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Ethicon Media Monitoring 3/5/2019
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FDA Tightening Regulatory Requirements For Some Medical Devices
Mar 4, 2019 | NPR
By Blake Farmer
There's no doubt that surgically implanted medical devices can improve lives. -
Week ahead at Holyrood: Brexit countdown
Mar 4, 2019 | BBC News
By Louise Wilson
With 25 days until Brexit, the task of narrowing down what will happen next is at the forefront of politicians' minds. -
One Week from Hernia Surgery to Swimming in Hawaii!
Mar 4, 2019 | Mesh Medical Device News Desk
By Jane Akre
...It happened about one year ago when I suddenly noticed a sharp pain in the lower part of the stomach around my leg. The pain was stronger when I walked and would calm down when I rested. I hoped it will go away.
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FDA Tightening Regulatory Requirements For Some Medical Devices
Mar 4, 2019 | NPR
By Blake Farmer
There's no doubt that surgically implanted medical devices can improve lives.
Hip and knee replacements can help people regain their mobility. Drug pumps can deliver doses of pain-relieving medicine on demand. And metal rods can stabilize spines and broken bones.
But implanted devices can also do serious damage, as happened to Mechel Keel, who lives in Owosso, Mich.
To fix her leaky bladder, an OB-GYN stitched a flexible mesh strap inside her pelvis in 2004. But within months the mesh hardened and started cutting her insides.
The pain kept her from returning to her job as a hairdresser. The injuries and scar tissue that developed required multiple surgeries to correct and also resulted in chronic infections.
Keel says she understands 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."
Thousands of cases of complications from surgical mesh have been reported to the Food and Drug Administration. More and more ailments are being treated these days with medical devices, including 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 some devices break down or malfunction in people's bodies, and reports aboutsometimes debilitating injuries have led the FDA to rethink how it assesses medical devices before allowing them to be sold.
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 premarket approval. But most medical devices enter the market after manufacturers provide technical information and show that the devices are similar to others that have been legally sold previously.
The FDA has acknowledged that some seemingly safe devices have caused major problems, and the agency has elevated the risk level of those products following reports of injuries, as it did with urogynecologic surgical mesh for some uses in 2016. "Unfortunately, the FDA cannot always know the full extent of the benefits and risks of a device before it reaches the market," the agency said in a recent statement.
"We have things like metal-on-metal hips," says health journalist Jeanne Lenzer about a kind of orthopedic implant. "Outside the body, [they] 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."
There have been massive recalls of hip implants, for example, due to devices causing swelling and pain. And there have been problems with weakened bones in patients who received hip implants that contained plastic.
Lenzer 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 the way drugs do.
That's in part because of a regulatory review process known as 510(k) for a section of the FDA law covering medical devices. Manufacturers typically show their product has "substantial equivalence" to a "predicate device" that has already been legally marketed.
That standard can perpetuate problems. "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 relevant example, with much of what's on the market being based on mesh that was around prior to implementation of FDA regulations for medical devices in 1976. One study found that 16 percent of mesh on the market was designed like products that had been pulled from the market because of safety concerns.
Thousands of women, including Keel, have filed suit — or reached settlements — with medical device companies that manufacture pelvic mesh.
"I would want nothing if you could just give me my life back," says Gloria Jones of Hillsdale, Mich., who is one of thousands who've settled with device manufacturersover faulty mesh. "They could have given me millions, but all I needed was my life back."
Jones, who has struggled to continue working through crippling abdominal pain as a middle school special education teaching assistant, has had four surgeries to remove pieces and continues to require intravenous drugs to control infections.
"It seems like I get off one antibiotic, and three days later, I have another one," she says. "I would beg anybody who is even thinking of putting mesh in their bodies to stop and get a second opinion."
In response to problems reported with mesh, the FDA started requiring human testing for some of these products in recent years. The agency held an advisory committee meeting on Feb. 12 to discuss the safety and effectiveness of mesh and how it should be regulated.
Manufacturers by and large have said they don't oppose what the FDA is trying to do, calling the changes reasonable. But they have pushed back against calls to bring regulation of medical devices in line with that of pharmaceuticals.
"If you're treating someone for high cholesterol, the testing that you go through to ensure safety and effectiveness on a chemical that's going to be used in your body to control your cholesterol is just very different than it would be for the implantation of a heart valve," says Scott Whitaker, CEO of AdvaMed, a trade association for medical device companies. "Honestly, it's apples and oranges."
Whitaker dismisses the idea that devices, which range from tongue depressors 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. But it doesn't all fit the same and can't all fit the same standard," Whitaker says. "And while we always strive for 100 percent, there are times when something might not go according to plan. It could also be because the surgery didn't go as was planned."
The FDA declined NPR's request for an interview. But the agency 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 more than doubled in size to an average of 1,185 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 addressed 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's marketing application on one that's more than 10 years oldMore actively watching how devices perform once they're on the market, rather than relying on patients to report problemsScrapping the 510(k) name for something more descriptive, the "Safety and Performance Based Pathway"
Dr. Michael Matheny, a Vanderbilt University professor who tracks medical devices, approves of the FDA's incremental approach and calls it thoughtful.
"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 can be more profound for devices than medication. If the FDA recalls pills, a patient can at least stop taking them immediately, he says. With implanted devices, patients are sort of stuck, at least for a while — and that's if surgeons can even safely remove them.
https://www.npr.org/sections/health-shots/2019/03/04/689739642/fda-tightening-regulatory-requirements-for-some-medical-devices
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Week ahead at Holyrood: Brexit countdown
Mar 4, 2019 | BBC News
By Louise Wilson
With 25 days until Brexit, the task of narrowing down what will happen next is at the forefront of politicians' minds.
MSPs are set to debate withdrawal negotiations for almost four hours on Tuesday afternoon - an unusually lengthy timeslot for the Scottish Parliament.
It comes ahead of a series of votes taking place at Westminster next week.
If a majority in the House of Commons do not back an alternative, the UK will leave the EU on 29 March without a deal in place.Brexit: A really simple guideMay offers MPs Brexit delay voteLabour will support Brexit referendum
This is an outcome the majority of MSPs hope to avoid.
Four of the five parties at Holyrood have now backed an extension of Article 50 and for another referendum to take place.
What could be interesting is whether a new line will come from the Scottish Conservative benches.
So far Tory MSPs have been foursquare behind the prime minister's deal, warning that this is the only way to prevent a no deal Brexit.
What else is happening at Holyrood this week?
Tuesday - mesh implants
Tune in on Holyrood Live
Bookending the Brexit debate will be topical questions and a member's debate led by Labour MSP Neil Findlay.
He is highlighting reports that the Scottish government has declined support from a mesh removal expert.
Vaginal mesh implants are used by surgeons to treat conditions which some women suffer from, typically after childbirth.
But their use was stopped in 2018 after an implant was listed as an underlying cause of death of a woman in August.
Dr Dionysios Veronikis has developed skills and instruments that allow for the full removal of a mesh implant, a procedure not currently available across all health boards.
The Scottish government has said the decision to remove mesh is made by the patient and her doctor, with specialist centres located in NHS Greater Glasgow and NHS Lothian.
In the morning, Brexit preparation is hotting up with all five committee scheduled to meet considering secondary legislation around it.
The economy committee will hear from Economy Secretary Derek Mackay on regulations to bring EU public procurement rules into domestic law.
Before this, the committee will be taking evidence from construction experts and apprentices about the impact of the sector on the Scottish economy.Wednesday - ASN in schoolsWatch on Holyrood Live
The Scottish Tories have the floor on Wednesday afternoon with two debates.
The first will cover the early years, while the second will be on rural affairs. Information on the specifics will be published later.
Before this, finance and environment ministers will face portfolio questions.
The evening's member's debate is being led by SNP MSP Gordon Macdonald, highlighting Marie Curie's 33rd annual great daffodil appeal.
In the morning, the education committee continues its inquiry into additional support needs in school education.
Its members warned in 2017 that there was a lack of support for children with additional needs in many council areas across Scotland.
This inquiry is assessing whether progress has been made in the last two years, taking evidence from two charities - Enable and the National Autistic Society Scotland - as well as the Scottish Secondary Teacher's Association.
Thursday - council funding
An hour on Thursday will be spent discussing the Local Government Finance Order, which allocates funding to each of the 32 councils in Scotland for 2019-20.
The opposition benches will insist this is not enough while the Scottish government will highlight the amount received by every council will go up.
But since the Budget Bill was passed last week, this debate is simply the final part of that process and will not in effect change anything.
The weekly performance of first minister's questions takes place at noon - and MSP Alison Johnstone gets her first question as co-leader of the party.
Afterwards, SNP MSP Annabelle Ewing leads a debate on settled status fees, which the UK government decided to scrap in January.
Rural ministers face portfolio questions at 2pm, in a change of scheduling from its usual Wednesday position.
International Women's Day will be marked by MSPs after the council funding debate.
In the morning, school children from Parkhead Primary School will give evidence to MSPs about first aid training.
They will be joined by representatives from St Andrew's First Aid who are calling for the training to be given to all primary school children.
https://www.bbc.com/news/uk-scotland-scotland-politics-47440457
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One Week from Hernia Surgery to Swimming in Hawaii!
Mar 4, 2019 | Mesh Medical Device News Desk
By Jane Akre
Vladae Roytapel is known as the, Russian Dog Wizard, from Newport Beach, California. Voted Best Dog Training Company in 2015, 2015 and 2017 by City Voter, his business is SoCal Dog Training Inc. He is originally from Baku, Azerbaijan, the former Soviet Union.
He emailed Mesh News Desk after seeing the story that Sen. Ron Paul (R-KY) was travelling out of the country to Canada to have his hernia repaired.
Roytapel went on his own journey to find a doctor to repair his hernia. This is his story in his words (some translation needed).
OLD SCHOOL HERNIA REPAIR – A Miraculous Recovery!
One week from hernia surgery table in California to Swimming in Hawaii
“First, a little background!
“It happened about one year ago when I suddenly noticed a sharp pain in the lower part of the stomach around my leg. The pain was stronger when I walked and would calm down when I rested. I hoped it will go away.
“Well, I went to the doctor and he told me that the ultrasound showed some inflammation. The doctor gave me an anti-inflammatory/ antibiotic treatment and the pain disappeared for a while. But one day I noted a big bulge on my right side. I went to the doctor again that day and was diagnosed with a hernia.
“Being a quite renowned expert in the dog training industry and having a very influential and loyal clientele, they introduced me to one top doctor in a well-known hospital here in Newport Beach.
“It was a 20 minute visit. The doctor offered me mesh. He even told me that he will put a bigger patch in to cover the left side as well, just in case. Can you only imagine? He told me that pain may happen and I also possibly may have the FEELING of mesh in my body. While he said this he was smiling and laughing. I received a $300 bill later. OMG.
“I started my research and learned how many human lives were ruined with surgery that was supposed to be minor. Mesh surgeons will tell you that the risk of a side effect is very low and recovery is fast. Well, according to statistics, long-term complications are hitting now 30% – short term gain (if you are lucky) and long term pain!
“My famous clients – Beverly Hills plastic surgeons – told me that in plastic surgery the unwritten rule is ‘Don’t put anything in if it can’t be safely removed.’ If, God forbid, you will be the one who mesh needs to be removed from, you will be sorry for the day you was born.
“I joined an online hernia talk forum and become senior member and No Mesh advocate!
“In the beginning I was like many of people searching for the best method but soon I realized that it wasn’t a good plan. What if that method isn’t the best method? “One tool never fits all” so from that time I started my search for doctor, I wanted to travel less, I wanted a doctor who was a hernia-only doctor and would, of course, take my insurance.
“I had multiple phone calls, spoke with a few doctors and sent very tough questions to different doctors and their former patients. My final choice was Dr. William H. Brown a Sports Hernia Specialist.”
Only of Few in the Country- No Mesh Doctor!
“This is what I was looking for:
1. An expert in applying multiple methods with principles – LESS is MORE – fix just what is broken.
2. An amazing person /caring beyond your expectations.
3. He loves his work, not money!
4. To understand how crazy, sensitive a person I am. I can’t take any pain, so he needs to go beyond and above meticulous to handle my tissues as he would do, a not hernia, but oculoplastic (eye) surgery.
5. I know myself. That every pain I have will cause panic. Only Dr. Brown could take a client like me. I even could call him on his cell phone or text him.
6. He is a Sports hernia expert. Sport hernia is more difficult to fix then common inguinal hernia.
7. He does no-mesh only!!!!!!!!!!!!!!!!!!!
8. Recovery and strength of repair was, for me, vital. I am self-employed so no working means no making money. Dr. Brown fixes hernias for athletes who need to perform again. Sounds like me.
“Hernia surgery should not make you handicapped for life. I have a lot of health problems already and to add one more – Thank you but No Way! My wife took a two-week vacation and we booked a one way ticket to meet Dr Brown.”
Meeting Dr. Brown
“After a one-hour short flight we landed in San Jose, California and rented a car and booked a hotel literally walking distance from the surgery center and a 5 minute driving distance from Dr. Brown’s office. We visited Whole Foods market to get a lot of food/supplements and were ready to meet the doctor the same day.
“We found his office very easily and were surrounded with love and hospitality with his staff and surgery coordinator, Belinda. The doctor came very quickly. He was very energetic, confident and friendly. Here is photo of our first meeting. The map behind represents every country that he had people coming to him for help. He took a very detailed look at both sides and noted that once he opened me up he will see more.
“I had a very simple indirect hernia that for him to fix is as easy as for me to put a Labrador retriever into a sit-stay command.
“We had fun too. I said to him with humor ‘Look doc, unless your other cases you will operate fresh here! No revision surgery. No inflamed tissues No mesh removal so please, no excuses!! Please do it right. God forbid to touch any nerves or cut anything.’
“He laughed and said, ‘YES SIR!’ LOL. I knew I was in the best possible hands. If he can take me, he can take everyone. We were ready for surgery the next day.”
Surgery Day!
“We truly loved the surgical center. It was unlike a big hospital. We felt those people really care! It was very simple – come into the room, undress, and they will move you to the surgery room. It was funny. I still was afraid of any mistakes (knowing our medical system) so I even marked with an arrow the side of my body where to operate. But they did mark it with even bigger letters DO and DON’T on the opposite side. I was thinking that I would not see doctor before surgery, so I texted him a kind reminder – don’t take too much out of position of the spermatic cord to prevent any later pain.
“To my big surprise, the doctor came himself into my room and personally put into my blanket a kind of warm air hose to comfort me and we together came to the surgery room. We also decided on using just partial local sedation and not complete sleep. That I believe was much easier on me once he did it.
“I didn’t feel anything. The doctor told me that I had both a (hidden) direct and obvious indirect hernia so that was a bit surprising. He changed his original plan a bit. I am sure Dr. Brown can give more details here. He gave me photos and a CD. We recorded the step-by-step surgery.
“To make a long story short, after surgery I didn’t feel any pain and was ready to drive home but my wife said NO!! :}}} And we drove to the hotel to start the recovery process.”
“Dr. Brown later explained the process:
“The indirect hernia was treated by dissecting the hernia sac back into the retro peritoneal space and then inverting the sac and securing the reduction with a pursestring. The inguinal floor was weak secondary to the chronic indirect hernia. I reconstructed the floor with a limited Bassini. This also had the effect of a ringplasty. The external oblique was imbricated over the floor to provide additional reinforcement.”
Recovery First Week!
“In the morning I took off the bandage and later showered. There was not too much swelling or discoloration. Well, I had some of it down the road but just a bit and it went away.
“My first mistake I made that night before I went to bed, I didn’t take any medication and allowed the surgery numb injection to totally stop its effect. I felt so good before going to bed so I ignored doctor’s orders.
“It was Russian Roulette! So I woke up with pain!!
“My first motion was to get my iPhone and call Dr. Brown for rescue. You believe it or not he already was trying to call me and even texted me to ask about my feeling…. Nice! Dr. Brown very promptly put me back to comfort but truly speaking first 2/3 days will not be your best DAYS in life!
“I was determined get back on my feet to continue perform my dog training service as soon as possible. Being self-employed is tough – no work no income, no paid vacations or sick days ever.
“Every day not working is a loss. I needed to be like a dog and lick my cut and move forward with my life. So from the first hour after surgery I moved forward with my main reserve – my Russian wife!
“She aggressively attacked the pain and inflammation with natural remedies and a Bone Broth/Collagen/Gelatin-boosted diet.”
Result!
Dog training in Hawaii
“Well at the end of first week I already was 60 percent normal. Yep, it was pain when I move clumsily, but no big deal. It was just a short-term pain and I hoped for a long-term gain.
“I visited Dr. Brown two times the first week and got his attention to every spot on my skin. I think by that time he released me he knew what he got himself in, but everything paid off. I felt stronger every day. So at the end of the week I started to look for trouble!
“I felt very sorry for my wife who worked so hard to help me and we never went on vacation since we immigrated to the USA for 25 years!!! So I asked Dr. Brown, ‘Can we fly to Hawaii?’ He said Go for it! And we booked the tickets.”
Trip in Hawaii – My Second Week after Surgery!
“It didn’t start well.
“Here is my second mistake that happened! I underestimated my strength and fast walked with rolling luggage from one terminal to another. We were late and missed the plane anyway, but that evening I started to feel like electric pulses inside the cut. Thank God, next day it was over.
“I even called Dr. Brown and I asked if I could have ripped the stitches. He said no way. I put in durability for athletes. He even told me about one person who fell at home from the stairs but his repair held on.
“Basically he nicely told me, ‘No worries, just shut up. Take your poor wife to the Hawaiian Beach.’ I took the doctor’s orders! Five hours later I was swimming and even trained dogs in Hawaii. My work is never done!
“Thank you Dr. Brown!”
https://www.meshmedicaldevicenewsdesk.com/one-week-from-hernia-surgery-to-swimming-in-hawaii/
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