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Ethicon Media Monitoring 2/8/2019
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Why Medical Implants Like Surgical Mesh Are Facing Tighter Safety Regulations From The FDA
Feb 7, 2019 | Nashville Public Radio
By Blake Farmer
There's no doubt that surgically implanted devices improve lives — drug pumps, nerve stimulators, spinal rods. But the devices can also do serious damage, like they have to Mechel Keel. -
Women Resort To Vaginal Mesh Implants Removal Within A Decade
Feb 8, 2019 | ZMR Marker Journal
By Francis Bynum
A new study has suggested the women in England having vaginal mesh implants for incontinence treatment will have to reverse the undergone procedure. -
12 'Taboo' Symptoms of Ehlers-Danlos Syndrome
Feb 7, 2019 | Yahoo News
By Cassidy Colbert
When many people talk about Ehlers-Danlos syndrome, the symptoms they often focus on are hypermobile joints and elastic, velvety skin.
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Why Medical Implants Like Surgical Mesh Are Facing Tighter Safety Regulations From The FDA
Feb 7, 2019 | Nashville Public Radio
By Blake Farmer
There's no doubt that surgically implanted devices improve lives — drug pumps, nerve stimulators, spinal rods. But the devices can also do serious damage, like they have to Mechel Keel.
"It ruined my life, yes it did. I'm sitting here with tears," the 59-year-old grandmother says.
To stop bladder leakage, a doctor in Columbia recommended stitching a flexible mesh strap inside her pelvis. She agreed to the procedure but says the mesh never felt right. And it hardened and started cutting her insides — a scenario that's played out a thousand times over around the world.
The pain kept her from returning to her job as a hairdresser. A decade later, living in mid-Michigan, removing all the bits and pieces from the scar tissue has required multiple surgeries and resulted in chronic infections. Keel can see why her doctor in Tennessee thought the high-tech mesh would help. But she also now feels like she was "a guinea pig."
"We were the testers," she says. "There was no animal testing done. We were the animals."
More and more ailments are being treated these days with implants. And most of these medical devices, unlike pills in a medicine cabinet, don't go through human testing before being offered to patients. But many devices have been breaking down in people’s bodies, and reports about sometimes debilitating injuries are forcing the Food and Drug Administration to revamp the approval process, which is green lighting an average of a dozen new devices a day.
For devices in which failure is obviously life threatening, regulators have required some sort of human testing as part of the most stringent path — known as Pre-Market Approval. But most medical devices enter through a side door. And the FDA now acknowledges that even some seemingly harmless, inert devices have caused major problems.
"We have things like metal-on-metal hips," says medical author Jeanne Lenzer. "Outside the body, seem to function just fine. They put them in little machines, rack them back and forth, they don't break. [But] put them inside people, and something very different happens."
For example, little shards of cobalt from the joint have leached into the bloodstream of some patients and caused dementia-like symptoms, forcing a massive recall. Lenzer just wrote a scathing book titled "The Danger Within Us" about the device industry and says she was "dumbfounded" to find out how many devices never went through human testing like drugs do.
That's in part due to an expedited approval process known as 510(k). It allows manufacturers to bypass many requirements by showing their product has "substantial equivalence" to a "predicate device" already approved for use.
"You just say your device is like an old device, and the old device was never tested nor was your device," Lenzer says.
In practice, sometimes the basis for a whole family tree of devices turns out to be defective. Pelvic mesh is a good example, with much of what's on the market being based on mesh that was around prior to FDA regulations for medical devices. One study found that 16 percent of mesh on the market was based on products that had been pulled from the market over safety concerns.
The FDA has paid special attention to problems with mesh and even started requiring human testing for some products in recent years. The agency will hold an advisory committee meeting next week to discuss the safety and effectiveness of mesh.
Manufacturers have pushed back against calls to bring regulation of medical devices in line with medication. Scott Whitaker, CEO of AdvaMed, speaks for industry giants like Stryker, Johnson & Johnson and Medtronic, dismissing the idea that devices — which range from a tongue depressor to surgical robots — should all go through human trials.
"Testing should be as complete and as thorough and as ethical and as appropriate as possible," Whitaker tells WPLN. "But it doesn't all fit the same and can't all fit the same standard. Not every surgery to treat the same condition goes exactly the same way every time."
The FDA declined a request for an interview but has released some written justification for the regulatory revamp.
"We believe firmly in the merits of the 510(k) process," FDA commissioner Scott Gottlieb said in a November statement, noting that applications have doubled in size to an average of 1,100 pages. "But we also believe that framework needs to be modernized to reflect advances in technology, safety and the capabilities of a new generation of medical devices."
In the same statement, the agency confronted some specific shortcomings and charted plans to make changes to the process over the next few months: Pushing back on manufacturers that base any new device on one that's more than 10 years old More actively watching how devices perform once they're on the market rather than relying on patients to report problems Scrapping the 510(k) name for the something more descriptive, the "Safety and Performance Based Pathway"
Michael Matheny, a professor who tracks medical devices at Vanderbilt University, approves of the FDA’s incremental approach, and calls it thoughtful. He says he wouldn’t want changes to spark hysteria over high-profile device failures.
"It would really be unfortunate if patients wouldn't consider any medical devices at all to be used in their bodies," Matheny says. "But I do think being aware that there's nothing without risk is also important."
Matheny notes, though, that in some ways the risks are more profound than with medication. If the FDA recalls pills, a patient can at least stop taking them immediately. With devices, they're sort of stuck with it, at least for a while — and that's if a surgeon can even safely remove it.
https://www.nashvillepublicradio.org/post/why-medical-implants-surgical-mesh-are-facing-tighter-safety-regulations-fda#stream/0
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Women Resort To Vaginal Mesh Implants Removal Within A Decade
Feb 8, 2019 | ZMR Marker Journal
By Francis Bynum
A new study has suggested the women in England having vaginal mesh implants for incontinence treatment will have to reverse the undergone procedure. About 3.3% of the women required the implants to be taken out just within 10 Years. According to the NHS, this a third largest requirement for reversal of the procedure.
The complications of the mesh in the younger women were almost 4.4%. The London School of Hygiene and Tropical Medicine researchers have found that the vaginal mesh implants had to be removed in 6.9% of the women but the reasons for such an action has not yet been reported. The Gynecologist Dr. Lucia Dolan has confirmed that most of her patients got the tape removed due to certain complications. The meshes are permanent and there is no temporary version still made available. The incontinence dealing patients will face the problem again after the removal of the mesh tapes. At some point in life, the women tend to face urinary incontinence and the mesh implants used to treat the problem has other side effects linked.
The lawsuits have now entered the legal sector as the mesh implants have shown to cause injuries in women across the UK, the US, and other regions. The deforming implants lacerated the soft tissues of the vaginal canal causing severe pain and disability. The NHS has made it clear that only in the last alternative cases will the implants be transplanted under stringent care. The procedure if done requires regular follow up for keeping side effects at bay. The mesh tapes were earlier used to treat organ prolapse after childbirth before being used for incontinence treatment but now this is also in question. Among 100,516 women, 2,639 mesh tape removals have taken place amid 2008 and 2017. The problem is not popular as a result of women lacking to come forward rather opting for other medication to ease the side effects. The Australia government had already apologized on a national ground to the thousands of women affected by the vaginal mesh scandal and also the pain and agony they had to go through. The mesh devices have already been banned and the further improvement steps are also been taken to help women.
https://zmrmarketjournal.com/772/women-resort-to-vaginal-mesh-implants-removal-within-a-decade/
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12 'Taboo' Symptoms of Ehlers-Danlos Syndrome
Feb 7, 2019 | Yahoo News
By Cassidy Colbert
When many people talk about Ehlers-Danlos syndrome, the symptoms they often focus on are hypermobile joints and elastic, velvety skin. However, since EDS is a connective tissue disease (and connective tissue is found throughout most of the body), the condition can cause a plethora of other symptoms – some of which may be considered “taboo,” and can be more difficult to talk about.
So if you’re experiencing unpleasant or even “embarrassing” symptoms, it may hard to discuss the details of what you’re going through with a doctor or trusted friend or family member. Talking about certain aspects of our health, like gastrointestinal issues, can often still feel awkward, or a bit “off-limits.” But you should never feel like you’re not supposed to talk about symptoms or side effects others may see as “taboo.” Even though they might be tough topics to bring up in conversation, it’s important we raise awareness of their effects so EDS-ers can feel more supported and understood.
Related: How Fantasy Books Helped Me Accept the Reality of My Chronic Illnesses
We asked our Mighty community to share the “taboo” symptoms of Ehlers-Danlos syndrome we don’t talk about, and what they wish others understood about these symptoms. Let us know if there are any other “taboo” symptoms we missed in the comments below.
Here is what our community shared with us:1. Urinary System Issues
“Bladder problems. Whether it’s peeing too much or not being able to pee at all. They’re both common for people with EDS but rarely talked about.” – Jessica T.
“Urethral diverticulum.” – Lizz R.
“Incontinence issues. I’m 26 and leak pee.” – Kari R.2. Skin That Bruises or Marks Easily
“The bruises!! I wake up with new ones every single day and it’s problematic.” – Biranna L.
“Stretch marks and scars. I don’t get ‘little’ scars or ‘little’ stretch marks. No matter what the issue mine are ginormous and look like welts.” – Josephine W.3. Difficulty Regulating Weight
“Being unable to lose or gain weight, depending on your body type. A lot of us cannot exercise or eat ‘normal’ diets, so losing or gaining weight is very difficult.” – Ashley B.4. Women’s Health Issues
“Exacerbation of the menstrual cycle and hormones. For me it’s a nightmare for [three and a half out of four] weeks of the month. ” – Courtney M.
“I don’t know what it is, but it feels like someone’s taking a garden rake and ripping my vagina to shreds every now and then. I’ve heard that it has to do with the vaginal connective tissues coming apart, but I’m not sure. I wish people knew that it is so excruciating and all you can do is sit there and hope to God it passes.” – Mikki I.
“Pelvic floor dysfunction – whether it’s urinary incontinence, vaginismus, prolapses, etc. Since it involves an intimate area [so] it can be hard to get support.” – Caroline M.
Related: When Your Invisible Disability Becomes Visible5. Prolapse
“Pelvic organ prolapse. It’s extremely common and women have no idea they have it and are just quietly dealing with the symptoms. I prolapsed in childhood and didn’t get diagnosed until I was 27 because I was too embarrassed to ask a doctor about it until I met other EDS patients who had it too. I didn’t realize children and women who have never been pregnant can prolapse. But we do!” – Jill D.
“Along with pelvic organ prolapse we are also subject to rectal prolapse [and] rectocele prolapse. Many of us have GI motility issues which predispose us to chronic constipation, pair that with our overly stretchy connective tissues and surprise, surprise, very early on we can develop issues.” – Alexandria M.6. Gastrointestinal Issues
“Bowel issues. Might need to have a surgery due to my butt being too stretchy. A bit freaked out but how do you talk to people about booty surgery.” – Amber B.
“Food digestion issues – especially vomiting.” – Diane F.
“Rooty. Tooty. Stinky. Booty. My tummy doesn’t behave properly and gives me all sorts of trouble… including copious amounts of noxious gas.” – Daisy R.
Want to connect with other EDS warriors? Download our free app to more easily ask questions, share your experiences, and receive support.7. Fatigue
“Fatigue but can’t sleep… I’m talking exhaustion, barely enough energy to breathe let alone shower, dress eat, etc.” – Sonia J.
“Things that are two steps for [most] people become 12 steps when you have EDS. People not understanding the feat it is to make myself a sandwich has been so difficult. I see grabbing every ingredient or movement as its own mountain and a sublux risk. Every move becomes calculated and risky. The amount of complexity in simple actions is something I wish others would get and I could talk about. It’s taboo to vent about how hard these simple things are.” – Emily L.8. Pelvic Instability
“In addition to prolapse issues listed by others, we can have pelvic instability. Many deal with rotations of the SI joints, and even the pubic symphysis. People often blush when I bring that up, but there are ortho PT options to address it.” – Justine C.9. Difficulty Swallowing
“Difficulty swallowing… then losing ability to speak (hoarse voice/no voice) after a choking/coughing fit.” – Kristen K.
“Esophageal dysmotility. One minute you’re eating, maybe at a restaurant with friends or family, and the next minute, your throat stops working. And now, you’re sitting there with food or even water halfway down your throat, just stuck there, won’t go down, won’t come up. And you’re just sitting there, horrified, humiliated, while your face turns red, and slobber starts running out of your mouth, as you furiously attempt to swallow down the lump in your throat. I rarely go out to eat anymore.” – Tammy B.10. Having “Bad” Posture
“I have trouble holding my own body up, and that must be impossible for other people to understand. My posture is awful. My head is so heavy, my neck and back only have so much strength, and I can’t hold my arms over my head long enough for self-care anymore. When I’m out and about, it’s hard to stand up, so I’m always leaning on something – a wall, a chair or whatever is nearby. At work, I’m always slumped over my desk, or leaning back in my office chair, no in between. I feel like people must think I’m lazy, and sometimes I’ve even heard people who know me well call me lazy, but my muscles can only work so hard to hold up this wobbly body!” – Carolyn R.11. Fear
“The constant fear of not being able to trust that your body is going to keep you upright throughout the day.” – Michelle R.
“The fear and doubt of never being able to live a fulfilled life or achieve your goals. The feeling of being a burden because you can’t go out due to your ankle and back being dislocated. People don’t understand what it does to you or how difficult it can be to be functional.” – Ashleigh F.
“There is a fear as a parent that a third party will see my chronic condition as a disqualification to raise my children despite them being clean, happy and fed at all times.” – Denyl B.12. Painful Sex
“Sex hurts! You can dislocate during… totally sexy. Too tired… understatement. The list goes on. But you get the idea.” – Charity M.
“Dislocating joints during sex. Having to tell partners that you can’t do certain things during sex because something can/will dislocate can be kind of embarrassing but these kinds of talks are required for us with EDS.” – Haley T.
“Becoming masochistic because it’s either sexy pain or go without. Also taking off the orthopedic belt in the heat of the moment is sooo hot!” – Lorrie B.
Ehlers-Danlos syndrome does not “just” cause hypermobile joints and stretchy skin. It is important that others understand the many ways EDS can affect people so they can fully support the EDS warriors in their everyday life!
https://www.yahoo.com/news/12-taboo-symptoms-ehlers-danlos-202803845.html
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