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Ethicon Media Monitoring 8/13/2018
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Memos reveal mesh firms were warned 21 years ago that material should not be used on humans
Aug 12, 2018 | The Sunday Post
By Marion Scott
Medical manufacturers were warned decades ago that plastic should not be used to make mesh implants, according to court papers. -
‘The Bleeding Edge’ Offers A Sobering Look At What Motivates The FDA
Aug 10, 2018 | Study Breaks
By Christian Cannon
The Bleeding Edge” lifts the veil. It’s an intense drama detailing the struggles of patients who have been harmed by medical devices, but it also exposes the real culprit of their pain: corruption in the FDA and corporate greed. -
The men left in agony after being given implants to repair a hernia
Aug 12, 2018 | Infosurhoy
By Marta Subat
Mario Spacagna is eternally grateful for the surgery that removed his kidney tumour. -
Australian women to launch class action over failed Essure contraceptive device
Aug 13, 2018 | ABC.au
By Alison Branley and Sophie Scott
Mother-of-four Tanya Davidson struggled daily with pain from the contraceptive implants wreaking havoc in her body, but it was years before she discovered the pain was being triggered by a major allergic reaction.
Client Attorney Privileged/Attorney Work Product/At Request of Counsel
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Memos reveal mesh firms were warned 21 years ago that material should not be used on humans
Aug 12, 2018 | The Sunday Post
By Marion Scott
Medical manufacturers were warned decades ago that plastic should not be used to make mesh implants, according to court papers.
The multinationals are accused of ignoring a series of warnings to continue using the plastic mesh in operations that have left hundreds of thousands of women around the world with life-changing injuries.
Campaigners in Scotland yesterday called for the firms, who supplied the NHS with mesh devices, to face criminal investigation.
Around 1800 Scottish women a year were given mesh implants for bladder problems and pelvic organ prolapse in the two decades before its use was suspended in 2014.
But, according to courtroom evidence in America, one of the world’s biggest hernia patch and mesh implant manufacturers, CR Bard and subsidiary Davol were told they should not continue using polypropylene resin in surgical implants as far back as 1997.
The supplier of the resin called Marlex told them repeatedly that they feared being sued if the product was used in implants.
During evidence in a New Jersey Supreme Court case, former CR Bard vice president Roger Darois admitted receiving a call from Texas-based petro-chemical giant Chevron Phillips, which made Marlex, and told the court: “They were concerned about litigation and the association with the Marlex name with a permanent medical implant.”
Seven years later, in January 2004, Chevron Phillips lodged formal warning notices that Marlex was “not for human implantation” and told medical mesh firms they did not want their custom “at any price”.
But Bard and other mesh manufacturers continued using the polypropylene resin in products, including millions of hernia patches as well as implants for bladder problems and pelvic organ prolapse after identifying alternative suppliers, who, according to memos, were not told it was to be used in medical implants. The NHS in Scotland were among their customers.
Mr Darois admitted at a court hearing in April that Marlex continued to be used in millions of hernia mesh patches as the firm bought the product through third parties.
One 2004 email from Mr Darois states: “These suppliers will likely not be interested in a medical application due to product liability concerns.
“We purchase our polypropylene monofilament from an extrusion supplier who purchases the resin directly from the resin manufacturers.
“Thus, it is likely that they do not know of our implant application. Please do NOT mention Davol’s name in any discussions with these manufacturers.
“In fact, I would advise purchasing the resign through a third party, not the resin supplier, to avoid a supply issue once the medical application is discovered.”
He told the court: “I was trying to make sure we didn’t have an interruption of supply for the resin we relied on for all those products.”
He said a million of their hernia patches were used every year in the US, and it would have been “irresponsible” to compromise that.
Hernia patients have reported horrific internal injuries, including Michele McDougall, 55, from Edinburgh, who died in May after suffering years of painful internal injury and chronic infections from six mesh patches.
She was too ill for chemotherapy to treat vaginal cancer so rare only three other cases have been recorded.
Another medical manufacturer, Boston Scientific, which allegedly bought counterfeit Marlex plastic from China when suppliers refused to continue dealing with them, says it has complied with regulators.
A spokeswoman said: “While the manufacturer (Chevron Phillips) did create a medical application statement to add to its medical safety data sheet (MSDS) for the resin that we use, and that statement purported to warn against using the resin for certain medical applications, they did so only to avoid potential legal liability because they had not performed medical safety testing.”
The firm claimed Chevron had no “scientific literature” or “testing” to support their 2004 statement, and it continued supplying Boston Scientific until 2011 when it was “unable to procure an additional supply directly from the manufacturer”.
In 2015, a US court awarded Deborah Barba, 51, from Delaware, £75million, most of which was punitive damages, against Boston Scientific.
The award was capped under court rules.
Boston Scientific’s mesh devices Advantage Fit and Pinnacle were regularly supplied and used by 11 health boards in Scotland, including Glasgow, Edinburgh, Tayside, Fife, Lanarkshire and Forth Valley.
Chevron Phillips refused to discuss their warnings due to “matters in litigation”.
Claire Daisley, 48, from Greenock, who has been left crippled by mesh surgery and is now waiting to have both her bladder and bowel removed, joined calls for manufacturers to face criminal prosecution for what victims have called “the biggest medical scandal of modern times”.
Leading mesh lawyer Adam Slater, who gave evidence about mesh to MSPs at Holyrood, said: “There is a concept in the law of criminal recklessness.
“In my opinion, the mesh manufacturers were criminally reckless, and more.
“They knew women would be severely hurt but hid this knowledge so they could profit.”
MSP Neil Findlay said: “Here we have yet more evidence of the outrageous lengths mesh companies will go to maximise their profits all at the expense of lives and well-being.
“What more evidence is needed to take forward a prosecution?”
https://www.sundaypost.com/fp/memos-reveal-mesh-firms-were-warned-21-years-ago-that-material-should-not-be-used-on-humans/
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‘The Bleeding Edge’ Offers A Sobering Look At What Motivates The FDA
Aug 10, 2018 | Study Breaks
By Christian Cannon
The Bleeding Edge” lifts the veil. It’s an intense drama detailing the struggles of patients who have been harmed by medical devices, but it also exposes the real culprit of their pain: corruption in the FDA and corporate greed.
The most extensive coverage included in the film is of Essure, a permanent birth control method that caused an uproar around the world. Essure, a small metal implant, was designed to be inserted into the fallopian tubes and agitate their lining. This would then cause scarring around the implant and serve just as tubal ligation would.
It’s a great concept, but many women’s bodies rejected the implant, sending it to their uterus. Others bled excessively, one of whom is featured in the film and says when she reported this to her doctor, he suggested her bleeding was because she was Latina.
When surgeons attempted to remove the implants, they often broke, spreading fragments and leading to even more removal surgeries. As appalling as this is, and as much as it might make “The Bleeding Edge” seem like a fearmongering anti-birth control movie, such stories are just part of a much larger picture.
The background of that picture, if you will, is an FDA-approval process called the 510(k). It was passed originally as a revision to the FDA’s primary approval process, which required clinical trials, but has now become the norm by which 98 percent of devices are introduced to the market.
Under the 510(k), the only requirement is that a product must be “substantially equivalent” to one that has been approved in the past. This means products can be approved based on the approval of other products that are themselves only approved on the clearing of even older products.
What’s more, even if a device that is used to grant the approval of others is recalled, the others can legally remain on the market. With the exception of Essure, all of the devices featured in the film were approved through the 510(k).
Overuse of the 510(k) explains why often the first people to discover side effects are patients. Not only are they left to discover them, but they also carry the burden of reporting them.
Dr. Adriane Fugh-Berman, a professor of pharmacology and physiology at Georgetown University, appears on “The Bleeding Edge” with a study that found the worse the outcomes are, the less likely they are to be reported. Only an estimated 3 – 4 percent of total complications following device implants are reported at all, mainly because the system relies on self-reporting.
“The Bleeding Edge” represents beating the odds, and is mostly told by patients who did much more than self-report their symptoms. Months after having a cobalt hip replacement, one patient, who is ironically a doctor also, linked his intensifying mental hiccups to his recent surgery.
Parts of the cobalt had dissolved into his bloodstream and begun to poison him. Using his own medical expertise, he conducted studies using data from other cobalt joint replacement patients who shared symptoms, and he now lectures on his results across the country.
The movement against Essure began as just a Facebook group, “Essure Problems,” where women connected over similar experiences. Eventually, the group became an organization and movement with over 40,000 members worldwide. Their pressure on the EU led Bayer to take Essure off the market in Europe.
In the early stages of the group’s development, they pooled money to obtain a video of the FDA-approval meeting where researchers presented their clinical trials. The video is included in the documentary, showing questions being glossed over – questions like “What happens if the patient is allergic to the metal in the implant?”
A lead investigator is also shown on video saying he “received compensation,” which “represented a financial interest in the company.” Even though the film may seem overly dramatic in parts — mainly because of the music — the evidence for negligence and conflict of interest is impartial and honest, and is often shown through a primary source, like the footage from the FDA meeting.
It also seems to focus too much on Essure and not enough on some of the other medical devices. There’s a trade-off though: weeks before the documentary was released, Bayer announced it would take Essure off the market in the U.S. by December. Had the directors covered other stories more, it might have had less of an impact on Bayer.
The movement against Essure appears to be the only backbone of the film. However, without the substance of that movement — the history, the size of it, the progress — there might not have been a platform to give the other stories with less substance. Some of the most shocking parts of the film lasted only five or six minutes.
A great example of this is the brief section on the CT scanner. Dr. Julian Nicholas, a scientist at the FDA from 2006 – 2009, received an application for its approval. He knew that overuse of the scanner could cause cancer, so he and nine other scientists proposed a warning label be required to be placed on the machine before it could be sold to hospitals.
They received massive pushback and the scientists were “fired or let go” within two years of trying to push through their proposal. Also, a U.S. Congress joint staff report in 2014 found that Dr. Jeffrey Shuren, the director of the FDA at that time, had installed Spector software on the whistleblowers’ computers.
Another example has to do with the da Vinci robot. Made by Intuitive Surgical, the da Vinci is designed to perform minimally invasive surgeries. Its controller measures the surgeon’s hand movements with sophistication, and it’s recommended for operations like hysterectomies. The problem with it is training.
When the da Vinci robot was submitted to the FDA to be approved, Intuitive Surgical required hospitals sign surgeons up for nine weeks of training along with their purchase of the system. Weeks before its clearance, they dropped that requirement. A current da Vinci cardiac surgeon appears on the film saying he “didn’t really start to feel comfortable until about 200 or 300 cases in,” and that he was told he would need about 10 cases to become “good.”
What type of surgery he’s talking about exactly is unknown, and he might just be a slow learner, but the complications related to da Vinci surgeries could be prevented if training was standardized. As of now, it varies from hospital to hospital.
These issues may seem far away or overshadowed by the other domestic health problems like the opioid crisis or conspiracies against “big pharma.” When I first watched the film, it seemed overly dramatic as well, but the facts stood out. I shared it with my family and realized corruption in the medical device industry isn’t far from my life at all, even though I thought it was.
Apparently, my cousin who worked at a law firm had a number of cases related to the Prolift, one of the implants featured in “The Bleeding Edge.” The Prolift, made by Johnson and Johnson’s company Ethicon, is a pelvic mesh made from material previously used to close hernias. It is designed to assist deteriorated tissue around women’s reproductive organs.
While it can be supportive, it can cause scar tissue buildup and become fixed in problematic positions for women, making it hard to walk comfortably and without pain. Removal also leads to surgery after surgery — I personally know someone who had to endure over five of these surgeries, managing to only get pieces out each time. Her recoveries were brutal.
The last example is simple but telling: The surgeon who performed my mom’s partial knee replacement was part of the team of scientists who designed the replacement part itself. Within a year of the surgery, doctors confirmed that the problem with my mom’s knee was no longer mechanical — over seven surgeries throughout the last two decades had apparently taken care of that.
They said the pain was related to her nervous system, and that the knee replacement was not going to help as they expected. It seemed like their diagnosis suddenly became more accurate after the surgery was paid for.
One day most of us will be patients. We can all benefit from the innovations of the medical device industry, and we can all be harmed by negligence in their testing stages. The change the world will need in the future is risky and should stretch the boundaries of what’s safe, but we need to make sure people are informed of the risks.
https://studybreaks.com/tvfilm/bleeding-edge-look-at-fda/
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The men left in agony after being given implants to repair a hernia
Aug 12, 2018 | Infosurhoy
By Marta Subat
Mario Spacagna is eternally grateful for the surgery that removed his kidney tumour.
But he fears he will pay the physical costs of his survival for the rest of his life as a result of a secondary operation following the successful cancer surgery.
‘I am in constant pain, day and night,’ explains the 75-year-old from Southampton. ‘I can be walking down the street and my legs will suddenly fold up under me. I can’t breathe and I can’t speak.
‘Sometimes it is a general ache and other times it is a sharp stabbing sensation like having a knife stuck in my side. Anyone who saw me would think I was having a heart attack.’
Mario has had a large, ten-inch square sheet of plastic surgical mesh placed internally to repair damage caused by the partial removal, in October 2013, of one of his kidneys which was affected by a large cancerous tumour.
‘I was left with a bulge in my side where the kidney surgery had left a gap in the muscles holding everything together,’ he says. ‘It was about half the size of a football after the operation. A small mesh was put in to hold everything in place. It didn’t work so in October 2015 they went back. They couldn’t take out the original mesh so they put another huge piece of mesh over the top. It didn’t work either.’
Quite apart from the ongoing pain, he says he still has ‘this huge bulge — clothes don’t fit me properly and I’m very self-conscious about it’.
‘The doctors say they can’t take the mesh out because the flesh will have grown into it. It has very sharp edges which dig in all the time and sometimes touch nerves. The pain is gradually getting worse and there is apparently nothing they can do about it.’
There are dozens of different types of plastic mesh in use for surgical repairs, most made from a type of material called polypropylene — which is also used for ropes.
It causes an inflammatory reaction but in most people, this settles down. However, some have experienced other problems, as the mesh moves or migrates, or its sharp edges cause continuing pain.
If it is near the vagina or bowel, where there are naturally high levels of bacteria, experts say it can set up an infection which may degrade the material causing it to break up into fragments, burrowing into tissue.
This is what has happened to countless women, who have undergone surgery using a form of surgical mesh (also known as tension-free vaginal tape or TVT) to treat incontinence, typically as a result of damage post childbirth. For over ten years they have been reporting injuries caused by the material, with some left unable to walk and reliant on wheelchairs because of nerve damage. Last December Chrissy Brajcic, a 42- year-old Canadian woman died after developing multi-drug-resistant infections following pelvic mesh surgery, and then sepsis.
Following a long running Good Health campaign, the use of mesh to treat incontinence has now been suspended pending a government review led by Baroness Julia Cumberlege into its safety.
And under new clinical guidelines, any surgeon wanting to use it will be expected to show ‘documented evidence’ they have additional training and experience to ensure they have specialist skills in the use of the material.
The guidelines also require hospital trust medical directors to ensure procedures are in place to, ‘support patients who have had previous mesh surgery who may have concerns’.
The guidelines cover the use of mesh for urinary incontinence in both men and women but the review and guidelines will not help others such as Mario or others like him given the mesh for hernia or bowel repairs where it has gone wrong.
Kath Sansom who runs the patients’ pressure group Sling the Mesh which is campaigning for a complete ban on mesh says her 6,400 members now include more than 300 men.
They have either suffered damage from use of mesh for hernia repairs — where part of the digestive tract protrudes through a weak point of the stomach muscle wall — or have been left with injuries following the use of mesh for bowel repair.
Kath Sansom says her investigations have revealed seven mesh-associated deaths have been reported to the Medicines and Healthcare products Regulatory Agency (MHRA) — the MHRA says its investigations showed none of the deaths was related to use of the material.
Mesh is routinely used in thousands of hernia repairs on men every year and while many have benefited, some report it’s caused them serious and ongoing problems — and in Good Health’s investigations into the use of mesh, patients have told us they were never warned there was a risk the material might move around or even break up into fragments.
‘We appreciate there may be no other solution for hernia than to use a mesh, but not all mesh material is the same and none of the people who have contacted us say they were warned of the risks,’ Kath Sansom told Good Health.
‘We also think that some types of mesh material are totally inappropriate for use in the human body.
‘A lot of the time mesh has been used because it is cheaper and requires less skill than doing a repair using a patient’s own tissue. It is a bit like using stick on patches to repair clothes. There will now be a problem with surgeons no longer having the necessary skills to do complex stitched repairs.’
Austin Obichere, a specialist colorectal surgeon at University College Hospital, London, who operates on men damaged by mesh used for hernia or bowel repairs says their problems are unlikely to be as severe as those experienced by women because the stomach wall has fewer bacteria than the genital tract, bladder or bowel, and is a better environment for the mesh to work.
But he adds: ‘Four to six per cent of [male]hernia patients may suffer serious pain which can mostly be sorted out. They should always be warned of the risk of problems before the operation.’
Hernia patient Keith Devine insists he was never told there was a chance of the mesh triggering a reaction. Keith, 56, from Weston-super-Mare in Somerset, had to give up his job as a senior Whitehall civil servant after having a hernia operation in November 2016.
He’d paid £1,400 to have it done privately at a London hospital to avoid joining an NHS queue.
‘My GP had told me I needed a hernia repair, it was a completely routine procedure but I would have to wait 15 months to get it on the NHS,’ recalls Keith, who is separated from his partner and has two young step-daughters.
‘I had always been fit and healthy and a keen tennis and squash player. I was actually teaching squash at a local club the day before the operation. I was keen to get it out of the way and get back to work.
‘That hasn’t happened. I had diarrhoea, sickness and pain immediately after the surgery and the pain was so bad I couldn’t walk at all for about three months.
‘I still struggle to walk upstairs, I can’t work or travel far. I wake up every night as the painkillers wear off and it’s also made me impotent. It’s basically ruined my life.
‘I had no idea there was such an epidemic of problems with this stuff and I wasn’t told of the risk.’
Keith has taken legal advice and complained to the General Medical Council about the intractable pain caused by what he believes was substandard treatment.
Ian Waterfield, 56, a former chef from Huddersfield, is also taking legal action, following bowel repair with mesh.
He is one of around 100 patients who say they suffered after surgery performed by surgeon Anthony Dixon who worked at Southmead Hospital in Bristol as well as privately. (Mr Dixon has now had restrictions placed on him by the General Medical Council, preventing him from carrying out bowel repair surgery pending an inquiry.)
Ian was referred to Mr Dixon through the NHS and underwent the mesh repair operation in 2010 but has since had to undergo repeated operations and the removal of a section of his bowel. ‘I am in constant pain — it’s like bits of broken glass sticking into me,’ he says.
Like the hernia patients, those who’ve experienced problems with mesh for bowel problems are not part of Baroness Cumberlege’s independent medicines and medical devices safety review.
Surgeons point out there is no alternative to mesh for many patients, whether it’s for hernia, bowel problems or incontinence.
Arjun Shankar, a specialist in complex hernia repairs at University College Hospital, London, said surgery to the abdominal organs causes a hernia in one in four cases. ‘Mesh is the only treatment,’ he said. ‘Clearly there was a problem using one type of this material in women because it sticks to the tissue.
‘We use a mesh that is coated with a non-stick chemical, but even so there are problems with pain in a small percentage of patients. Some of them can be treated by ablation [cauterization]of affected nerves.’
Marcus Drake, a professor of urology at Bristol University, also defended the procedure. ‘I have myself had a hernia repair about 15 years ago using this mesh and I have never had any problems,’ he says.
‘There are two possibilities to explain why things might go wrong. Firstly poor surgical technique or a failure to appreciate the implication of inserting the material into poor quality tissues which means a greater risk of infection.’
He adds that obesity — an increasingly common problem — slows healing and increases infection risk.
And in women, menopausal thinning of vaginal tissues causes similar complications.
‘Used correctly mesh is infinitely superior to the old operation of colposuspension [a stitched procedure using the patient’s own tissues to hold the bladder up]which involves a deep six or seven inch cut through the muscles you use to sit up. It leaves patients absolutely physically hammered and there is a very long recovery. Being unable to exercise for three months, in a middle-aged woman is not good.’
Professor Drake is part of a study team comparing results in 180 men who have undergone mesh repair for urinary incontinence with another 180 who have had an artificial valve inserted to control the leaking. He agrees the material should not be used pending the results of this study which are not due until 2020.
Meanwhile Mario, a divorced former dockworker, who has three sons and three grandchildren but lives alone, says he’s been given no advice or support on dealing with his crippling pain.
Instead, in a story tellingly similar to the ones told by women for years when they tried to report their problems with TVT, he says: ‘I have mentioned the pain every time I have been for my six monthly cancer check ups but they said there is nothing they can do. I was told in March this year I don’t need any more cancer checks, and that the pain from the mesh is a small price to pay to have my life saved. I’m conscious that at my age they are not going to push more treatment at me, but I wasn’t told about the side-effects of this mesh. Something like that is bound to have sharp edges, but it was just never mentioned.’
Southampton General Hospital where Mario’s treatment was carried out said the hospital would be happy to discuss his issues via their patient support service.
In a statement to Sling the Mesh about the deaths, the MHRA said patient safety is its highest priority but added: ‘We recognise some women do develop serious complications. We also know many women gain benefit from these surgical procedures for what can be extremely debilitating conditions. The decision to use mesh should be made between a patient and clinician, recognising the benefits and risks in the context of the distressing conditions being treated.
‘We continue to work closely with NHS England, NICE and professional bodies, and we are all committed to helping address the serious concerns raised by women who have experienced complications.’
Mr Dixon has declined to comment about the complaints citing patient confidentiality. North Bristol NHS Trust, which operates Southmead Hospital, has said: ‘We would like to reassure patients that we are taking this very seriously and our investigations are continuing. It would be inappropriate for us to comment on specific details while our investigations are ongoing.’
http://infosurhoy.com/cocoon/saii/xhtml/en_GB/science/the-men-left-in-agony-after-being-given-implants-to-repair-a-hernia/
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Australian women to launch class action over failed Essure contraceptive device
Aug 13, 2018 | ABC.au
By Alison Branley and Sophie Scott
Mother-of-four Tanya Davidson struggled daily with pain from the contraceptive implants wreaking havoc in her body, but it was years before she discovered the pain was being triggered by a major allergic reaction.
The culprit was nickel and it was being exposed by the corrosion of an Essure device doctors had assured her was "safe and effective".
Essure is a permanent contraceptive system that involves two metal coils inserted in a woman's fallopian tubes.
The coils stimulate scarring, which permanently blocks the tubes and prevents an ova and sperm meeting.
Ms Davidson had the metal coils implanted in 2010 as a way to avoid surgery associated with a traditional tubal ligation.
"When I saw the Essure brochure it was saying that it's a gentler approach, and the big fact for me with it was it was non-surgical," she said.
"When you've got four little ones crawling around you can't afford to have the time off."
But within days of the procedure Ms Davidson said she experienced heavy bleeding. Within weeks she had severe pelvic pain and hair loss.
A doctor recommended a second intra-uterine device called a Mirena to control bleeding.
Ms Davidson later learned this caused the two metal devices inside her to react and spark off each other.
When she insisted her gynaecologist remove the Mirena, the doctor controlled the bleeding using a method called ablation.
This heated up the metal in her Essure and the device broke down further inside her.
All the while her gynaecologist kept assuring her the Esssure device was completely safe and many of her symptoms were psychological.
"He said he would be happy to insert the coils in to any of his female relatives," she said. "I was seeing red. I couldn't believe it."
Eventually a second specialist took one look at the rash on Ms Davidson's face and diagnosed a nickel allergy from the coils corroding insider her.
Nickel allergies are common and it is estimated up to 17 per cent of women and 3 per cent of men are allergic to the metal.
He tried to remove Ms Davidson's fallopian tubes all together, and Ms Davidson, having discovered more about Essure's effects, advised not to pull at the coil because it was known to break up.
But the surgeon did pull at the device and it broke, leaving shards of nickel and plastic insider her abdomen. She had to have a full hysterectomy.
While those shards linger in her abdomen, the immune symptoms associated with a severe nickel allergy from the device still remain.
"I want someone to be accountable to for doing this," she said. "Not just to me but to my kids, they've lost their mum, my partner lost his wife."At least 3,000 Australian women affected
Ms Davidson is one of dozens of women who have signed up to be part of class action against international pharmaceutical giant Bayer, the makers of Essure.
The action is being brought by law firm Slater and Gordon and will mirror other class actions in countries like the United States, Canada and Scotland.
While there are no official figures on the number of Australian women with an Essure, rough estimates suggest between 3,000 and 5,000 women across the country have the permanent contraceptive device.
Bayer recalled the product from market last year after the regulator, the Therapeutic Goods Administration (TGA), issued a hazard alert.
Investigating solicitor Ebony Birchall said the firm had been contacted by dozens of women with concerns, and expected there may be hundreds more who have experienced problems.
She said the main problems with the device had been corrosion of the stainless steel exterior, which exposes women to the nickel inside, perforation of the uterus, and dislocation of the device into the uterus or abdomen.
"A lot of the women I have spoken to have had to have a hysterectomy to try and overcome some of these symptoms.
"Then there's also been issues like auto immune diseases that are possibly related to things like chronic fatigue."
Dr Bernadette White from the Royal Australian and New Zealand College of Obstetricians and Gynaecologists (RANZCOG) said there was anecdotal evidence that Essure was linked to pelvic pain.
But she is sceptical that the device could have caused problems such as auto-immune diseases.
"It's more difficult to see how you would link the Essure device with some symptoms that women have linked to it," she said.
Ms Birchall said they hoped the legal case would force Bayer to answer questions about the device.
"The medical experts that we've spoken to have indicated to us that the risk of the eventual corrosion of the device should have been foreseeable," she said.
In a statement, a Bayer spokeswoman said Essure was placed on the market after going through TGA approval processes.
"While it was on the market Essure was maintained and updated in accordance with all health authority requirements to ensure the label reflected all current safety information," the statement said.
Ms Birchall said women had lost partners, jobs and their ability to care for their children.
"A lot of the women have said things to me like, 'I wasn't informed of any of these risks'. So something that was at first a safe, quick, efficient fix, has turned into something that has completely turned their lives upside down."
A Bayer spokeswoman said it discontinued Essure in Australia in 2017 "due to a low and declining trend in patient preference".
"We are always saddened to hear of anyone experiencing an adverse event with any medical device," she said.
"We make the health and wellbeing of our patients, and the integrity of all of our products, an absolute priority."'Paint your bedroom walls red'
Despite Ms Davidson's health issue, it wasn't the worst experience she had with a gynaecologist.
That happened when she went to one in regional Victoria with her series of symptoms, including loss of libido.
"I got told I should paint a wall in my bedroom red and that was suddenly going to make everything perfect again," Ms Davidson said.
What she was actually experiencing was a nickel allergy, from the nickel inside her Essure.
Ms Davidson now has to make an eight-hour round trip from Swan Hill in northern Victoria to Melbourne, to visit a heavy metals toxicologist who is helping her deal with the remaining nickel shards in her body, eight years after she first had the device implanted.
To this day she suffers cognitive problems, weight gain, relationship problems, and bears a constant reminder of her ordeal in the form of a nickel rash on her face.
"I know it's not just me and I know there are thousands of women out there like me," she said. "I deserve to be told 'I'm sorry we did this to you'."
Dr White said physicians should take patients seriously.How many Australian women are affected?
It's not known how many Australian women have an Essure device and Bayer said it was unable to release its Australian sales figures for "commercial reasons".
However, private health insurers told the ABC they paid for more than 1,000 devices between 2005 and 2017.
It includes Bupa (379), Medibank Private (320), HCF (228) and NIB (113), and together they control just under three-quarters of the health insurance market.
With private health making up just under half of the health sector, that equates to an estimated 3,097 Australian women with the devices — but potentially more when private patients treated in the public system are included.
The Facebook page Essure Problems Australia has just under 300 members and Health Issues Centre chief executive Danny Vadasz said they had been contacted by about 100 women with problems.
It is the latest women's health device to be subject to public concerns including vaginal mesh for prolapse and incontinence, and the Mirena intra-uterine device.Should women with Essure be concerned?
The Royal Australian and New Zealand College of Gynaecologists and Obstetricians told the ABC those women with an Essure should contact their GP or specialist if they have any concerns about symptoms.
"My advice would be if a woman has had an Essure and she has not had problems with it, I think she does not have any grounds for concern," Dr White said.
"For women who have got a device and do have symptoms, and that might be pain or abnormal bleeding or other symptoms, they should have those symptoms evaluated thoroughly."
She said the problems with Essure showed the way devices were regulated needed to be reviewed.
"Both the issue around mesh procedures and now Essure does warrant some assessment," she said.
"Do we really have a sufficiently rigorous enough system in place to evaluate devices both before and after they are put into use, and maybe there is evidence that we do need to tighten up."
In a statement, a Bayer spokeswoman said there were more than 40 published studies on Essure involving more than 200,000 patients worldwide that supported its use.
"Women who currently have Essure in place may continue to use the device, and Bayer will continue to support healthcare providers in their management of these patients," it said.
"We encourage women who have any questions about Essure to contact their healthcare provider."
Ms Davidson said it was simply not good enough.
"I'm a firm believer that if there was a male implant, the minute there had been side effects it would have been taken off the market," she said.
"But because we're women I just feel we're the secondary class and it doesn't seem to matter.
"It's all about being the next person to develop the next best thing, I don't think it has the patient's best interest at heart."
http://www.abc.net.au/news/2018-08-13/essure-contraceptive-device-now-class-action-bayer/10106194
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