A vaginal device used to shore up sagging organs is causing injuries

Rhonda Olson tried to do her homework before she let a doctor permanently implant mesh in her pelvic region to shore up sagging organs. She read up on mesh treatment for what is called pelvic organ prolapse and saw some reports of problems.

She questioned her doctor. "This new mesh is safe," she says he assured her.

It was not.

Last month, the U.S. Food and Drug Administration ordered mesh products for transvaginal repair of pelvic organ prolapse off the market. The FDA said neither of the two companies that still sold it, Boston Scientific and Coloplast, had demonstrated that mesh was more effective or safer than using a patient's own tissue.

The FDA's action came too late for Olson. The 47-year-old mother of four from Ham Lake suffered irreversible damage from vaginal mesh. She required risky mesh removal surgery and still lives with pain that forces her to take $300 a month worth of medical marijuana to continue working. She feels betrayed by the FDA, her doctor and makers of vaginal mesh products.

"If they had done more testing, I think I would not be where I am," Olson said. "It makes me mad that I was a guinea pig to the mesh industry."

Hundreds of thousands of American women have been injured by mesh used to treat their pelvic regions for sagging organs or incontinence. Nationwide, more than 125,000 have sued, according to Jane Akre, a journalist who runs a website that tracks mesh news. Tens of thousands of women have agreed to legal settlements collectively totaling billions of dollars. But many say their individual settlements are far too small to compensate for injuries that will lead to lifelong suffering.

New Zealand recently banned vaginal mesh. Britain has widely restricted its use. In the United States, the FDA issued a warning in 2011. But it took eight years to stop sales of some vaginal mesh, and even then, the agency did not restrict sales of mesh products used to treat stress urinary incontinence. Those products make up the majority of pelvic mesh procedures and have spawned tens of thousands of injury complaints and lawsuits.

FDA spokeswoman Deborah Kotz says the agency moved as quickly as it could against vaginal mesh used for pelvic organ prolapse, in which age and child birth cause bladders and other organs to sag into the vagina.

"Congress enacted a risk-based framework that FDA has been applying," she told the Star Tribune in an e-mail. "The real issue is that the statutorily mandated process can take several years and extensive resources to pursue reclassification."

Boston Scientific and Coloplast have objected to the FDA restrictions.

Coloplast CEO Kristian Villumsen said the Danish company, which has its U.S. headquarters in Minneapolis, had "not yet had sufficient time to collect long-term data."

Boston Scientific, which has more than 5,000 employees in Minnesota, said sales restrictions "will severely limit treatment options for the 50% of women in the U.S. who will suffer from [pelvic organ prolapse] during their lives."

Women who have had bad experiences with mesh products question why the FDA didn't act much sooner. Some criticize an FDA approval process that enabled products that hurt them to be sold without premarket testing that other products require.

The FDA is supposed to protect the public, said Kelli Page, a mother of four from Indiana. She and other mesh victims proclaimed May 1, 2019, "Mesh Awareness Day." Page said she struggled to find a physician to remove the mesh that her body rejected because the federal Medicaid and Medicare programs have no specific reimbursement code for mesh removal.

"My government could have done something to protect me, but it didn't," she said. "[The FDA] is failing to do their job."

From 2002 to 2013, the FDA approved more than 100 vaginal mesh products without requiring safety and effectiveness testing, pronouncing them "substantially equivalent" to devices already on the market.

The substantial equivalence medical device approval process was designed to get less dangerous devices to market quickly and cheaply. It has been applied to millions of devices. In 2016, roughly 60% of all U.S. device submissions sought approval as substantial equivalents, according to a study by the device consultancy Emergo.

"It doesn't make public health sense," said Dr. David Challoner, the physician who led an Institute of Medicine (IOM) team that examined substantial equivalence for the FDA in 2011. The panel recommended that the program be scrapped.

Once the FDA approves a device, doctors can use it in any way they think will help patients. When physicians started using general surgical mesh to treat pelvic organ prolapse and incontinence in women, manufacturers saw a potentially lucrative market. In 1996, the FDA pronounced the ProteGen Sling, a vaginal mesh made by Boston Scientific, substantially equivalent to general surgical mesh from the 1950s.

The ProteGen Sling became a substantially equivalent device that many device makers used to get their products approved, even as Boston Scientific voluntarily recalled it in 1999 because of injury complaints. In 2002, Ethicon Inc. got Gynemesh, a pre-cut vaginal mesh, approved by the FDA as equivalent to a product sold before device testing laws changed in 1976. In Minnesota, American Medical Systems received approval for the first pelvic organ prolapse repair kit in 2004. Dozens of companies fed off each of these approvals to ask for substantial equivalence for their vaginal mesh products.

With device makers lobbying hard to keep the process, the FDA did not take the advice of Challoner's committee and scrap the substantial equivalence process in 2011. Vaginal mesh continued to be implanted.

Tammy Lindberg of Cambridge, Minn. said the doctor who implanted her with an Ethicon mesh five days after the 2011 FDA warning never mentioned it. The doctor had recommended mesh to treat Lindberg for occasional urinary incontinence. The implant led to recurrent infections, acute pain and auto­immune problems.

As her pain grew unbearable and a 2012 surgery to remove the mesh failed, Lindberg could not find relief. When she complained to a nurse that she hurt so much she felt like killing herself, Lindberg said she was placed in an ambulance and driven from a hospital in Wyoming, Minn., to a psychiatric facility 30 miles away in St. Paul.

Her husband, John, chased the ambulance and persuaded officials at the psychiatric facility to release her. She still lives with pain and anger.

"I was dehumanized and treated like I was crazy," Lindberg said. "Even now, if I ride too long in a bumpy vehicle, I'm bleeding [vaginally]."

In 2016, the FDA began a yearslong series of steps to reclassify certain kinds of vaginal mesh as devices that had to prove safety and effectiveness before being sold. This April, the agency issued a stop-sales order to remove the last transvaginal mesh for pelvic organ prolapse from the market.

The order did not include mesh slings for treatment of stress urinary incontinence that make up the bulk of vaginal mesh procedures.

For instance, Boston Scientific sells about $100 million worth of mesh products per year, according to a spokesman. The FDA restriction covers only about $25 million of those sales, Boston Scientific said.

The FDA's Kotz said the agency has ordered 14 post-market studies on stress urinary incontinence slings. But those slings, she said, remain a "gold standard" supported by "all of the major urologic and gynecologic societies."

Dr. Michael Carome, health research director for the consumer group Public Citizen, finds it outrageous that mesh sales to treat urinary incontinence continue even though thousands of women continue to claim injury.

"We have a bar to bring devices to market that is incredibly low," Carome said. "When problems start, the bar to get them off the market is incredibly high, almost impossible. That's a horrible recipe for protecting public health."

Heather Richter, 49, said mesh for urinary incontinence developed by C.R. Bard caused her vaginal wall to erode and put a hole in her ureter, the tube that guides urine from the kidney to the bladder. Still, the Dodge Center, Minn., woman counts herself lucky. A mesh removal specialist in St. Louis was able to get all of Richter's mesh out.

Richter said the doctor who removed the mesh told her she had urge incontinence, not stress incontinence, and did not need the mesh in the first place.

Anissa Brown of North Carolina was not so fortunate. Brown, 47, said doctors surgically implanted Boston Scientific mesh in her pelvis in 2012 to support her bladder after the births of two children. In 2016, other doctors had to cut out as much of the mesh as they could to relieve scarring and bladder damage that caused chronic, excruciating pain. Parts of the sling remain inside her because they are too dangerous to remove, she said.

To function, she needs daily doses of opioids, as well as bladder stretching therapy and shots in her pelvic floor. She cannot walk far and generally must remain sedentary to be comfortable.

Adding to her frustration, the FDA's new sales restriction does not cover the mesh product that crippled her. Other women can still be hurt as she was if they use mesh.

"I thank God I'm alive to tell people on Facebook to use your own tissue," she said.

AdvaMed, the largest medical device trade group, stands solidly behind the substantial equivalence process. Greg Crist, the organization's chief advocacy officer, said it "has served the American public well, facilitating patient access to improved technologies efficiently and with an extraordinary record of safety."

Millions of Americans have found relief from the vast majority of the devices. Studies, Crist said, show that among all kinds of medical devices, less than half a percent of those approved by substantial equivalence have faced a "serious recall."

Some think the FDA has overreacted to the problems with mesh.

A group calling itself Specialists in Urogynecology has started an online petition to protest the sales restriction. More than 6,000 people have signed.

Dr. John Fischer, a uro­gynecology specialist at the University of Minnesota Medical School, said he believes less invasive mesh procedures work well and are better than other options at improving patients' lives.

"It's not the product, but the way it is used," Fischer said.

He does not favor an overall ban on mesh or more severe restrictions. "It would be a shame," Fischer said, "for these procedures to not be available when they have improved the lives of so many women."

Polypropylene mesh for vaginal procedures continues to be a moneymaker. From 2003 to 2018, Securities and Exchange Commission (SEC) filings show that Boston Scientific sold more than $9 billion worth of "pelvic health" products. This included sales of urology and gynecology devices that more than doubled from $226 million in 2003 to $535 million in 2014.

In 2018, the company's pelvic health "franchise" recorded record sales of roughly $1.25 billion, including significant revenue from a line of male products acquired in 2015.

SEC records show that Boston Scientific continued to push sales of vaginal mesh even as the FDA issued its 2011 warning and lawsuits against the company exploded. The number of vaginal mesh patient complaints grew from "more than 250" as of February 2012 to roughly 53,000 as of February 2019, the company told the SEC.

A Boston Scientific spokesman told the Star Tribune in an e-mail that vaginal mesh sales make up only 1% of Boston Scientific's overall sales, which were more than $9.8 billion in 2018. The continuation of vaginal mesh sales was a way to offer treatment options to women, according to the company.

"Clearly this is not about profits," the spokesman said. "It is about doing what is right for patients."

Sheree Kelley wishes that all vaginal mesh products had been tested before they were permanently implanted. The Georgia woman has a Boston Scientific sling inside her that her doctor said would work fine. Despite three surgeries, she lives in near-constant pain.

"I've been told I just have to live with this," Kelley said. "It's like barbed wire in the bark of a pine tree. Mesh is eating me alive."

Jim Spencer • 202-662-7432