FDA Assessing Risks of Vaginal Mesh Amid Thousands of Lawsuits

The Food and Drug Administration met again Tuesday over the safety and effectiveness of using vaginal mesh. The FDA has already reclassified the mesh as a Class III high-risk surgical device.

There are more than 100,000 women suing manufacturers over painful complications from vaginal mesh. That makes it one of the largest product lawsuits in history – bigger than the class-action suits over asbestos. Legal verdicts have reached in the hundreds of millions of dollars.

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But some doctors stand behind the product, saying it helps women who need it to repair weakened pelvic tissue, urinary incontinence and prolapse.

Weighing on the latest FDA hearing on the controversial product is journalist Susan Berger, who wrote a story about the issue in the Washington Post.

Below, find an edited Q&A with Berger.

Chicago Tonight: First of all, tell us what vaginal mesh is made of. Is it just a piece of plastic?

Susan Berger: Yes, it's made of a synthetic plastic material that's called polypropylene.

CT: So why are women having this surgery, and what does the mesh do?

Berger: It was introduced in about 1998, and it's implanted in the vaginal wall. It's for women who have stress urinary incontinence. Like when you laugh, you sneeze, you cough, you kind of pee a little bit.

Women who have had babies have this problem. Women just get it as they get older. It could be related to estrogen levels and menopause. There are all kinds of problems. So the mesh is done for stress urinary incontinence is one thing, and the other thing is prolapse. And prolapse is when the bladder is basically getting weak and falling. It needs to be lifted with a sling. The mesh acts as a sling and holds up the bladder, basically.

CT: You've interviewed a number of women. What went wrong when after they had this surgery?

Berger: The stories are pretty horrendous. One woman after the mesh surgery, for two years she had constant pain. She had trouble walking. So I've had women tell me that walking felt like a cheese grater was inside of them. Or like sandpaper scratching them. And some of the women had blood in their urine and had pain when they urinated. There were a whole myriad of problems.

But it's not even just the women. There are people who in my research would say that polypropylene should never be implanted in a human body because it gets hard, it changes to the point where for some women it would come through the vagina where husbands were getting scratched during sex. So it's affecting their partners, too.

I had one woman that I interviewed tell me that she took her husband to her OB-GYN who didn't believe her and her husband showed him where he got scratched. So it's a big problem that it's hard plastic coming through the vaginal wall.

And I had one woman tell me that her gynecologist – and they're in a small town – wasn't really aware of what this was all about – his exam glove was cut during the exam from the mesh.

CT: It's one of the largest lawsuits in history. One of the settlements in in 2015 was for $457 million dollars. This is just one settlement?

Berger: There've been many settlements. That's right. Just last week after my article came out, on Jan. 31, there was a settlement of $41 million to one woman against Johnson & Johnson, the maker of Ethicon, who makes the mesh.

CT: Let's talk about the FDA. They're having a meeting today. Do they think it's safe?

Berger: Well the FDA over a period of time from 2008 to 2010, got 2,800 reports of complications about mesh and that's when they started looking into it. And they actually reclassified this as high risk.

CT: But some doctors are disputing the safety concerns. What did you find out?

Berger: Well, when I did my reporting, I did find doctors who used the mesh and like the mesh and they think it's really good. It solves the problem of stress incontinence for women and their prolapse. And most of the doctors that I spoke to who like the product say the most important thing is to go to a doctor who does many surgeries and who does it often and who knows what they're doing. It's the doctors who don't know how to put it in properly, they contend, that's the problem.

Other experts say, no – it's the polypropylene that changes in the human body and becomes hard and it shrinks and it protrudes through your vagina and all that. So, it's a matter of dispute.

Medicine is supposed to be about risk/benefit. And the numbers here are important because the doctors told me that there have been estimated 4 million women worldwide have had mesh implanted. About 5 percent of them have complications. Well, that equals 200,000 people. And from reading about the complications, half of those people with complications require surgery. And the complications are very hard to get rid of.

The one thing I was told: removing mesh from the human body is like getting bubblegum out of hair. Another analogy I heard was getting rebar out of concrete. So it's a lifelong problem.

CT: It's been banned in some countries, right.

Berger: It is. Australia, Ireland, Scotland and the U.K. have banned it. I believe the UK and Australia, I think they had a rate of 10 percent complication rate even higher than what we're reporting here. But they've also issued public apologies about it. They've banned the product from the market.

CT: So is there a non-surgical way to help with prolapse or incontinence?

Berger: Yes. The doctors who do a lot of the removals who I interviewed, they say there are non-surgical options, including exercise. There are swings that are made from organic and biologic material or come from your own tissues in your own body. That's another way to go. And there's something else called a Burch procedure, which is a surgical procedure.

CT: Are there more lawsuits in the pipeline?

Berger: Yes. There are lawsuits filed by Washington, California, Kentucky and Mississippi against Johnson & Johnson, the parent company of Ethicon. The basis of the lawsuit says that the marketing was deceptive. They accused the company of destroying lives. I mean, it’s pretty strong language, as lawsuits usually are.

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