The Food and Drug Administration has issued a new warning about a medical device many say never should have been implanted in millions of women. In January, the FDA re-classified transvaginal mesh, a small piece of synthetic material similar to a screen door that’s implanted via the vagina, to help treat women who suffer from incontinence or shifting pelvic organs, a condition more common with age and after multiple child births.
Also called TVM, pelvic mesh, or a bladder sling, the FDA now considers the device “high risk,” for use in the repair of “pelvic organ prolapse” or POP. The FDA’s order does not apply to mesh used as a fix for stress urinary incontinence or SUI.
However, in both procedures, thousands of women have reported health complications to the FDA about mesh, including complaints the mesh causes infection, chronic pain, and painful sex.
This type of surgical mesh was introduced in the 50’s to fix hernias via abdominal surgery. But in 2002, the FDA cleared mesh for use in repairs of POP. That’s a condition where weak pelvic muscles allow organs like the bladder or uterus to move out of place. The FDA is now requiring manufacturers who want to continue selling mesh for prolapse to submit new data showing the mesh is safe and effective for the repair of POP.
Over the past few years—using mesh became popular as a way to fix incontinence too, because the procedure doesn’t require surgery; instead doctors go through the vagina.
That’s why Bay Area women Kerry Hanchai and Rita Morrison had it implanted. Both say they were told by their doctors it would be a simple procedure, minimally invasive, and wouldn’t require a lengthy hospital stay.
But both women say the mesh left them with debilitating pain and infections within months.
“It seemed safe, it seemed easy” Morrison said.
And at first it seemed to work.
“It was simple, it was quick, I went into the hospital the next day I came home and was back up on my feet,” Hanchai said. “It’s a nightmare, I had it put in in 2012, and since then I’ve had 5 to 6 UTIs (urinary tract infections) a year.”
Morrison said she used numbing medicine constantly, “I literally sat in the bathtub all night long sometimes because it was so painful.”
Bay Area resident Ronda Rayburn was also implanted with mesh. She said her doctor advised her to try TVM for organ prolapse. But like Hanchai and Morrison, she said the mesh caused more pain and problems than her original condition. And all three women told NBC Bay Area the risks and complications from mesh were never explained to them.
“It feels just like a, a screen, you know from a window, that’s on my insides and cutting me from the inside,” Rayburn said. A pain so debilitating, she’s speaking out to warn other women. All three say they want the FDA to ban TVM and take it off the market immediately.
“Just get rid of it. Why would you even think about putting it in another person?” asked Rayburn.
TVM has been sold to millions of women for years, and resulted in thousands of complaints to the FDA about severe health problems including “infection, pain, urinary problems, and recurrence of prolapse and/or incontinence.” The FDA notes women also reported vaginal scarring and mesh erosion that led to “a significant decrease in patient quality of life due to discomfort and pain,” including extreme pain during sex.
“If this was a bunch of men who couldn’t use their reproductive organs, believe me there’d be more noise about it,” said Jennifer Stanich Banmiller, CEO of Wingtip Communications. Her law firm marketing company runs a call center that takes calls from women around the country, around the clock to explain their legal and medical options, and connects them with law firms that may be able to help them sue for damages.
“The pharmaceutical companies are making money off this mesh that you can buy for $25 but they’re selling them for about $800 to $3000 so it’s so lucrative,” Stanich Banmiller said, “What’s a woman worth? What’s a vagina worth?”
She estimates roughly two million women have been implanted with mesh, which is still on the market.
But thousands of women are now turning to surgeons like Dr. Dionysios Veronikis in St. Louis. He’s performed more than 1,000 mesh removal surgeries since 1994, and said he’s seen a rapid increase in patients over the past 5 years. Women have travelled from as far as Australia to have the mesh removed, a process some doctors have described as taking rebar out of concrete.
He called this “the darkest chapter in gynecologic surgery,” and urges women who are suffering to seek treatment from experienced surgeons.
“I don’t want them live in hopelessness, but they need to seek out physicians that have expertise in taking care of these mesh issues,” Veronikis said.
Dr. Veronikis has served as a paid expert witness for plaintiffs in litigation over pelvic mesh.
In 2011, the FDA asked Bay Area surgeon Dr. Tom Margolis to testify. He said he paid for his own travel and lodging to Washington, DC, where he urged the FDA to take “firm action” to save women from further suffering. His testimony said mesh “produces an unacceptably high and clearly avoidable plethora of life-ruining complications in women, and there are numerous safer surgical alternatives with superior success rates.”
Dr. Margolis has also testified as a paid expert witness for plaintiffs in ongoing litigation related to pelvic mesh, each time testifying under oath he has been paid to provide his objective medical opinion regarding injuries sustained by women from what he calls a “defective product.”
The FDA has issued two warnings about transvaginal mesh since 2008:
NBC Bay Area reviewed the FDA’s product monitoring database and found more than 3,000 complaints against nearly a dozen different makers of mesh products.
Some of the biggest manufacturers, including Johnson & Johnson, Bard, and Boston Scientific have defended their products in court, contending these devices have been rigorously tested and proven to help women repair prolapse. They argue their products are FDA-approved and the agency has not requested they pull them from the market.
In a statement, Ethicon, a subsidiary of Johnson & Johnson, said it “empathizes with all women suffering from pelvic organ prolapse and stress urinary incontinence, conditions that can be serious and debilitating, and we are always concerned when a patient experiences adverse medical events. Ethicon is committed to advancing the standard of care for women's health and will continue to offer safe and effective treatment options for women suffering from pelvic disorders. We have always made patient safety a top priority and will continue to do so.”
The company said it is defending itself in ongoing litigation but “confident the evidence will show that Ethicon acted appropriately and responsibly in the research, development and marketing of its pelvic mesh products.”
The company said it discontinued selling transvaginal mesh for use in POP repairs in June 2012, but that its mesh products are still being used for stress urinary incontinence (SUI) procedures.
Ethicon’s full statement is at the end of this article.
The continued use of mesh frustrates women like Hanchai, Morrison, and Rayburn. They say the FDA’s warnings simply aren’t enough to protect women, or inform them, about the risks from transvaginal mesh, and they want the product completely banned.
“I would like them to not use it. I would like them to know that the traditional old style of how to fix a bladder [with abdominal surgery.] I know that they say that it’s more recovery time…but if it’s more recovery time now, it’s not going to affect your entire life,” Hanchai said.
She and Rayburn are now suing the makers of their devices.
“They should pay the medical bills, they should help the women out that they injured,” Hanchai said.
An estimated 100 thousand women are now part of dozens of lawsuits against mesh makers. Under the FDA’s current rules—mesh will remain on the market until 2019 listed as a high risk medical device in the repair of prolapse.
The FDA encourages women to report any problems with mesh:
You can report directly to MedWatch, the FDA Safety Information and Adverse Event Reporting program online, by phone at 1-800-FDA-1088, or obtain the fillable form online, print it out and fax to 1-800-FDA-0178 or mail to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787.
Pelvic mesh products have been used as surgical treatment options for two different conditions: stress urinary incontinence and pelvic organ prolapse. These are common, treatable conditions that can be serious, debilitating and have a large impact on a woman’s quality of life. Some women with these conditions can be treated using non-surgical approaches, such as pelvic floor exercises, but for some women, the extent of their condition means that only a surgical option may result in improvement.
Current Market Status of Ethicon’s Pelvic Mesh Products
The TVT devices Ethicon markets today are considered by many, including most doctors who treat stress urinary incontinence, to be the gold standard for the treatment of stress urinary incontinence. The American Urogynecologic Society and the Society of Urodynamics, Female Pelvic Medicine and Urogenital Reconstruction issued a position statement in January 2014 saying, “The polypropylene midurethral sling has helped millions of women with stress urinary incontinence regain control of their lives by undergoing a simple outpatient procedure that allows them to return to daily life very quickly. … This procedure is probably the most important advancement in the treatment of stress urinary incontinence in the last 50 years and has the full support of our organizations which are dedicated to improving the lives of women with urinary incontinence.”
In June 2012, Ethicon announced a business decision to discontinue the global commercialization of some of its pelvic mesh products, including all transvaginal mesh devices used for the treatment of pelvic organ prolapse. Our decision to discontinue these products was based on their commercial viability in light of changing market dynamics, and was not related to the safety or efficacy of the products.
Calls by individuals to remove pelvic mesh products from certain markets are not supported by clinical evidence and research and would restrict access to important treatment options for women suffering from serious pelvic conditions.