Preview Newsletter
Ethicon Media Monitoring 06/24/16
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Pelvic Mesh Implant Procedures Halted in Scotland
Jun 23, 2016 | Mesh Medical Device News Desk
Journalist Marion Scott continues her headline-making reporting on pelvic mesh implant procedures for Scotland’s Daily Record. -
Opioids for Pelvic Pain – What Are the Alternatives?
Jun 23, 2016 | Mesh Medical Device News Desk
This story in the New York Times illustrates how difficult it is to reduce the widespread use of painkillers such as OxyContin and Percocet. -
TOUGH LOVE: A Valentine for the Guys of OBGYN
Jun 23, 2016 | Mesh Medical Device News Desk
By Katharine Hikel
I’m having flashbacks. I’m in an operating room at UVM Medical Center. A woman, anesthetized, out cold, lies on her back on the table, legs apart, feet strapped into metal stirrups. -
Kitchener woman creates simple solution for pelvic prolapse
Jun 23, 2016 | The Record
By Johanna Weidner
...The Kitchener woman needed to find a way to live with the uncomfortable and often limiting condition of a pelvic organ prolapse. -
New frontier: Botox in the bladder to help stop that urge
Jun 23, 2016 | Miami Herald
By Kathryn W. Foster
Women have new help when it comes to those taboo topics like incontinence and pelvic organ prolapse. While urology is a male-dominated field, there is a growing subspecialty that deals with conditions stemming from the unique anatomy of the female urinary tract and reproductive system. -
The Health Care Complaints Commission has had a 25 per cent increase in serious complaints in one year | poll
Jun 23, 2016 | Newcastle Herald
By Joanne McCarthy
THE State’s health watchdog recorded a 25 per cent increase in the number of serious complaints about doctors and other health professionals in one year, a NSW parliamentary committee inquiry has found.
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Pelvic Mesh Implant Procedures Halted in Scotland
Jun 23, 2016 | Mesh Medical Device News Desk
Journalist Marion Scott continues her headline-making reporting on pelvic mesh implant procedures for Scotland’s Daily Record.
On Tuesday, Health Secretary Alex Neil suspended surgeries using pelvic mesh (transvaginal mesh) for pelvic organ prolapse (POP) or to treat stress urinary incontinence (SUI) pending an independent safety audit. A national review will begin early next year. Patients who are awaiting pelvic mesh surgery will be contacted and offered alternatives.
Also part of the decision, doctors are being urged to report complications to any pelvic procedure, not just mesh. Neil will include patient advocates in the review and they will be brought into a final decision.
This is the culmination of campaigners in Scotland including Linda McLaughlin who was the first to address parliament to expose the life-altering aftermath of pelvic mesh surgery.
Hear Our Voice campaign and Scottish Mesh Survivors members were present for the surprise announcement. Olive McIlroy, 57 and Elaine Holmes wept with joy, Scott reports, as Neil made the announcement.
“Mesh firms spend millions on research and funding and we cannot have anyone who has been involved in that work heading up the review. We need someone with an open mind who will put patients first,” said McIlroy.
Lorraine McCorquodale, 58, of Dundonald, Ayrshire, who is about to have her 15th op in five years to remove mesh tape, said: “I just hope Alex Neil stays strong because the powerful, wealthy companies who sell these devices have influence everywhere.
“We always knew our fight wouldn’t benefit any of us but no other women will have to share our nightmare and that is enough for us.
When Alex Neil uttered the words, ‘We will be suspending mesh…’, it took a few seconds to sink in, writes JEFF HOLMES.Pelvic Mesh Implant Procedures Halted in Scotland
Scottish Health Sec. Alex Neil
Mesh Medical Device News Desk, June 23, 2016 ~ Journalist Marion Scott continues her headline-making reporting on pelvic mesh implant procedures for Scotland’s Daily Record.
On Tuesday, Health Secretary Alex Neil suspended surgeries using pelvic mesh (transvaginal mesh) for pelvic organ prolapse (POP) or to treat stress urinary incontinence (SUI) pending an independent safety audit. A national review will begin early next year. Patients who are awaiting pelvic mesh surgery will be contacted and offered alternatives.
Also part of the decision, doctors are being urged to report complications to any pelvic procedure, not just mesh. Neil will include patient advocates in the review and they will be brought into a final decision.
This is the culmination of campaigners in Scotland including Linda McLaughlin who was the first to address parliament to expose the life-altering aftermath of pelvic mesh surgery.
Elaine Holmes addresses Parliament
Hear Our Voice campaign and Scottish Mesh Survivors members were present for the surprise announcement. Olive McIlroy, 57 and Elaine Holmes wept with joy, Scott reports, as Neil made the announcement.
“Mesh firms spend millions on research and funding and we cannot have anyone who has been involved in that work heading up the review. We need someone with an open mind who will put patients first,” said McIlroy.
Lorraine McCorquodale, 58, of Dundonald, Ayrshire, who is about to have her 15th op in five years to remove mesh tape, said: “I just hope Alex Neil stays strong because the powerful, wealthy companies who sell these devices have influence everywhere.
“We always knew our fight wouldn’t benefit any of us but no other women will have to share our nightmare and that is enough for us.
When Alex Neil uttered the words, ‘We will be suspending mesh…’, it took a few seconds to sink in, writes JEFF HOLMES.
Women who still want a mesh implant will be able to have one with full details on the procedure and its complication rate.
The campaigners had asked for mandatory reporting of all adverse incidents by health professionals, a Scottish Transvaginal Mesh implant register, a fully informed patient consent, along with the mesh use suspension.
In October of last year, the Scottish government said it would no longer recommend three of the four procedures routinely recommended to treat incontinence and pelvic organ prolapse. Scottish Mesh Survivors, Hear Our Voice campaign and Marion Scott’s insistent and consistent reporting largely made the difference. See the background story on Mesh News Desk here.
Back then Marion Scott told Mesh News, “The mesh victims played a huge role in writing the patient information leaflets and they have ensured all possible side effects are explained clearly. The SUI leaflet has already been done and they are working on the POP leaflet as we speak. This is a great example of what can be achieved. I’m so proud of all these incredible women who put their own pain to one side and pushed for these changes so no other women need suffer. They really are incredible.”
Scott won Reporter of the Year, 2015 for her grabbing headline and front-page news.
October 2013, both Dr. M. Tom Margolis and Shlomo Raz added their letters to the voices of mesh victims in speaking to members of the parliamentary health committee. See the story here.
http://www.meshmedicaldevicenewsdesk.com/pelvic-mesh-implant-procedures-halted-scotland/
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Opioids for Pelvic Pain – What Are the Alternatives?
Jun 23, 2016 | Mesh Medical Device News Desk
Douglas Scott got an ultimatum from his wife – wean yourself off opioid medication, he began to treat pain after two car accidents, or expect changes at home. Today Mr. Scott is narcotics free. Instead he entered a program and spent five weeks, six hours a day training in alternative pain management techniques. They include relaxation exercises, behavior modification and physical therapy.
This story in the New York Times illustrates how difficult it is to reduce the widespread use of painkillers such as OxyContin and Percocet.
As part of a nationwide trend to reduce the abuse of pain drugs, doctors are being urged to first treat pain without using opioids. That has been the traditional course of treatment for women suffering pelvic pain after a transvaginal mesh implant when the doctor no longer understands how he can address her complications.
Other avenues include chiropractic and osteopathic manipulation, acupuncture, yoga, massage, meditation. Problem is most insurance has not kept up with the push to limit opioids and may not cover these alternative treatments. Medicaid may cover physical therapy under the Affordable Care Act but that varies by state. Historically when limits were placed on coverage, these alternatives to opioids were the first to go. Now Medicaid must grapple with adding them back.
There is a National Pain Strategy that was issued in March that outlines ways to improve pain care in America.
The Mayo Clinic in a 2008 study found that alternatives to opioid use led to a significant improvement in function and less pain.
In Mr. Scott’s case, he now admits he was addicted to oxycodone and morphine. His treatment in alternatives led him to Brooks Rehabilitation in Jacksonville, Florida. Workers’ compensation and Aetna and United Healthcare cover the program’s costs. Blue Cross and Blue Shield of Florida does not. In a statement, Florida Blue said some alternative treatments are experimental and unproved. State Medicaid plans have not traditionally covered a range of alternative programs, but now with the national push to reduce opioid addiction, has prompted some states to consider passing legislation to develop pilot programs to incorporate acupuncture, chiropractic, cognitive behavioral therapy, massage, exercise, yoga and osteopathic manipulation. Oregon leads the nation in providing such treatments.
Mental health counselling is also being recognized as a necessary component to pain drug addiction. ##
http://www.meshmedicaldevicenewsdesk.com/opioids-pelvic-pain-alternatives/
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TOUGH LOVE: A Valentine for the Guys of OBGYN
Jun 23, 2016 | Mesh Medical Device News Desk
By Katharine Hikel
I’m having flashbacks.
I’m in an operating room at UVM Medical Center. A woman, anesthetized, out cold, lies on her back on the table, legs apart, feet strapped into metal stirrups. A surgeon (in my experience, invariably a man) invites a lineup of residents and medical students (in my experience, invariably men) – half a dozen or so – to take turns practicing vaginal exams on her, to ‘feel the pathology.’
That form of sexual assault was, and is, practiced at teaching hospitals everywhere. It was the perfect situation for inexperienced, ham-handed, or predatory guys. They had support and approval. There was no feedback from the patient. They did their thing, then got out of the way for the next guy.
The words ‘rape culture on college campuses’ brought these memories back, with this question: is anyone looking at the culture of medical schools, with regard to women patients in obstetrics and gynecology departments?
I mentioned this to a med-school classmate, now an emergency doc in Boston. He knows trauma. He said, “I’ve never forgotten what it was like to see that. It was something I refused to do.”
I also refused. I regret not yelling “Stop!”
A gynecologist friend provided an update on the ‘exam under anesthesia’ at the University of Vermont Medical Center: ‘Women are introduced to the students who would perform the exam. A patient can talk with them before she signs the consent form.”
Where does this meeting occur?
“In the pre-op holding area,” she said.
Experts in bias and discrimination would call this micro-aggression: putting a woman in setting that appears friendly, but is set up for submission.
Woman-centered care would have OBGYN surgeons propose these unnecessary procedures in the office visit before surgery, with the patient fully clothed, when she might take the paperwork home and think about agreeing to serial vaginal exams by strangers. But that’s not the culture.
Men in women’s health do things ‘to’ women – not ‘with’ us.
Crimes Against Nature
Along with the ‘exam under anesthesia’, I observed births with an obstetrician who manually dilated laboring women’s cervixes – ripping the sides open with his fingers to get the baby out faster, then repairing the ‘lacerations.’ Incident reports were collected about this (I know; I wrote one). This guy had great bedside manner: “Patients love him,” said the nurses. Residents voted him ‘Teacher of the Year.’ He’s now director of a division. Is this the ‘trusted clergyman’ model of abuse? Is that why he keeps getting promoted, instead of being put, oh, I don’t know, say, on the sex offender registry where he belongs?
When I told my boss that I wanted to write about the man problem in women’s health, she said, “And can you make it funny?” Holy Mother, help me here.
The culture of OBGYN developed like any men’s club or frat which defines women as ‘other.’ Because of the pressure to conform, it’s not unusual to hear women patients and providers – nurses, midwives – say, half-kiddingly, “The women in OBGYN are as bad as the men.”
Meanwhile, UVM Medical Center, through all of its name changes, has never had a woman in charge of women’s health.
It’s not just us. This is a nationwide problem.
Though obstetrics and gynecology now has the largest proportion of women residents of any specialty – 81 percent — only 20.4 percent of academic OBGYN department chairs are women. The American Congress of Obstetricians and Gynecologists (ACOG) – the national governing organization – is also dominated by men. It’s a fraternity. You don’t play, you don’t stay.
Men running OBGYN is why we have a 30% surgical-birth rate in Vermont and in the USA; why uterectomy – ‘hysterectomy’ – and surgical birth are the two most common surgical procedures performed on women.
The guys of OBGYN promote ‘active management’ – pushing birth to occur in 12 hours or less, and eliminating natural childbirth as the norm.
This is a classic Raging Hormone problem. Childbirth is regulated by oxytocin – the hormone of love, connection, and bliss. Guys are regulated by testosterone – the hormone of aggression, dominance, and My Way Or The Highway.
As in, who’d you rather have in the birthing room – Artemis, the Goddess of Light and Compassion, or Attila The Hun?
OBGYN surgeons now want to be our ‘primary care providers. This is the main obstacle to woman-centered, patient-centered care. The problem is that we’re not dealing with the profession of medicine; we’re dealing with corporate culture – another fraternity. Women use more health services than men; we’re charged more for coverage; and we earn less. So not only are they raping us; they’re bleeding us dry.
http://www.meshmedicaldevicenewsdesk.com/tough-love-valentine-guys-obgyn/
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Kitchener woman creates simple solution for pelvic prolapse
Jun 23, 2016 | The Record
By Johanna Weidner
KITCHENER — Marilyn Lincoln was desperate for help.
The Kitchener woman needed to find a way to live with the uncomfortable and often limiting condition of a pelvic organ prolapse.
"I was desperate. I was upset. I was depressed," Lincoln said. "I was looking for any solution that was going to help me."
But she couldn't find anything suitable, so she set out to design one herself. Just over a year ago, she launched a website to get her support garment called Hide-a-way out to other women dealing with a prolapse.
"I was blown away by the emails I got," Lincoln said of the response.
Women from all over the world have ordered a Hide-a-away, many writing to Lincoln to say it changed their lives, and two specialists in Canada and the United States are studying its effectiveness on their patients.
"I am really, really happy helping these women," Lincoln said.
A pelvic organ prolapse occurs when a pelvic organ, most commonly the bladder, drops from its normal place in the lower belly and pushes against the vaginal wall. It can happen when the muscles that hold pelvic organs in place get weak or stretched.
If symptoms are mild, special exercises can help along with avoiding lifting heavy items and being a healthy weight. A pessary, a removable vaginal device, can help some people if symptoms persist or, in serious cases, surgery is an option.
Lincoln was shocked when she suddenly developed a bladder prolapse 11 years ago.
"I never heard of it and it was terrifying," she said.
Her goal was to make something comfortable and supportive. What she came up with was a supportive sling with adjustable elastic bands, inspired by the old-fashioned menstrual pads held in place with a belt.
"It is simple. I really wanted something that all ages could use," she said.
The Hide-a-way, which is made by a custom seamstress in Hamilton and is patent pending, sells for $39.95 plus shipping and tax.
It can be worn over or under underwear, providing support to stop a prolapse from protruding out of the body.
"It reduces the feeling of the prolapse and it reduces the pain," Lincoln said.
"It's going to give you the support you need to go about your business."
Lincoln has been wearing one for a year and, she said, "I wouldn't think of a day without it."
She said many women don't go to their doctor because they're embarrassed about the condition, and instead curtail their activities to avoid the discomfort that comes with it.
"I know there's other women out there suffering and I want to help them," Lincoln said. "You can live with a prolapse."
http://www.therecord.com/news-story/6738222-kitchener-woman-creates-simple-solution-for-pelvic-prolapse/
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New frontier: Botox in the bladder to help stop that urge
Jun 23, 2016 | Miami Herald
By Kathryn W. Foster
Botox has been linked to helping urge incontinence
Therapy, medications and minor surgery can help treat women’s urology issues
Kegel exercises can strengthen muscles
Women have new help when it comes to those taboo topics like incontinence and pelvic organ prolapse. While urology is a male-dominated field, there is a growing subspecialty that deals with conditions stemming from the unique anatomy of the female urinary tract and reproductive system.
Dr. Yvonne Koch, a urologist at Mount Sinai Medical Center, specializes in the urological conditions that commonly affect females.
"My subspecialty is female urology, and voiding dysfunction. These are problems that tend to affect more women than men. My practice is approximately 70 percent women and 30 percent men," Koch said.
As part of her subspecialty, Koch sees women with pelvic floor dysfunctions, urinary tract infections and bladder infections.
The official title for the subspecialty is Female Pelvic Medicine and Reconstructive Surgery, a board certification that is relatively new.
Dr. Eric Hurtado, a urogynecologist at Cleveland Clinic Florida in Weston who is also certified in Female Pelvic Medicine and Reconstructive Surgery, says the subspecialty has been board-certified for about three years.
"It's a real conversation stopper at parties," Hurtado said of his profession. "I tell people I like plumbing," he added.
Leaking "pipes" are no laughing matter for women. Stress incontinence, leakage when you cough, laugh or exercise, is different from urge incontinence, in which the bladder contracts when it's not supposed to, causing women to wet their pants.
Both doctors mentioned numerous treatment options such as therapy, medications and minor surgery.
For stress incontinence, Koch said, "we can do cognitive therapy, we can do slings, we can inject bulking agents in the urethra."
Patients can also do Kegel exercises, contracting the muscles that control urine flow, to help strengthen the pelvic floor. Hurtado recommends doing a set of Kegel exercises three to five times a day, holding for 10 seconds, then relaxing for 10 seconds, and repeating 10 to 15 times. "Compliance is the hardest part," he said.
For urge incontinence, "physical therapy and oral medications can help. There are approximately seven medications on the market for this problem. If that doesn't help, we can also put Botox in the bladder or use an InterStim device," Koch said.
InterStim is a pacemaker-type device placed under the skin that sends electrical impulses to the nerves to modify the impulses to the bladder. Another procedure is posterior tibial nerve stimulation, called PTNS.
"Sometimes, people with a little bit of both types of incontinence need what we call multimodality, a little bit of this and a little bit of that," Koch said.
Even less talked about is pelvic organ prolapse in which "the muscles can no longer support the pelvic organs from below," Hurtado said.
"One in nine women in the U.S. will have surgery for pelvic floor prolapse," Hurtado said. Yet many patients have no idea if their grandmother, for instance, had the same problem. It's just not something people discuss.
The most common symptom is a protrusion, something coming out of the vaginal opening. There can also be pelvic pressure or trouble moving bowels or urinating. Hurtado said.
"A lot of women who have prolapse also have incontinence and vice versa," Hurtado said.
Not all cases require surgery. When it's needed it can be done vaginally, laparoscopically, robotically or as open abdominal surgery. You can use your own tissues and ligaments or mesh for reinforcement, Hurtado said.
There are pros and cons for all the methods although there are fewer and fewer doctors inserting mesh vaginally as there are more complications of the mesh coming through the pelvic wall, Hurtado said.
"It's important to customize your surgery to the patients, how active they are, how old. When you use your own ligaments and tissues, there's a little higher failure rate, especially for your active patient," Hurtado said.
"Everything has a little bit of Catch-22. Otherwise, we'd all do the same thing every time," Hurtado said of treating pelvic organ prolapse.
"There's a lot to be learned," Hurtado said, adding, "It's a new frontier of medicine."
http://www.miamiherald.com/living/health-fitness/article85372077.html#storylink=cpy -
Jun 23, 2016 | Newcastle Herald
By Joanne McCarthy
THE State’s health watchdog recorded a 25 per cent increase in the number of serious complaints about doctors and other health professionals in one year, a NSW parliamentary committee inquiry has found.
The NSW Health Care Complaints Commission (HCCC) received more serious complaints between July 2015 and the end of March 2016 than a comparable period a year earlier, took longer to finalise the complaints and prosecuted significantly more, said the Health Care Complaints Performance Report released on Thursday.
The HCCC expected all complaints to increase further, up from about 3900 in 2013/14 to an estimated 5900 in 2016, the report said.
Treatment in public hospitals and access to public hospitals were the two largest single areas of complaint, said Port Stephens MP Kate Washington, who is a member of the HCCC parliamentary committee.
Ms Washington and Shadow Health Minister Walt Secord said the performance report showed the funding of the body was not keeping pace with the sheer volume of complaints, and the NSW Government had a responsibility to reduce the number of patients dropping complaints due to the protracted nature of the complaints process.
Unacceptable: Port Stephens MP Kate Washington, a former health lawyer, said the increased level of serious complaints to the Health Care Complaints Commission was disturbing and the response times were unacceptable.
A Hunter patient who lodged a serious complaint against a health specialist more than two years ago said the HCCC needed immediate and substantial resources to clear a backlog of cases.
But serious questions needed to be asked about the NSW Medical Council and its processes that allowed doctors who were the subject of serious investigations to continue working for extended periods until complaints were finalised, the Hunter patient said.
“If a football player does something that leaves another player injured that player is sidelined until the complaints process is finalised,” the Hunter patient said.
“That’s what needs to happen with doctors. It’s the NSW Medical Council, and not the HCCC, that’s responsible for sidelining doctors during investigations or after complaints. I believe the threshold on taking action against doctors after serious complaints are made is way too high, and is not in the best interests of the public.
“As it stands at the moment these complaints are taking a very long time to be investigated, and the doctors who are the subject of these serious complaints should be stood down and sufficient deterrents put in place so that people are protected.”
A former Newcastle University associate professor of gynaecology under investigation by the HCCC since 2014 over use of mesh devices in women’s prolapse surgery is promoting “vaginal ageing” laser procedures in Sydney nearly 20 years after he was suspended in America after findings of incompetence involving women’s pelvic laser surgery.
Dr Richard Reid is promoting the laser surgery while barred from performing major surgery after a failed NSW Medical Council attempt to suspend him.
Dr Reid was fined $10,000 by the Michigan Medical Board in 1998 and suspended for three months after complaints from three women, aged 23, 50 and 59, following laser surgery that “violated his duty to safely and skilfully practise medicine”.
One of the women, 23, received a $7.6 million compensation payout after an American court was told she could never have sex again because of permanent and severe damage caused by the Australian doctor.
The NSW Medical Board (which became the NSW Medical Council) did not become aware of the American board’s action against Dr Reid until 2006 after a complaint from an Australian patient, the Medical Council advised the Newcastle Herald in a statement.
The NSW Medical Council said it was “actively monitoring” Dr Reid after questions from the Newcastle Herald about the “vaginal ageing” promotions.
Dr Reid did not respond to questions.
http://www.theherald.com.au/story/3986721/state-health-watchdog-cops-steep-rise-in-doctor-complaints-poll/
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