Preview Newsletter
Ethicon Media Monitoring 5/18/2017
-
"At 19, I stopped going out because I was afraid I'd wet myself in public"
May 17, 2017 | Net Doctor
By Natalie Healey
If you feel a sudden urge to empty your bladder when you cough, sneeze, laugh or lift something, you are not alone. -
Does the FDA’s MAUDE Work?
May 17, 2017 | Mesh Medical Device Newsdesk
Printed on the website of Society of American Gastrointestsinal and Endoscopic Surgeons (SAGES),is an audit of the Food and Drug Administration’s (FDA) MAUDE database. -
Angel Flight May Help You
May 17, 2017 | Mesh Medical Device Newsdesk
Please be aware if you need transportation to a doctor who specializes in treating injuries resulting from your medical device, Angel Flight may be there to help.
Client Attorney Privileged/Attorney Work Product/At Request of Counsel
Online Sources
-
"At 19, I stopped going out because I was afraid I'd wet myself in public"
May 17, 2017 | Net Doctor
By Natalie Healey
If you feel a sudden urge to empty your bladder when you cough, sneeze, laugh or lift something, you are not alone. 1 in 3 women suffer from some form of bladder weakness in the UK, making it more common than hay fever. But many of us believe it is a taboo subject that should not be discussed with friends and family.
Fitness and pelvic floor expert Jane Wake is determined to change this attitude because it's putting our mental and physical health at risk. And it's a curiously British problem. She reveals that in France, women automatically get physiotherapy to treat any issues associated with bladder weakness after childbirth.
"It's just an open fact that is out there and generally talked about. Women from other countries have told me that it's just something that you know – it is passed down from one generation to women to another: "you do your pelvic floor exercises or else!."
But most of us don't even know what the pelvic floor is, let alone how it works and what you can do to prevent issues later. And many wrongly assume incontinence only happens to older women. It's just not true.Pregnancy and the pelvic floor
While pregnancy might feel like a magical time for a lot of women, there can be several unwelcome changes too. A growing baby can place a lot of stress on your pelvic floor muscles. And hormonal changes, pressure on the bladder from an expanding womb, and of course, the trauma of labour itself can weaken the pelvic floor further and result in urinary leaks.
It's something 24-year-old Stephanie from East Sussex is all too aware of. She started having issues at just 19 years old after giving birth to her first son.
"Before I had my children, I was perfectly fine and in good health. Nothing was wrong at all. I got pregnant with my first son when I was eighteen. I was 19 when I had him and it was after the pregnancy that my problems started. I had a four day labour and I had put on quite a lot of weight during the pregnancy which probably didn't help."
It was after the birth that the incontinence started. But embarrassed with a condition she felt she was too young to have, Stephanie avoided seeking help for almost two years.
"I'd go to the doctors but the GP I had at the time wasn't the best at dealing with it. They didn't come up with many solutions other than "do your pelvic floor exercises", but I really was doing them at the time and it just wasn't helping. So a lot of time passed and I went back to my GP – but this time I had a new doctor. She referred me to a physiotherapist who did an internal exam."
It was during this examination that Stephanie was told her pelvic floor muscles were so weak it wouldn't matter how many exercises she did now. She'd likely need surgery, in the form of a vaginal mesh implant – a controversial procedure which has been in the news recently because of the number of women who claim painful permanent side effects have been caused by these devices.
The psychological toll
The problem had taken its toll on Stephanie psychologically and she barely left her home. She ended up talking herself out of social situations, and avoiding outside games with her son.
"If I did go out, I would always wear a long top to make sure it covered my bottom just in case. You're always conscious that it could happen at any point. I had a particularly embarrassing situation when I went to park with my son and my friend and her little boy. And somebody threw a ball over. I stood up to go and get it, but I stood up too quickly and ended up wetting myself in the park. It meant I stopped going out because I didn't want to put myself in an awkward situation."
Stephanie tried to get around the problem by limiting her fluid intake. But that caused more damage. Because she wasn't drinking enough, her bladder wasn't emptying properly.
Jane believes fewer women would be in Stephanie's situation if we were better talking about women's health.
"What we don't realise is that by being so 'stiff upper lip' about it, we are creating a stigma. We need to be openly more positive about it and get women to realise that if you have incontinence issues, you absolutely can do something about it. By strengthening the pelvic floor and focussing on muscle balance, women can tackle the cause of the issue rather than just managing their symptoms – pads do not have to be the answer."What is the pelvic floor anyway?
Jane calls the pelvic floor muscle our body's biggest unsung heroes. By strengthening the floor and maintaining muscle balance, women and men can treat the cause of leakage, rather than just managing the symptoms, she says.
It's worth practicing pelvic floor exercises as soon as you can. But Jane admits that they can be difficult to master. While Stephanie points out that it's easy to forget to do your Kegels if you're worrying about a new arrival.
"They don't teach you to do pelvic floor exercises in high school. You just think incontinence is something that won't ever affect you. It was only when I was pregnant that my midwife first mentioned that pelvic floor exercises were something I should be doing. But it's so easily the last thing on your mind when you've unwell with morning sickness. It gets put on the back burner."
Innovotherapy
But while Stephanie was waiting for surgery, an alternative was offered to her by doctors. She was asked if she wanted to enroll in the clinical trial for a new non-invasive device that could strengthen her pelvic floor within going under the knife. She agreed. The machine called Innovo (which currently retails at £249.99) sends targeted impulses to safely activate all the muscle of the pelvic floor. You put it on like a pair of shorts and use a handhold switch to control the impulses. After trying it for half an hour a day for a few weeks, Stephanie felt sure she was seeing an improvement. Within a few months, Stephanie felt back to her old self.
She says: "The machine completely changed my quality of life. If I can stop just one more woman suffering in silence, I know I've done the right thing by talking about it."
Jane's tips for a stronger pelvic floor
1. Visualise the floor
The pelvic floor is a group of muscles that attach to your tailbone at the back and your pubic bone at the front. Think of it like a hammock strung between these two points. It also attaches to the sit bones - these are the bones at the base of the pelvis - if you are seated now, grab a hold of your butt cheek, pull it out the way and then feel the bone underneath - these are your sit bones.
2. Think about farts
Imagine pulling the sides of your hammock out and attaching it to these two points - you end up with a diamond shape base to your pelvis - this is our pelvic floor. We are often told to connect to it by thinking about stopping a wee. A better way is to first of all imagine stopping a fart from your back passage, then stopping a wee from the front then pulling these two points in and up together. If you also imagine drawing the sit bones in from the sides, you'll get a deeper more thorough contraction of the pelvic floor. Doing this before you have issues will mean you are able to connect to it better when and if you do get problems.
3. Lift it up
A healthy muscle however is one that not only has good strength but also length and balance. So as well as pulling the muscle up you have to think about letting it relax - a good way to do this is to imagine pulling it up through 5 floors - like a lift going up. Always go back down through the floors before you lift up again.
http://www.netdoctor.co.uk/healthy-living/wellbeing/a28201/incontinence-after-baby-pregnancy/
-
May 17, 2017 | Mesh Medical Device Newsdesk
Printed on the website of Society of American Gastrointestsinal and Endoscopic Surgeons (SAGES),is an audit of the Food and Drug Administration’s (FDA) MAUDE database.
The Inadequacy of MAUDE review is from the St. Louis, MO Washington University School of Medicine aimed at testing the limits of the Food and Drug Administration’s database on adverse event reports.
MAUDE, (Manufacturer and User Facility Device Experience) collects reports on complications that come in from patients, attorneys, hospitals, and device users like hospitals.
As we’ve reported, often those reports are first sent to the manufacturer for evaluation. In some cases, the manufacturer discounts that a complication is device-related and that event may never be sent to MAUDE.
So its accuracy is of critical importance.
Washington University surgical resident Dr. Shuddhadeb Ray, MD and others wanted to find out the reports that appeared on MAUDE for abdominal wall hernia repair done at Wash U.
Medical records were reviewed from their high-volume tertiary academic surgical center in St. Louis during a seven-year period. Included in the number of hernia surgeries was the date, age, BMI, sex, ASA score, the location of the hernia, previous surgeries, previous hernia repairs, the defect size, mesh size, mesh type, operating time, hernia recurrence, and mesh-related adverse events.
In all, there were 2298 patients with an average of 55 + who underwent incisional, umbilical, apigastric, Spigelian and lumbar hernia repair. Failures included mesh failure, suture retention failure, mesh fragmentation, degradation, and erosions/adhesions needing bowel resection.
Checking with MAUDE, over the same time period using date of operation and type of mesh, for any operative reports and researchers found, “No mesh-related adverse events at the surgical institution were identified within the MAUDE database after audit of all applicable reports (n=4135).”
This leaves one with the conclusion that complication reports are not making it to what is supposed to be the most reliable reporting system for the FDA. Researchers conclude the MAUDE database is not providing an accurate representation of mesh-related adverse events or trends. They suggest a national centralized system to track the mesh-related complications.
http://www.meshmedicaldevicenewsdesk.com/fdas-maude-work/
-
May 17, 2017 | Mesh Medical Device Newsdesk
Please be aware if you need transportation to a doctor who specializes in treating injuries resulting from your medical device, Angel Flight may be there to help.
Angel Flight West is a nonprofit organization that arranges air travel for those with serious medical conditions. There are 1,400 pilots located in 13 western states who donate their time, airplane, piloting skill and all costs to the families in need. Reach out to them at 888-426-2643. Here is their website.
http://www.angelflightwest.org/Listen to this message from USAir hero pilot “Sully”!
http://www.meshmedicaldevicenewsdesk.com/angel-flights-may-help/
Client Attorney Privileged/Attorney Work Product/At Request of Counsel
Online Sources
Add recipients
Suggested