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Ethicon Media Monitoring 4/26/2017
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Australia's peak health regulator has not pursued one pelvic mesh prosecution
Apr 26, 2017 | Newcastle Herald
By Joanne McCarthy
AUSTRALIA’S peak health regulator has not pursued the prosecution of a single pelvic mesh manufacturer for failing to report serious injuries to women despite at least 1000 known serious injury cases linked to mesh, criminal sanctions if a manufacturer fails to report, and a 2013 report acknowledging the regulator “only receives 10-20 per cent” of all adverse events. -
Pelvic floor training in pregnancy could help prevent the need for 'barbaric' vaginal mesh surgery
Apr 25, 2017 | Medical Xpress
By Victoria Salmon And Rachel Jarvie
For millions of women, childbirth is a somewhat daunting yet thoroughly rewarding process. In the western world, many years of medical research and professional experience mean that women have access to expert care before, during and after birth.
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Australia's peak health regulator has not pursued one pelvic mesh prosecution
Apr 26, 2017 | Newcastle Herald
By Joanne McCarthy
AUSTRALIA’S peak health regulator has not pursued the prosecution of a single pelvic mesh manufacturer for failing to report serious injuries to women despite at least 1000 known serious injury cases linked to mesh, criminal sanctions if a manufacturer fails to report, and a 2013 report acknowledging the regulator “only receives 10-20 per cent” of all adverse events.
The Therapeutic Goods Administration (TGA) has outraged Australian Pelvic Mesh Support Group founder Caz Chisholm and mesh victim Gai Thompson after urging women and doctors to report serious injuries, and advising the Newcastle Herald it “did not receive any material evidence to enable investigation of a manufacturer”.
This is despite advice from a specialists’ working group to the TGA in 2013 that while “the reporting of adverse events is mandated for manufacturers”, there was “awareness that company representatives aren’t reporting all complications to the TGA”.
Under the Therapeutic Goods Act it is a criminal offence for a manufacturer not to report to the TGA within 30 working days of becoming aware of an adverse event, with penalties of up to 12 months’ jail and fines of up to $180,000. Manufacturers are the only mandatory reporters of medical device adverse events under current legislation.
“Women have reported their injuries and the TGA has done nothing, and now they’re putting responsibility for their failure to act back onto the injured patients,” Ms Chisholm said.
“I think it’s disgusting what they’ve said because they’re responsible for allowing these devices to be used, they’re responsible for not acting when women reported their injuries, and they’re responsible for not prosecuting these manufacturers who are the only ones with a mandatory responsibility to report adverse events.
“They’re leaving it up to women to sue the manufacturers directly, and they’ve done nothing.”
I think it’s disgusting what they’ve said because they’re responsible for allowing these devices to be used, they’re responsible for not acting when women reported their injuries, and they’re responsible for not prosecuting these manufacturers who are the only ones with a mandatory responsibility to report adverse events.- Australian Pelvic Mesh Support Group founder Caz Chisholm
The TGA confirmed “there have been no criminal or civil penalty proceedings against any transvaginal mesh manufacturers for failing to report an adverse event” in response to Herald questions about what action the TGA took after a 2013 report raised serious questions about the failure of the medical device complaints process to respond quickly, despite warnings about transvaginal mesh devices from as early as 2003.
The devices are used to treat prolapse complications after pregnancy and birth with surgery through the vagina rather than the abdomen.
The August, 2013 urogynaecological devices working group report, released after a freedom of information application, noted that by 2008 the TGA knew that symptoms linked to transvaginal mesh surgery, including erosion of mesh into the vagina or rectum, were “common adverse events with these types of devices”.
The TGA acknowledged the number of device incident reports on transvaginal mesh was “small, considering the number of mesh devices supplied to the Australian market”, while the “potential adverse effects of surgery and mesh exposure on the bowel, bladder and sexual function are considerable and serious”.
“It was noted that there was recognition of significant under-reporting (of adverse events) for all products, with the TGA estimating it only receives 10-20 per cent of all events,” the working group noted.
The working group of specialists advised the TGA that “surgeons do not have a strong awareness of Australia’s adverse event reporting systems”.
In response to questions from the Herald the TGA said it was the Office of the Commonwealth Director of Public Prosecutions’ responsibility to prosecute alleged criminal offences against Commonwealth law.
“In the case of transvaginal meshes, the TGA did not receive any material evidence to enable investigation of a manufacturer for not providing the TGA with the required adverse events data. The TGA needs to have in its possession sufficient facts and evidence behind an allegation to enable an investigation to commence,” the TGA said.
The response outraged Gai Thompson, whose complaint in writing to the TGA in October, 2011 about serious and permanent complications following mesh surgery in 2008 that made her life “a living nightmare”, was not responded to until October, 2014, when the TGA advised “an investigation into the incident you reported… is now complete”.
The TGA thanked Mrs Thompson for her “support of the Medical Device Incident Report Investigation Scheme”, and noted her incident summary would be included on the TGA’s database.
“I wrote to them. I made so many phone calls to them and they were so rude and so dismissive of what I was saying. They don’t care,” Mrs Thompson said.
“They’re supposed to be the regulator. They’re supposed to be the ones protecting the public but they’ve done nothing, and now they’re trying to say we should have reported. We did report, but it’s not up to us. Why is it up to the women who are the victims of this whole thing to be the watchdog as well?”
Mrs Thompson said she was aware of the TGA and the adverse event reporting system because of a previous medical incident involving her mother.
“How on earth are average members of the public supposed to know about a system that relies on the victims to report when things go wrong?” she said.
Ms Chisholm said she hoped a Senate inquiry on transvaginal mesh that is taking submissions until May 31, and expected to hold public hearings across the country by mid-year, includes questions about the adverse report system that leads to change.
“The manufacturers and the doctors have vested interests in mesh surgery so they’re not going to report adverse events, and so it’s left up to the women,” Ms Chisholm said.
http://www.theherald.com.au/story/4619798/outrage-over-mesh-prosecution-failure/
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Pelvic floor training in pregnancy could help prevent the need for 'barbaric' vaginal mesh surgery
Apr 25, 2017 | Medical Xpress
By Victoria Salmon And Rachel Jarvie
For millions of women, childbirth is a somewhat daunting yet thoroughly rewarding process. In the western world, many years of medical research and professional experience mean that women have access to expert care before, during and after birth. However, there is still one matter that is not being addressed enough during pregnancy: pelvic floor health. Women often do not realise, and are not properly informed, that something can be done to reduce the risks of pelvic floor problems in pregnancy and after childbirth.
The pelvic floor muscles lie across the base of the pelvis, supporting and holding the bladder, uterus and bowel in position. They also help to control the bladder and bowel. Pregnancy and childbirth can cause problems such as weakness, overstretching and tears in the pelvic floor muscle, due to increased pressure.
Weakening or damage may result in inability to control bladder or bowel movements, resulting in incontinence. Muscle weakness can also contribute to pelvic organ prolapse, which is the bulging of one or more of the pelvic organs, such as the uterus, bowel and bladder, into the vagina.
Urinary incontinence is a common problem, affecting over 5m women in the UK alone. Between 30-50% of women will experience some leaking of urine during or after pregnancy. And, according to one study, up to three out of four women still experience symptoms 12 years after giving birth.
Incontinence can make women feel shame and embarrassment, which stops them from seeking help. It is normalised in UK society, with many women believing that incontinence is an unavoidable consequence of having children, further stopping them from accessing treatment. They are exposed to media images of female incontinence as normal and inevitable: young women are portrayed as accepting the condition in adverts for absorbent products, accompanied by tag lines such as "Oops moments happen. C'est la vie."
Prevention rather than treatment
When women do seek help for pelvic floor problems they are offered treatment according to the severity of their symptoms. Pelvic floor muscle training (PFMT) is a first line treatment. PFMT involves pulling up the pelvic floor muscles by pretending to hold in wee or stopping passing wind. The muscles can be strengthened by regularly doing a series of long and short holds. For example, squeezing these muscles slowly ten times in a row, then doing ten fast squeezes and repeating this three times per day.
In more severe cases, surgery may be offered, which can include insertion of mesh through the vagina, to provide extra support when repairing weakened or damaged tissue.
However, vaginal mesh surgery has more problems than benefits. It has been called "barbaric" and recently led to more than 800 women suing the NHS over complications with it such as permanent pain, and an inability to walk, work or have sex.
So why aren't we focusing more on women's pelvic floor health in pregnancy, to try to avoid these conditions developing?
Evidence shows that PFMT can help prevent and treat incontinence in pregnant women or women who have recently given birth. In fact, research has found that women having their first baby who performed PFMT were about 30% less likely to experience incontinence up to six months after delivery. There is also increasing evidence that PFMT may prevent symptoms of pelvic organ prolapse and could reduce the uptake of further treatment.
UK guidelines for antenatal care recommend midwives offer information about pelvic floor exercises at a pregnant woman's first appointment. However, for PFMT to be effective it needs to be delivered through a structured, supervised training programme. Simply giving out information on its own is rarely enough to support people to carry on exercising long term.
Women have reported that the information they received about PFMT in pregnancy was insufficient, and they weren't told about the importance of pelvic floor health. They did not understand why they had to do the exercises or how to do them correctly. The information was not clearly linked to the role of the muscles in reducing the risk of incontinence or pelvic organ prolapse so many women did not think PFMT was worth doing.
Evidently, more could and should be done to improve the quality and delivery of PFMT information during the antenatal period. Incontinence and prolapse do not need to be taboo, but nor should they be normalised as part of the consequences of childbirth and pregnancy.
PFMT during pregnancy presents an opportunity to prevent long-term, debilitating pelvic health problems and may reduce the need for further medical or surgical intervention. But for this to happen, women need to understand the benefits, know how to do it and feel that PFMT is realistic and doable in their daily lives.
https://medicalxpress.com/news/2017-04-pelvic-floor-pregnancy-barbaric-vaginal.html
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