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Ethicon Media Monitoring 3/5/2018
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Women are cannon fodder in the mesh implant disaster, says Spanish doctor
Mar 5, 2018 | Cambs Time
By Kath Sansom
A Spanish doctor has hit out at vaginal mesh kits saying women have been used as human cannon fodder in a product that was mass launched with barely any safety trials. -
V-juvenated! The new £3,500 treatment that has changed my life
Mar 5, 2018 | The Times
By Kate Thomas
... Not everyone likes it, however. Most gynaecologists, wary after the recent debacle over the use of surgical mesh to treat prolapses in the vagina, take the view that there are no randomised controlled trials around ThermiVa and MonaLisa Touch, and are concerned about potential future problems. -
Retrain Your Bladder
Mar 2, 2018 | Chicago Health
By Morgan Lord
... If you aren’t planning any future pregnancies and are living with stress incontinence, bladder sling surgery has a 90 percent success rate. In this 10-minute, minimally invasive outpatient procedure, mesh is inserted under the urethra for support. -
New way to repair ravages of childbirth
Mar 5, 2018 | InDaily
... Current treatment options for POP are limited. Up until recently, many Australian women with POP underwent surgical insertion of transvaginal mesh implants – synthetic strips of materials that sit between a prolapsed organ (bladder, bowel and uterus) and the vaginal walls to hold the organ in place.
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Women are cannon fodder in the mesh implant disaster, says Spanish doctor
Mar 5, 2018 | Cambs Time
By Kath Sansom
A Spanish doctor has hit out at vaginal mesh kits saying women have been used as human cannon fodder in a product that was mass launched with barely any safety trials.
Juan Gervas joined the global debate saying women are mocked and ignored when they present with pain and says mesh kits are a prime example of misogyny in medicine.
Mesh is a problem in Spain too, he said, but in 2014 the Government ordered they must not be used as the first option and only after other treatments had failed.
Retired GP and visiting professor of Public Health, Dr Gérvas, said: “Women are the cannon fodder of a medicine that gets mad at them, that abuses on the basis of gender and that makes a mockery of their suffering.
“There is contempt for women’s problems and of underestimation of damages.
“Mesh kits were approved in a limbo about the real impact on patients’ lives. Its is an example of physician arrogance and disdain for females.
“My view is that they should never have been approved and never marketed. They have very weak scientific base, with short term studies generally supported by industry.”
And he added that documents prove the industrial and medical “recklessness” and of abuse and derision of women.
“For example, at Johnson & Johnson anal sex was proposed as an alternative to vaginal problems, and such advice was given by doctors to patients.
“What it suggests is that a woman is nothing but a receptacle to satisfy men.
“Advice of this style reflects part of the scorn with which the problem was despised, typical of the machismo of many gynaecologists and urologists of both sexes.”
And on the UK Government decision to not consider a suspension, the retired Madrid medic said: “The right decision should be to ban mesh implants, UK should join New Zealand.
“They need to look at studies that show mesh can shrink and degrade.”
There is currently talk of a “new mesh” being trialled at Sheffield University where researchers are developing a material made of polyurethane.
But Dr Gervas said: “This product should never marketed without appropriate testing. The Government will repeat history with polyurethane mesh, read carefully the press report from the university, as an example of hype.”
Until now the work is just experimental, with artificial tissue, in chicken embryos, not even in animals, he said.
“Women’s perineum are a very important anatomic region, as is the vagina, and merits a careful approach when having medical problems,” he added.
“We need randomised clinical trials of enough size and duration to test the best answers with follow up studies to be sure it works in the real world.”
Episiotomies, the daily bread of birthing rooms, is causing more harm than good, he added, and questioned their validity in vaginal birth as he said it could cause greater long term risks of women suffering SUI or prolapse in later life.
http://www.cambstimes.co.uk/news/mesh-kits-misogyny-dr-juan-gervais-1-5417984
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V-juvenated! The new £3,500 treatment that has changed my life
Mar 5, 2018 | The Times
By Kate Thomas
She’s had two children and has hit the menopause with all its discomforts. Here, Kate Thomas, 50, describes what happened on a visit to a leading gynaecologist
Tania Adib is chatting away, practical and relaxed, as if all this were perfectly normal. But then for her it is. She’s a gynaecologist. I’m sitting opposite her in one of those chairs with my legs up and apart and my pants off, feeling all sorts of awkward. Yes, I’ve had smear tests, but I have never been to a gynaecologist before, let alone one who is going to have a go at rejuvenating my vagina with a long, slim probe.
The only thing protecting my modesty is a small towel draped across my lower tummy. Oddly it helps, because I don’t have to watch her burrowing about in my denuded pubic area — shaved this morning because the treatment demands it and I hadn’t booked into my local waxing parlour in time. Who knew it would be back-to-back with Hollywood waxes on a Monday? But I digress.
Adib is tall, composed and smartly dressed, with long tawny hair and a low-key, respectful manner. As a consultant gynaecologist working privately (the Lister) and in the National Health Service (Queen’s Hospital, east London), she specialises in treating gynaecological cancers and the menopause and sits on the board of the Breast Cancer Haven charity.
She explains that the probe machine, the ThermiVa, uses radio frequency, a kind of energy derived from radio waves. It will heat up the skin tissues lining the vagina to 45C or 46C, enough to make the collagen in those tissues contract and tighten. It will also make the walls of the vagina grow new collagen and elastin to make them strong and springy and improve the blood supply and production of the vaginal fluid without which sex, post-menopause, can be so painful. She’s mainly using it on menopausal women and says it’s great for vaginal dryness and mild stress incontinence, but that it’s also great for younger women to counteract the stretching during childbirth. In either case, it’s restoring vaginal health.
My mind is buzzing with anxiety and barely takes all this in as Adib picks up a long white probe, which is attached by a cable to a tall machine at my side. She asks her nurse for a huge syringe of conductive gel, squirts it neatly inside me, gently inserts the probe and starts to move it carefully and methodically around.
I brace myself to wince, but it feels like . . . nothing. But then I can’t feel much on my insides, and that’s one of the reasons I’m here. That and my pelvic floor, which lets me down now and then, as it did in a boxing class the other day. We had to skip with ropes, bouncing with both feet together, and I barely realised what was going to happen before I sprang a leak.
When I told this to my friend Jo, she said I should see Adib. Jo has a job that means she’s up to speed on all the latest procedures and she’s had ThermiVa — of course she has. And she rates it. She has shocked me in the past with talk of the “designer-vagina” trend and the labia trimming and hymen rebuilding that goes with it, and I’ve tut-tutted. Who would do that? What kind of cultural pornification has taken place that women feel their lady parts have to conform to some plastic ideal?
But what’s going to be really huge, Jo tells me, is non-surgical “intimate rejuvenation”, as it is coyly called. Things such as this ThermiVa, which tightens everything up, including your pelvic floor, improves your sex life, takes less than an hour and doesn’t hurt. She says that half the Botox clinics in London are offering it — discreetly, because it’s a bit of a leap from wanting to soften your wrinkles to deciding to get your ya-ya lasered — and that at the sort of conferences she goes to every brand that makes machines that de-age the face now has something to offer for the vulvo-vaginal region.
I want to denounce this as disturbing, but I’m intrigued, if confused. Is this intimate “work” being done for aesthetic reasons or for improved v-health? And do you really want a Botox nurse zapping your hooty-hoo? At any rate, I’m glad I’m in Adib’s gynaecologically trained hands. She does the treatment at a cosmetic clinic too, although it’s one of the smartest: the slickly designed Mallucci London, tucked away in a cul-de-sac off Brompton Cross, in Kensington, London.
I couldn’t care about the aesthetics of my undercarriage, but then I’m 50, tipping into the menopause and my husband, bless him, really doesn’t care what my downstairs looks like as long as he can gain regular access. But treating vaginal laxity — that’s the technical term for looseness — sounds interesting. Way back when, nearly 20 years ago, I had two enormous babies, which must have stretched everything out, I have never been able to forget one of Martin Amis’s characters [in The Rachel Papers] describing sex with a woman who has given birth as like “waving a flag in space”. My husband nobly says it’s not, but I bet it is.
Adib tells me I have only a mild degree of laxity, not a patch on some of the women who seek her help. Her background is as a consultant in gynaecological cancer and the surgery that goes with it, and that has made her concerned about the knock-on effects of menopause, which the surgery would often bring on, sometimes suddenly.
“We cure women of cancer, but it is the long-term effects that they have to cope with,” she says. “Women who have had breast cancer also struggle with vaginal dryness, and this is a great treatment for them. Other women choose not to have hormone replacement therapy for other reasons, but want an effective and reliable treatment for vaginal dryness, which unfortunately tends to get worse with time.”
She set up a menopause service for her patients, looking at what could be done to help through diet, mindfulness, juicing and sprouting — “I’m half-German,” she says, laughing; “I like all that complementary stuff” — and at a gynaecological conference two years ago spotted a laser device offering non-hormonal treatment of vaginal dryness, with decent scientific data to validate its effectiveness. This was — don’t snigger — MonaLisa Touch, a laser device that she still uses for treating vaginal atrophy, the dryness that sets in once the body’s supply of oestrogen dries up at menopause.
When she started consulting at Mallucci London last year the clinic suggested she use the ThermiVa. “So I got trained and I just love it,” she says. “The laser is great for atrophy, but radiofrequency is better for laxity and fantastic for atrophy too.”
After that first session I spend the rest of the day in a shaky daze. Not because anything hurt; I just can’t believe I have done this. But I am cautiously hopeful because it feels as if something has been suctioned back up inside me.
Actually I know there is shrinkage because zapping the vulva — that’s everything on the outside of the vagina — is part of the treatment, and Adib took pictures of my labia before and after (I can’t believe I just typed that, and no I don’t have a copy on my phone. Nor does she — they’re hidden on an encrypted area of her iPad). It did feel a bit hot as she skated the probe around, but she turned down the temperature until it was bearable. “But look at the difference,” she said enthusiastically. I wanted to shut my eyes — this is all so . . . very unusual — but could see that the loose flappy bits had shrunk and neatened. “Yes,” she said, “and that is what will have happened on the inside too.”
Good grief. Can this machine do this on the face? It would clean up! Up to a point, she told me. The face tissues aren’t hanging so loose.
A month later I return for a second session. Adib asks how I’ve felt and, well, I’m not sure what is different during sex, nor is my husband. I didn’t tell him that I’d had a treatment until he asked when I was going to go and I said I’d already been. Then he claimed he could tell. Hmm. “That’s quite typical of men,” Adib says.
But I’ve been skipping secretly in the kitchen and I can get up to 40 bounces before my pelvic floor feels the stress, so something must be happening.
How does it work on the pelvic floor? Actually, Adib tells me, it doesn’t, because the pelvic floor is muscle, But ThermiVa works on the soft tissues of the vagina and strengthens and supports them — tightens them, makes more collagen and elastin, grows more blood vessels — in a way that no exercise is going to do, and that is what helps to fix stress incontinence and that sort of urgency to wee that can affect many post-menopausal women. Do your pelvic floor exercises, the good old pull-up-and-hold sort that are taught to mums-to-be, alongside treatment and you’ll be laughing, even if you sneeze.
But by the third session — for best results you need a course of three treatments, each a month apart, to boost that growth of collagen and all the rest — I can tell there is a definite change going on inside me. Sex is less flag-in-space; more of a snug fit. My pelvic floor feels as if it has, as one of Adib’s other patients put it, “gone up a floor in the lift”.
I like Adib enormously and am thrilled by the way she gets fired up when she talks of her crusade to improve our v-parts and all the issues that we are too embarrassed to discuss. “I know lots of aesthetic clinics are using it,” she says, “but it’s actually about improving vaginal function. Vaginas are not just passive organs; they’re very dynamic. They contract when you become sexually aroused, they produce secretions, and the health of the vagina determines the health of the bladder and the bowel. When you get vaginal atrophy, you get dryness, discomfort, itching, burning, recurrent vaginal infections and urine infections. Maintaining the health of the vagina is underrated and it’s so important for women’s sexual and general wellbeing.”
She and her magic wands are at the forefront of this new wave of treatments and the buzz around them is building. Tatler has mentioned her work, although most patients simply arrive by word-of-mouth recommendation. “I haven’t had anyone who hasn’t been delighted,” she says.
Not everyone likes it, however. Most gynaecologists, wary after the recent debacle over the use of surgical mesh to treat prolapses in the vagina, take the view that there are no randomised controlled trials around ThermiVa and MonaLisa Touch, and are concerned about potential future problems.
“There is no evidence to suggest that non-surgical devices are effective in improving vaginal muscle tone or treating vaginal dryness,” says Dr Vanessa Mackay, a spokeswoman for the Royal College of Obstetricians and Gynaecologists. “If women are concerned about the appearance or feel of their vagina, they should speak to a healthcare professional.”
Yet those who use it and have tried it love it. Certainly the reviews on RealSelf, a US-based website where people post queries about surgical and non-surgical procedures, are largely ecstatic. (Watch out, if you are moved to take a look. The pictures are graphic. Labia, I now realise, come in every shape and size.) I also read with interest that there is a study showing that this treatment can help women who can’t reach orgasm. Maybe by reviving nerves in the vulvo-vaginal area. And as for my own? Maybe it’s suggestion, maybe it’s for real, but they’re better. It’s a bit, I thought while watching the Winter Olympics, like a ski jump. Sometimes you barely make it to the lip of the jump and just subside. But other times you take off and soar. Well, I’m soaring.
For Adib this is the tip of the iceberg. She’s championing women’s sexual function and enjoyment into their old age. “That’s what I really want to see,” she says. “That women can have a satisfying sex life way into their seventies and eighties. And it is treatments like this that will enable that.
“There’s a big regenerative movement coming. Medicine is moving on. It’s so exciting. No longer does it have to be just drugs or surgery — there’s all this other stuff.”
For now there’s laser and radio frequency treatment, which needs a top-up each year to stay effective, but she’s also about to be trained in how to inject the vagina with cells taken from a patient’s fat. It’s a one-off treatment and she will be the first to offer it. I’m fine for now, thanks, but in due course? I’ll be first in line.
ThermiVa with Tania Adib costs £3,500 including gynaecological consultation, smear, scan and six-month review at mallucci-london.com
The writer’s name has been changed -
Mar 2, 2018 | Chicago Health
By Morgan Lord
Don’t let urinary incontinence dampen your lifeIf you’ve experienced some form of urinary incontinence — the accidental release of urine — you are not alone. It’s an issue that affects 25 million people in the U.S., according to the National Association for Continence. And if you’re a woman, it’s twice as likely to be an issue, according to the U.S. Department of Health and Human Services.
“This is a huge women’s health concern,” says Kimberly Kenton, MD, chief of urogynecology at Northwestern Medicine and director of the Women’s Integrated Pelvic Health Program at Northwestern Medicine. “Urinary incontinence typically starts for women in the reproductive years. After pregnancy and a vaginal delivery, there’s a 30 percent increase in urinary incontinence for women.”
The increase in urinary incontinence after pregnancy makes sense given the pressure the uterus puts on the bladder, Kenton says. Then, when giving birth, pelvic muscles can become stretched and weakened, and nerves can be damaged.Got to go
Even if you’ve sailed through childbirth without an issue, urinary incontinence can creep up on you with age. By 40, urinary incontinence affects 30 to 50 percent of childbearing women, according to the National Association for Continence. By the time women are in their 60s, about two-thirds suffer some form of incontinence, Kenton says.
There are two main types of incontinence: stress and urge. Stress incontinence occurs when a physical movement — like coughing, lifting or running — exerts force on your bladder, causing urine leakage.
Urge incontinence — also called over- active bladder — is the strong, sudden urge to pee at inappropriate times, such as when you hear the sound of water, experience a temperature change or even turn the keys to unlock your front door.
“When it comes to urinary inconti- nence, severity is truly personal — it’s all about how much the leaking is bothering the individual woman,” Kenton says. “No amount of incontinence is normal, but it’s also not life-threatening. And there are plenty of solutions.”Addressing incontinence
Pelvic floor exercises (or Kegel exercises), which involve repeatedly contracting and relaxing the pelvic floor muscles, can help. But, Kenton says, seeking the guidance of a physical therapist can be even more advantageous. After all, some muscles may need lengthening, some stretching and some tightening.
A physical therapist assesses what’s going on with your pelvic floor muscles and shows you the exercises needed to help the muscles support the bladder and help the body regain control of leakage, spasms and urine stream.
If your leakage is persistent, the tried-and-true pessary — a removable plastic device — can be placed in the vagina like a tampon during the day or during a strenuous activity and taken out at night. Its purpose is to support the neck of the bladder and help prevent leakage.
If you aren’t planning any future pregnancies and are living with stress incontinence, bladder sling surgery has a 90 percent success rate. In this 10-minute, minimally invasive outpatient procedure, mesh is inserted under the urethra for support. Patients can return to full activities the next day, Kenton says.
A slew of bladder medications address urinary incontinence. The largest class, anticholinergic drugs, work to counter overactive bladder. The drugs block the chemical messenger — acetylcholine — that sends signals to the brain to trigger abnormal bladder contractions. Popping these pills can come with side effects including dry mouth, dry eyes and constipation.
For urge incontinence, there’s Botox for the bladder, which results in few side effects and no leakage for six to 12 months. There’s also the option to surgically implant a small device into the sacral nerves that emits electrical pulses that communicate with the brain and bladder. This FDA-approved “pacemaker for bladder” can reduce urinary leaking and urgency, Kenton says.Bladder training
And then there is bladder training, a form of behavior modification.
“Thankfully, any bladder that has some form of dysfunction — whether it’s not emptying enough or it’s emptying too much — can be retrained,” says Alan Y. Sadah, MD, urogynecologist at West Suburban Medical Center. “Bladders are malleable, like a thermostat. They sometimes need to be recalibrated or retrained.”
In some cases, such as when an individual is experiencing urge inconti- nence, has dementia or when the impulse to empty isn’t received, timed voiding can help. Timed voiding means that the bladder is emptied on a regular basis, like every hour on the hour — not only when the urge to void is felt.
“Now instead of the bladder being in control, the individual is,” Sadah says. “Bladders can be retrained. It just takes a plan and some time.”“By 40, urinary incontinence affects 30 to 50 percent of childbearing women. By the time women are in their 60s, about two-thirds suffer some form of incontinence.”
Retraining her bladder was necessary for Katy Groves, 41, of Oak Park. After delivering her baby one year ago, her bladder was temporarily paralyzed, possibly due to an epidural during childbirth. Sadah describes this as the bladder going into hibernation, or sleep mode, and says this can happen when anesthetized, such as with an epidural or hysterectomy.
Over the next few months, Groves learned to use a variety of catheters, went to physical therapy and acupunctureand used timed voiding to help get her bladder out of sleep mode and back in working order.
“After a vaginal delivery, you need to learn to reuse your pelvic floor muscles,” says Margaret G. Mueller, MD, urogynecologist at Northwestern Medicine. Pelvic floor symptoms, such as urinary difficulties, perineal pain and pelvic pain, can be common post-delivery. Seeing a physical therapist can help, she says.
Mueller and Kenton are part of Northwestern Medicine’s PEAPOD (Peripartum Evaluation and Assessment of the Pelvic Floor around Delivery) clinic, a program for new mothers who experience pelvic floor symptoms.
Urinary incontinence doesn’t have to be a thing that just happens to you. You should be able to run, sneeze and unlock your front door without fear
of leakage. On average, women wait over six years from the first time they experience symptoms until they obtain a diagnosis for their bladder control problems, according to National Association for Continence.
Instead, think like a bladder and act with urgency. Make it your number one priority — pun intended. There are revolutionary solutions and techniques to help your bladder now.
https://chicagohealthonline.com/urinary-incontinence/
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New way to repair ravages of childbirth
Mar 5, 2018 | InDaily
Nanotechnology and bioengineering are helping medical scientists develop stem cell therapies for a debilitating condition which can follow childbirth.
They are combining stem cells from the lining of a woman’s own uterus with nano-biomaterials – or biodegradable materials engineered on the nanoscale – in a world-first approach to develop safer, more effective treatments for pelvic organ prolapse.
Pelvic organ prolapse (POP) is a lifelong sometimes debilitating condition, usually caused by the impact of childbirth. It affects an estimated one in four women and around one in two women aged over 50.
Up to a third of women with POP require multiple treatments in their lifetime.
Seven years in the making, the multi-disciplinary project includes collaborators from the Ritchie Centre at Hudson Institute, Flinders University, CSIRO, the Monash Institute of Medical Engineering and Associate Professor Anna Rosamilia, head of the Pelvic Floor Unit at Monash Health.
Project leader Professor Caroline Gargett, from the Endometrial Stem Cell Biology group at the Hudson Institute of Medical Research, says the ultimate aim is to restore quality of life to women with POP, and to prevent the condition from occurring in younger women.
“We know that women and clinicians are calling out for safer, more effective treatments and we are working to deliver these options,” she says.
“We have shown in preclinical studies that endometrial stem cells differentiate into the type of cells that are required in the vaginal walls.
“We believe endometrial stem cells have real potential in treating pelvic organ prolapse. The cells have been shown to produce factors that ‘trick’ the body or modify the immune response to one of healing, rather than scarring, which helps to repair the damage.”
POP develops when tissues, pelvic floor muscles and ligaments that support the pelvic organs (bladder, uterus and bowel), become damaged, usually in childbirth, causing organs to shift or ‘drop’ into the vagina or even outside the body.
This can lead to debilitating symptoms, including poor bladder or bowel control and pain during sex. This may profoundly affect a woman’s quality of life.
POP may be exacerbated by other factors such as age, ethnicity, the number of times a woman has given birth, obesity and their family genetics.
It is exacerbated by menopause – one in two postmenopausal women who have had children will experience POP, compared to one in four women generally.
At Flinders University, Professor John Arkwright’s laboratory at Tonsley is developing a novel fibre optic probe to better monitor and classify damage to the pelvic floor region.
The Flinders researchers are developing a fibre-optic pressure device to help develop a method to more accurately diagnose areas of weakness associated with POP and better target stem cell treatments to those areas.
“Accurate diagnosis of the areas of weakness associated with POP will better manage the new treatment method,” Arkwright says.
Clinical trials are not expected for at least another three to five years. Before the treatment can reach women, it must first undergo a rigorous process of preclinical testing to show long-term safety and efficacy, as well as research ethics and Therapeutic Goods Administration approvals.
Current treatment options for POP are limited. Up until recently, many Australian women with POP underwent surgical insertion of transvaginal mesh implants – synthetic strips of materials that sit between a prolapsed organ (bladder, bowel and uterus) and the vaginal walls to hold the organ in place.
Around the world, safety concerns have been raised around these meshes due to reports of adverse effects in women such as pain, scarring and organ perforation.
The Therapeutic Goods Administration in Australia conducted a review of the scientific evidence and clinical studies of transvaginal mesh products for POP, and found the benefits of these meshes do not outweigh the risks to patients.
In November 2017, the Therapeutic Goods Administration announced it would remove transvaginal mesh products for the sole purpose of treating pelvic organ prolapse via transvaginal implantation from the Australian Register of Therapeutic Goods.
A class action is also underway on behalf of around 700 Australian women who are seeking redress for adverse effects they claim have occurred as a result of transvaginal mesh implants.
A Senate Enquiry on the issue is expected to report on its findings on March 20, 2018.
https://indaily.com.au/news/local/2018/03/05/new-way-repair-ravages-childbirth/
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