece of mesh. And they sew it into the pelvic floor, to shore up everything.”

What’s the problem with the mesh?

“That’s the multimillion dollar question. I suspect because we are seeing systemic problems in both women and men, who have polypropylene mesh for hernias, that it may be the polypropylene.”

“There are six major mesh companies. The four largest are Johnson & Johnson, Boston Scientific, American Medical Systems, and CR Bard. They had sales reps that conducted weekend cadaver clinics, usually in very nice places. And you could fly your family out to Hawaii. You could attend a weekend cadaver clinic. And cadavers didn’t complain too much about the pain. The doctors weren’t all surgeons. In fact, most of them were not surgeons. They showed these doctors how to do a ‘minimally invasive’ surgery that would take about twenty minutes. It would be the bread and butter of your practice. And you could take trocars, which are stainless steel needles and hooks — they look like meat cleavers, or medieval tools — and you could slice and dice and get this stuff in there, through the vagina, in a blind procedure, and pretty much hope that it would be installed correctly. It’s a permanent implant.”

You can’t take it out?

“You can’t take it out. The end of the kits have arms that sink into muscles and tissues. And even the best removal experts, and there are darn few in the country, can’t get the arms out. Women were not told they were having this put in. I can’t tell you how many women say to me — I didn’t even know I had mesh put in me.”

Are you convinced it’s the material itself causing the injury?

“Yes,” Akre says. “I believe it’s the material itself. The industry would say that mesh is inert. The expert in this upcoming trial said — mesh is not inert, it has a systemic response in the body. And early on, he was an advocate of not using mesh.”

What is the nature of the injury?

“A lot of women call me who are in their beds in the fetal position,” Akre says. “They are in so much pain, they can’t move. Some of them make it to pain management. One guy called me because his mother had shot herself before she made it to pain management. She killed herself. You have a generation of women who are hideously mutilated and don’t know what to do.”

How many women have been injured?

“At least 500,000,” Akre says. “And women are contacting me from around the globe. I heard from Zimbabwe the other day.”

Akre says there has been no federal law enforcement action against the mesh makers despite strong evidence of wrongdoing.

“The FDA is asleep,” Akre says. “They are in a very long slumber on this one.”

How many women have died as a result?

“We don’t know,” Akre says.

How many do you know of?

“Three cases, that includes a suicide. But who knows.”

Akre has developed a reporter’s guide to the story, but the press has pretty much ignored it.

“When there is a jury award, outlets like Bloomberg will cover it,” she says. “But that’s about it.”

Why no coverage by television news programs like 60 Minutes?

“I’m perplexed by it,” Akre says. “Maybe it’s because it’s about the vaginal area. One guy at the Globe and Mail in Toronto wrote a story about it, but he first apologized up front because he was going to write about personal things.”

“I think it’s so absurd. We talk about women’s body parts all the time. You have women with the smallest bikinis on the cover of Sports Illustrated. But we can’t talk about these injuries to women?”

“I think this is huge. It’s up there with Vioxx. If I were to guess, we are going to have a multi-billion dollar settlement down the road.”

Akre has started writing a book on the subject. And she has also begun work with Courter Films to produce a documentary titled Enmeshed.

(For the complete q/a transcript of the Interview with Jane Akre, see 28 Corporate Crime Reporter 3(13), January 20, 2104, print edition only.)

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