Health product regulator receives 1,000 complaints over vaginal mesh implants

A regulator has received more than 1,000 complaints about vaginal mesh implants as it emerged hundreds of women are suing manufacturers and the NHS.

Data from the Medicines and Healthcare products Regulatory Agency (MHRA), obtained by the Press Association, shows more than 1,000 adverse incidents related to the mesh implants have been reported in the past five years.

The implants are used to treat pelvic organ prolapse and incontinence after childbirth, but some women have reported severe discomfort and inability to walk or have sex.

The data from the MHRA, from 2012 to this year, shows there were 703 adverse incidents about stress urinary incontinence related to the mesh implants. This means urine leaks out when the bladder is under pressure, such as when coughing or laughing.

A further 346 adverse incidents were for patients with the devices suffering pelvic organ prolapse. The implants are supposed to support organs such as the vagina, uterus, bowel, bladder or urethra that have prolapsed after childbirth.

The MHRA said the figures did not necessarily indicate a fault with any particular device and said individual women may have reported more than one adverse incident.

The data comes after the BBC reported that more than 800 women are suing the NHS or the device manufacturers after experiencing issues.

Almost 9% of users have reported problems, it said, while lawsuits in the US have seen around £2bn paid out to affected women.

The issue reached prominence in Scotland last year after women with painful and debilitating complications formed a support group.

In March, Scottish Health Secretary Shona Robison defended an independent inquiry into the implants, which concluded they should not be offered routinely to women with pelvic organ prolapse.

Three members of the inquiry resigned after patient representatives said critical parts of the report were removed.

Research in December in The Lancet medical journal said using mesh implants to treat pelvic prolapse leads to a higher level of complications than other surgery.

An MHRA spokesman said: "Patient safety is our highest priority and we sympathise with women who have suffered complications after surgery.

"We are committed to help address the serious concerns raised by some patients.

"We have undertaken a great deal of work to continuously assess findings of studies undertaken by the clinical community over many years, as well as considering the feedback from all sources in that time.

"What we have seen, and continue to see, is that evidence supports and the greater proportion of the clinical community and patients support the use of these devices in the UK for treatment of the distressing conditions of incontinence and organ prolapse in appropriate circumstances.

"We encourage anyone who suspects they have had a complication after having a mesh device implanted to discuss this with their clinician and report to us via the Yellow Card scheme regardless of how long ago the implant was inserted."

Patient Kate Langley told the BBC that a surgeon who examined her "could see the [mesh] tape had come through my vagina - protruding through.

"The mesh had cut its way through - like a cheese-wire."

Other women said the perforation was so severe, their partners had been injured by the mesh during sex.

Ms Langley, who described the meshes as "barbaric", said she has had 53 hospital admissions to try to end the pain, but the mesh was so near a nerve, it could not be fully removed.

Claire Cooper had her womb removed at the age of 39 after doctors believed it to be the source of her pain, the BBC reported.

When the pain continued, a GP told her she was imagining it.

She told the BBC she had contemplated suicide, lives in pain and said her husband has "turned into my carer".

She said: "We haven't had sex for four-and-a-half years. This stuff breaks up marriages.

"I want the procedure banned. I want the material banned."

From April 2007 to March 2015, more than 92,000 women had vaginal mesh implants in England, according to NHS data obtained by the BBC.

The UK legal action is against the NHS and manufacturers, including US pharmaceutical giant Johnson & Johnson, the biggest makers of mesh implants.

Its subsidiary, Ethicon, told the BBC it was "vigorously defending litigation".

A statement from Ethicon said: "Patient safety is our first priority.

"We empathise with all women suffering from pelvic organ prolapse and stress urinary incontinence, and are always concerned when a patient experiences an adverse medical event.

"TVT, TVT-O and Prolift were developed by surgeons seeking to address the shortcomings of other treatment options for stress urinary incontinence and pelvic organ prolapse.

"As other devices emerged, Ethicon continued to work in conjunction with doctors to provide them with additional options.

"These devices have helped millions of women suffering from stress urinary incontinence and pelvic organ prolapse.

"The success experienced by the vast majority of women who have been helped by these devices mirrors the scientific data and demonstrates that the devices should remain available as options for women, and their healthcare providers, who could benefit from their use in the future."

There are around 100 types of vaginal mesh implants, but no mode has been recalled in the UK.

Professor Carl Heneghan told the BBC that manufacturers have to provide little evidence before their product is clinically approved and made available on the NHS.

"The regulatory body... doesn't even look at the device," he said.