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Ethicon Media Monitoring 7/23/2018
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The Bleeding Edge Movie Review
Jul 22, 2018 | Shockya.com
By Harvey Karten
Who better to expose the rampant corruption in the medical devices industry than Kirby Dick? -
‘I was worried everything would fall out’, says woman whose pelvic floor gave way
Jul 21, 2018 | Today Online
By Eveline Gan
For more than 30 years, mother-of-two Teo Kim Geok did the heavy lifting when it came to household chores and grocery shopping. -
Vaginal mesh suspension: 'More work needs to be done', say Sling the Mesh in Essex
Jul 21, 2018 | Daily Gazette
By Vicky Gayle
The announcement that the Government will suspend the use of vaginal mesh during operations until further notice is only a partial victory, a Clacton campaigner has claimed. -
Ban on mesh implants should become permanent
Jul 23, 2018 | The Irish News
By Margaret Ritchie
Away back in 2015/2016 I was approached by female residents in south Down regarding the pain and discomfort they had and were continuing to suffer as a result of the insertion of mesh implants to correct urinary incontinence.
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The Bleeding Edge Movie Review
Jul 22, 2018 | Shockya.com
By Harvey Karten
Who better to expose the rampant corruption in the medical devices industry than Kirby Dick? The muckraking documentarian has knocked out hard-hitting films like “The Hunting Ground” which covers rape and cover-ups on college campuses, “The Invisible War” about the rape of soldiers in the U.S. military (likewise covered up), and “Outrage,” about the hypocrisy of closet legislators who talk big about the need for anti-gay legislation. I wonder what Mr. Dick and co-writer Amy Ziering—who co-wrote and acted in “The Invisible War”—would think of President Trump’s recent declaration that for every new regulation he would sign, he would shred two other regulations? That one has an obvious answer: Trump is in the sack with Big Business just as are the presumed regulators of drug and medical devices in the Food and Drug Drug Administration who, upon leaving the FDA at the end of their terms serve as lobbyists for the industries they were regulating. Not only that: these former government officials, now with jobs paying greater than three times more than they received from the government, tell the drug and device companies how to get around FDA regulations. (In the same manner, of course, former employees of Internal Revenue have been known to tell the private industries they now work for how to get around, i.e. cheat, on their taxes.)
In the Netflix doc “The Bleeding Edge” Kirby Dick takes aim against four industries that use medical devices: the da Vinci robotic surgery device, materials used for hip replacements, the mesh used in gynecological surgeries, and most of all a specific company, Bayer, that manufactures Essure, which are implants for birth control. Most of the individuals interviewed in the cast, filmed by Thaddeus Wadleigh with Jeff Beal’s music to intensify the drama, are women, none of whom give much praise to the device which had been sold to the public presumably because it’s new. This is a metal coil claimed to be 99%+ effective at preventing pregnancy, which sounds great—until you realize that 65,000 women are parties to lawsuits against its manufacturer. They get their chance to announce their frustrations to moviegoers, warning them of the possibility that their audience, like them, may suffer from cramps and bleeding requiring the removal of a device that is said to be for a lifetime and not removable. They recommend the good old fashioned tried-and-true surgery to tie their tubes, a tubal ligation, which like Essure takes only minutes for a gynecologist to process and to our knowledge has not met with horrendous side effects. To top it off, a video taken at an approval meeting, members of the government committee joke about dissenting voices. Ultimately the only thing that the FDA does to regulate Essure—forget about having them take it off the market—is to require doctors to advise patients of side effects.
We are not made to accept foreign bodies easily, though there are some proven techniques like implantation of pacemakers for heart patients that have saved lives. Under the microscope here, though, is the vaginal mesh used to hold tissues in place. One woman’s experience will not soon be forgotten by those watching the movie. When the mesh became rigid—and her husband became rigid—the poor man receives a cut on the tip of his penis. So movies like “Teeth,” a horror film that has overly aggressive men and rapists lose most of their penis from women who have implanted teeth into their vagina, creating “vagina dentate,” are not so far out. Statics are invoked that Johnson and Johnson lost $300 million from lawsuits against earnings of $683 billion during the same period.
Robotics surgery is touted now as New! New! New! Doctors urging some patients to avoid the need for trauma as doctors are able to manipulate a million dollar machine for some procedures. Yet because the system is new and because hospitals that have invested in the machines have a need to use them, some doctors are not fully trained. In one horrific case we come across a woman who had three feet of her colon falling out of her body. No, this is not a film by Rob Zombie or Eli Roth or Wes Craven.
Many of us will need hip replacements at some point in our lives. We wear out, just like computers and cars. Some folks interviewed here have had replacements made with cobalt, and one orthopedic surgeon, himself a patient who should have known better, had tremors and memory loss because, one again, the body is not friendly to spare parts. In his case the metal got into his bloodstream. Did that stop the use of cobalt? Guess.
If you’re one of the exceptional people who blow the whistle, you’re likely to get fired, and in fact nine FDA officials who warned that the commission is too lax were fired. Maybe that made an impression on current staff members. Not a single one from the agency or, for that matter, any rep from the companies being criticized agreed to be interviewed.
By now you should realize that this is a documentary that should be seen by all, as none of us who live to a ripe old age can avoid having to make decisions on treatments.
http://www.shockya.com/news/2018/07/22/the-bleeding-edge-movie-review/
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‘I was worried everything would fall out’, says woman whose pelvic floor gave way
Jul 21, 2018 | Today Online
By Eveline Gan
For more than 30 years, mother-of-two Teo Kim Geok did the heavy lifting when it came to household chores and grocery shopping.
Her routine took a toll, but Mdm Teo was none the wiser until last year, when her pelvic floor gave way and her womb, bladder and rectum slipped out of their normal positions.
She experienced light bleeding and an obvious bulge at the opening of the vagina whenever she stood up.
But a group tour to Taiwan with her husband beckoned at the time and, not wanting to disrupt their plans, Mdm Teo, 60, kept mum about her discomfort and proceeded with the seven-day trip.
“Although it wasn’t painful, it was very uncomfortable. Each time I stood up or walked, a piece of flesh would protrude out. I was really worried that everything would simply fall out, and kept looking for a place to sit down during my trip,” Mdm Teo said candidly.
“I had never heard of pelvic organ prolapse but I suspected that something was wrong with my uterus.”
She sought treatment at the KK Women’s and Children’s Hospital (KKH) immediately after returning home.
Although it is one of the common conditions affecting women aged 45 to 75, doctors say public awareness of pelvic organ prolapse remains low. The urogynaecological condition occurs when the pelvic organs such as the uterus, bladder, urethra, rectum and vagina fall out of their normal positions due to a weakened pelvic floor.
It is estimated that half of all women have mild prolapse (Stage 1) after the age of 30 and 10 per cent have its moderate to severe forms, said Associate Professor Han How Chuan, head and senior consultant of KKH’s department of urogynaecology.
The majority of the women – or about three in five – who sought treatment for the condition at KK Urogynaecology Centre were severe cases that are usually more complicated and difficult to treat.
The centre managed about 2,800 new cases of urogynaecological conditions annually in the last five years, and saw about 1,200 women with pelvic organ prolapse from 2012 to 2016.
Some of the most complex cases that Assoc Prof Han has seen involve patients with severe pelvic organ prolapse, who also suffer from other medical conditions such as a history of heart attack and stroke. This group of patients may not be suitable for surgery due to the risks of undergoing anaesthesia and may have to live with the condition.
“Some women wait a long time and by the time they seek treatment, the bulge (of tissue) is already outside (the vaginal opening). This isn’t something that will recover on its own over time,” said Assoc Prof Han, adding that early treatment is key to achieving good health outcomes.
Some women do not know treatment is available or where to seek treatment, said obstetrician and gynaecologist Lee Lih Charn. At her practice at Mount Elizabeth Novena Hospital, however, less than 10 per cent of patients show up when their condition has reached the late stage.
Although pelvic organ prolapse through the vagina affects only women, both women and men may encounter rectum prolapse through the anus, but such an occurrence is rarer, said Dr Lee.
A HEAVY SENSATION
There are usually no obvious symptoms of pelvic organ prolapse in the earliest stage, which can be detected during a Pap smear test. But some women may experience a heavy sensation that feels like “something is dropping out” of the vaginal opening, or have lower-back ache, said Assoc Prof Han.
Other symptoms include difficulty having sexual intercourse, passing urine or motion (in severe cases) and chronic vaginal discharge or bleeding that results from repeated injury to the prolapsed organ.
Menopause, pregnancy and vaginal births are risk factors for pelvic organ prolapse.
Conditions that increase the pressure in the abdominal cavity over long periods of time can also affect the pelvic floor, said Assoc Prof Han. They include chronic cough, constipation, obesity and the carrying of heavy loads or objects.
About 5 per cent of the patients he sees have never gone through pregnancy.
While uncommon, Assoc Prof Han has also seen younger women in their early 30s who experience pelvic organ prolapse after childbirth, due to pregnancy and delivery weakening the pelvic floor. Complicated deliveries requiring forceps or vacuum intervention can also raise their risk.
Pelvic floor exercises, or Kegel exercises, can lower the risk of prolapse, but not all women are aware of it.
In a recent KKH study involving 100 pregnant women in their third trimester, up to 40 per cent of them did not know that pelvic floor exercises during pregnancy could help prevent urogynaecological disorders like urinary incontinence after childbirth. About 35 per cent reported symptoms of pelvic floor disorders but none sought medical attention.
“Ideally, women should start daily pelvic floor exercises before and during their pregnancy. Like any muscle, it’ll get better if you keep training it,” said Assoc Prof Han, who cautioned against lifting heavy loads exceeding 8kg for prolonged periods of time.
Using a baby carrier, sling or haversack may help to distribute the weight of the load to other muscles around the shoulders, he said.
Other preventive measures include avoiding straining while passing urine, and having healthy bowel habits by drinking sufficient fluids and consuming enough fibre to prevent constipation.
COMPLICATIONS CAN BE SERIOUS
While the condition is not usually life-threatening, the more severe cases can affect patients’ quality of life due to the discomfort and pain.
Serious complications have been known to arise from pelvic organ prolapse. For instance, bladder prolapse can lead to recurrent urine infections, which can potentially progress to kidney infection or septicaemia (a potentially life-threatening blood infection), said Dr Lee.
A 2013 KKH study found that more than a fifth (22 per cent) of patients with severe pelvic organ prolapse suffer enlargement of the kidney due to a buildup of urine, said Assoc Prof Han. Three per cent had kidney failure, according to the study involving 121 patients.
Conservative and surgical treatments are available, but not every patient requires surgery. Patients with milder degrees of prolapse may consider using non-surgical treatment in the form of pelvic floor exercises, which can help slow down the progression of the prolapse although they cannot cure it.
Patients with more severe forms of the disorder, but who are not suitable for surgery or do not wish to undergo surgery, may consider having a device called vaginal pessary fitted to support the prolapsed organ, said Assoc Prof Han. One of its downsides is the need for regular follow-ups and changing of the pessary.
Several surgical options are available to manage pelvic organ prolapse. Mdm Teo, whose condition was considered moderate, chose to undergo surgery to remove her womb, repair her pelvic floor, as well as place a mesh attached to ligaments in the pelvic area to support the bladder.
At a follow-up doctor’s visit last month, she showed no signs of prolapse or any urinary symptoms.
Mdm Teo, whose sons are in their 30s, no longer dares to carry or lift heavy items. Urging women to seek help early, she said: “We women should learn to take care of ourselves. I now leave the heavy lifting to my husband.”
https://www.todayonline.com/singapore/i-was-worried-everything-would-fall-out-says-woman-whose-pelvic-floor-gave-way
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Vaginal mesh suspension: 'More work needs to be done', say Sling the Mesh in Essex
Jul 21, 2018 | Daily Gazette
By Vicky Gayle
THE announcement that the Government will suspend the use of vaginal mesh during operations until further notice is only a partial victory, a Clacton campaigner has claimed.
Baroness Julia Cumberlege, who chaired a major review, has put forward conditions to be met by March 2019 before mesh – used to treat stress incontinence and pelvic organ prolapse – can be considered safe again.
The Department of Health and NHS England have accepted the recommendations.
June Faircloth, of Clacton, who launched Sling the Mesh in Essex, met Baroness Cumberlege with other members to share her harrowing experiences due to mesh complications.
June said: “She sat there mortified. I think she was in total shock.
“We put a list together of what we’d like to see happen and the support needed now and for the future.
“There’s still work to be done. Since the suspension went through, it’s been said the NHS will still use it on an emergency basis, which is still risky.
“Plus, this is only one of three meshes – rectal and hernia mesh haven’t been banned. Lots of men are suffering too.
“In my case, the mesh has compressed against itself and is damaging my internal organs.”
Both June, 49, and her husband have suffered surgical mesh complications which the mum-of-two needed after the birth of her 10lb 6oz daughter, now 29.
She had two types of mesh implanted in the mid 2000s to anchor her womb due to incontinence, which then needed repairing about six years later in 2013.
Chronic pain plus incontinence meant she was unable to hold things together at work, but some of her symptoms were blamed on the menopause.
She went from being an active person to needing crutches and sometimes a mobility scooter having had three back operations while the real cause went undetected.
She said: “It’s been horrendous and has got to the point where it’s really got me down. I’m also angry because everyone thinks it’s in your head.
“I’m at the stage now where just trying to walk to town, which used to take 10 minutes, now takes 45, and the pain means I can’t do anymore.
“My life is on hold.”
It was not until seeing the national Sling The Mesh group on the TV that June realised the mesh was to blame for her physical difficulties.
Fortunately, she was able to get diagnosed by a private specialist and is now but is back on the NHS awaiting further NHS treatment.
Search Sling the Mesh in Essex on Facebook for more information.
http://www.gazette-news.co.uk/news/16359267.vaginal-mesh-suspension-more-work-needs-to-be-done-say-sling-the-mesh-in-essex/
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Ban on mesh implants should become permanent
Jul 23, 2018 | The Irish News
By Margaret Ritchie
Away back in 2015/2016 I was approached by female residents in south Down regarding the pain and discomfort they had and were continuing to suffer as a result of the insertion of mesh implants to correct urinary incontinence.
Such was their persistent pain and agony that I tabled a motion in Parliament which gained cross-party support urging an end to the use of mesh implants.
This campaign to end such implants gained momentum last year when campaigning groups were formed and MPs continued to lobby for an end to their use. The women also had medical support for their campaign from a consultant in London.
Eventually, the NHS in England issued a statement two weeks ago banning their use followed by a Statement from the Department of Health in Belfast imposing a ban on their use in Northern Ireland. I would hope that the temporary ban on the use of mesh implants could become permanent.
Tribute must be paid to the women in Northern Ireland who while enduring ongoing piercing pain continued with their worthwhile campaign.
I salute those women for their fortitude and hope that the ban on the use of vaginal mesh implants becomes permanent and that other measures are investigated and implemented to correct urinary incontinence which will not cause the same level of pain and discomfort.https://www.irishnews.com/opinion/letterstotheeditor/2018/07/23/news/sf-has-criminalised-republican-armed-struggle-1387219/
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