Teresa Hughes, 61, a resident of Liverpool, England, and mother of two, has made so much noise about defective vaginal mesh that last year she was profiled in the UK paper, The Daily Mail.
“Thousands of women have been left severely damaged as a result of an implantable ‘sling’ operation to treat problems following childbirth. As a result the NHS is now facing a crisis on a par with the compensation claims for leaking silicone breast implants in the Nineties.”
In the Beginning
Hughes is one of an estimated 64,000 women living in England who is living with the aftereffects of an implantable plastic sling medical device. After undergoing a hysterectomy and experiencing stress incontinence, something she describes as, “nothing really bad,” Hughes says she was offered a transvaginal mesh tape (TVT) as a treatment. The polypropylene plastic mesh is inserted through cuts in the groin area to place the hammock-like support for the urethra to treat the incontinence.
In April of 2006, Hughes had a Boston Scientific Halo Sling implanted.
“They said I was a candidate for this tape for stress incontinence. That was it, nothing else. There was no discussion as to it being made of polypropylene mesh or that it becomes part of you and embeds itself into the body.”
Was she told about the risks?
“There is nothing on my record and they never mentioned that at all,” says Hughes today.
Right after the surgery she began having problems. She says as she came to, she was hurting, especially on the left groin. Crying from the pain for days, the pain would travel to the calf of the left leg. Hughes describes the pain as a “cheese wire” effect because it felt as though she was being stabbed internally.
After being discharged, the pain continued in the left groin along with a cramp in both legs and pain in the calves of both legs which continues today.
Hughes and others have found that no one is monitoring mesh complications either in the U.S. or the U.K. Estimates from studies show complications may run as high as 20 percent in the short run from the mesh disintegrating, migrating, or forming fistulas, to causing a systemic allergic reaction to the polypropylene material. No one has studied the long-term effects.
Hughes returned to her doctor for pain in the groin and leg, then her own general practitioner who gave her quinine tablets. She received a diagnosis of appendicitis, which, it turns out, wasn’t true.
Then in September 2008, Hughes was shown a scan that revealed a mass in the bladder. Her local hospital did a biopsy and in November 2008 she was told she had bladder cancer because something had entwined around her bladder neck. She was asked if her bladder had ever been sewn up? She said she’d had transvaginal mesh tape implanted in 2006 to treat incontinence.
The cancer specialist left the room quickly she says.
It turns out she didn’t have cancer, but it was a foreign body.
Hughes asked the consultant urologist if he would send her for a second opinion; he declined her request.
Hughes asked once again and asked why he wouldn’t help her find another urologist for a second opinion. The consultant urologist replied, “Why should I help you,” she says today. Hughes told him she was in pain and needed help and she told him that she thought it was the transvaginal mesh that was causing her pain in the groin. She asked also to be referred back to the original gynecologist who inserted the mesh sling at the same hospital to have a chat with him about the symptoms she was experiencing. This was declined as well.
So she turned to the internet.
Medical Treatment in England
Hughes receives her medical services under the National Health Service (NHS) of Great Britain. The Medicines and Healthcare products Regulatory Agency (MHRA) is the government agency responsible for ensuring that medicines and medical devices are safe and effective, not unlike the role of the U.S. Food and Drug Administration (FDA).
Under the NHS, the public is not charged for medical services unless they seek out a private consultation. Patients under the NHS have a right to their own medical records for a fee and also the right to a second opinion.
According to Hughes, the latest NHS figures also show the number of affected women is rising by more than 500 a year, indicating that about one in 20 of the 13,500 operations a year to implant the polypropylene material goes disastrously wrong.
Hughes says after the TVT scandal broke a year ago, government regulators agreed to a safety review of the product, but the results have been delayed.
How is Mesh Approved in the UK?
The U.S. Food and Drug Administration’s (FDA) allows most medical devices to enter the market with an assurance the device is the “substantial equivalent” of another similar device already being marketed. With the “substantial equivalence” stamp of approval, a manufacturer does not have to conduct clinical trials. The 510(k) notification process (manufacturers notify the FDA), as it’s called, is an honor system where the public and FDA must trust the ethics of a manufacturer not to put a defective device on the market.
Unfortunately, as the public has discovered from defective metal hip implants, defective silicone breast implants, defibrillator leads, and now transvaginal mesh, that hands-off approach to regulation leaves a huge safety loophole that many trusting patients fall through.
To approve a medical device in Europe, a device manufacturer seeks approval through any one of about 70 decentralized “notified bodies” overseen by for-profit firms. Any one of the bloc’s 27 member nations can approve a medical device for market. (See background story here).
Like the U.S., the EU has a hands-off approval process that failed to detect the Poly Implant Prothese (PIP) breast implants, a major health scandal in Europe as the unsuspecting found their leaking implants were filled with industrial silicone.
Now the EU says it wants tougher rules for the approval and post-approval monitoring of medical devices. After that global embarrassment, last September, the EU health commissioner outlined a draft proposal to identify medical devices that might be considered high risk and put them though greater scrutiny.
The European medical device industry lobby, Eucomed, was unhappy with that proposal.
As is in the case in the U.S., the UK does not follow patients with implanted medical devices after their surgery as part of post-approval monitoring. Nor does it register medical devices so any early signs of failure can be more quickly identified.
It was Australia, which does have a device registry, which was the first country to identify a problem with the Johnson & Johnson’s DePuy ASR metal hip, which was recalled from the market because of an early failure rate.
Meshies United Group – UK
To raise the profile on vaginal mesh injuries, Hughes formed the Meshies United Group – UK ( here), and on January 26, 2012, she delivered a petition to the Prime Minister’s residence at 10 Downing Street to ask for help for the women suffering serious complications following transvaginal mesh surgery.
A meeting followed with her Member of Parliament who asked the government to reveal the number of mesh implant and explant surgeries over the last eight years.
The Medicine Health regulator in the UK did not have the answer.
“I am ashamed to live in a country that cannot keep track of serious complications of a medical device that has been implanted and causing so much havoc and ruining thousands of women’s lives and to be told that the Medicine Health Regulator does not know of the statistics,” the petition says.
Her findings which she received back from her representative in Parliament, suggested there have been nearly 3,000 mesh removal operations within the National Health Service hospitals. They do not include Northern Ireland, Wales, and Scotland, all part of the United Kingdom. Nor do they include statistics on any operations that have taken place in the private health sector.
The Medicine Health Regulator UK showed from 2006-2011, a total of 107 adverse incidents resulting from transvaginal mesh removal complications. No data was collected before the year 2005.
Hughes adds that surgeons are allowed to volunteer an adverse incident or complication event to the MHRA UK. She believes the real numbers are many times larger.
“Many women have lost their jobs their homes and some have lost their husband or partner. Their sex lives have changed forever in fact many women do not have a sex life because of the erosion and damage caused by the mesh.
“Men have also been affected because the mesh has cut their private parts. Some women have died and others wish they were dead because of the amount of pain they are in.
“General Practitioners do not know how to deal with this situation and many women who contact their GP for help are being referred to a mental health team because their lives have fallen apart.
“Would you like to be maimed for life by this barbaric operation? Hughes asks.”
Lawsuits in the UK
In the U.S. most of the more than 10,000 lawsuits filed against nine mesh manufacturers are done so on a contingency arrangement with lawyers. The plaintiff pays nothing unless the lawyer wins her case at trial or she receives a settlement. At that time, she pays a percentage of her award to the law firm that represented her.
In the UK, there is no contingency fee arrangement. In mesh cases, solicitors, as lawyers are called, are asking for money upfront. Hughes says one firm in London, is taking cases but wants £600, close to $1,000 a month to start. Other solicitors turn to conditional fee agreements, where the plaintiff pays nothing if they lose the case but a full fee plus if they win.
“People don’t have that money they lost their job they lost their homes.”
Even with these drawbacks, hundreds of women in the U.K. have come forward to file lawsuits against the four major U.S. manufacturers of synthetic transvaginal mesh.
What incenses her is that doctors still put in vaginal surgical tape every day. She takes calls from women suffering all around the United Kingdom and says doctors are still not telling patients about the serious complications and neither are health regulators.
Hughes has campaigned tirelessly since 2008 to have the Department of Health and the Medicine Health Regulator UK to look into the serious complications of trans-vaginal mesh. On two occasions she demonstrated outside of The Medicine Health Regulator headquarters in London.
At the time she said, “We will no longer suffer in silence anymore. We want answers and we require help and it is about time people sat up and listened to us.”
Hughes is facing more surgery ahead. University College Hospital doctors plan open surgery on her to find the mesh and repair the urethra and bladder neck, but it may take a series of four surgeries. A recent emergency gallbladder removal has delayed her mesh removal surgery.
She has been granted a meeting for November 15, 2012 in Brussels with the Director of Consumer Affairs on behalf of her support group, Meshies United Group UK.
Postscript* Hughes says she is writing a play about the nightmare of mesh. Her brother is a producer in Liverpool.