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Ethicon 26/03
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Experts Divided On FDA's Approach To Medical Device Regulation
Mar 25, 2015 | Med Device Online
By Jof Enriquez
...She points out an increasing array of high-risk devices — morcellators, metal-on-metal hip implants, pelvic mesh implants, inferior vena cava filters — that were approved but were later shown to be dangerous and even lethal to many patients... -
Welcome MAM – Mesh Awareness Movement Gathers Women in Support
Mar 26, 2015 | Mesh Medical Device Newsdesk
By Jane Akre
We need to rally together, all the victims, family members and supporters to organize peaceful and supportive gatherings showing our many faces, reminding them (Judges, Defense Attorneys, Mesh Manufacturers and our Attorneys) that we are not just case numbers! -
Does Body Fat, Other Factors Cause Incontinence?
Mar 25, 2015 | OBGYN.net
...The study noted that urinary issues, including frequent urination, nocturnal urinary urgency, stress incontinence, and urge incontinence, are very common among women at the time of menopause and in the years following...
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Experts Divided On FDA's Approach To Medical Device Regulation
Mar 25, 2015 | Med Device Online
By Jof Enriquez
The U.S. Food and Drug Administration (FDA) attempts to walk the fine line between protecting public health safety and encouraging the development of innovative medical devices. There is no shortage of differing opinions on whether or not the FDA’s current regulatory approach towards medical devices should be overhauled, slightly tweaked, or stay the course.
When the Wall Street Journal recently talked to three experts about the topic in a roundtable discussion, their views reflect how divided stakeholders are on device regulation.
Scott Gottlieb, former FDA deputy commissioner, believes that the agency has deviated from its original mandate by overreaching in areas it was not designed to monitor.
In the interview, he says that the FDA has unfortunately shifted towards applying a “much more uniform and druglike approach to its regulation of medical devices,” instead of focusing on risks associated with a particular device. Gottlieb says that this approach has led to the creation of unnecessary hurdles for newly developed devices.
He also describes as “unethical” and “unnecessary” dummy surgical procedures that he says the FDA has asked manufacturers to conduct as part of the review process. According to him, such procedures place the patient at risk without clear benefits.
However, another expert interviewed by the WSJ says that those placebo-controlled device trials were not required by the FDA. Bradley Merrill Thompson, a device attorney with the firm Epstein, Becker & Green, says companies are actually the ones who suggest these trials, and the agency merely permits them.
Thompson also countered Gottlieb’s expressed view that the FDA is unnecessarily clamping down on low-risk consumer apps by treating them as medical devices.
“In the last couple of years, [FDA] has sought to reduce, not enlarge, its regulatory oversight,” Thompson told theWSJ. “For example, it has deregulated the hardware and software that takes data from medical devices like a blood glucose meter and transmits it for storage and display. That was a big step forward.” (For more on this topic, seeFDA Cuts Its Oversight Of Medical Device Data Systems.)
Rather than sweeping regulatory reform, Thompson is in favor of “continuous improvement guided by continuous review of agency performance data as well as marketplace and scientific trends.”
Meanwhile, a third expert in the discussion, Rita Redberg, a cardiology professor at the University of California, San Francisco (UCSF), says that only a few percent of all medical devices are required to undergo a pathway that lacks stringent evidence-based clinical trials.
“As a cardiologist taking care of patients every week, I see too many whose lives have been harmed and who have suffered greatly from untested or inappropriate devices,” she told the WSJ. She points out an increasing array of high-risk devices — morcellators, metal-on-metal hip implants, pelvic mesh implants, inferior vena cava filters — that were approved but were later shown to be dangerous and even lethal to many patients.
“Simply put, for the vast majority of medical devices, there is NO requirement to demonstrate safety and effectiveness,” says Redberg.
She suggests establishing national, publicly available registries of devices and procedures for tracking real-time outcomes and preventing catastrophic device failures.
All three experts lament the fact that device failures have caused deaths and injuries to many patients. However, Gottlieb and Thompson say that simply requiring manufacturers to perform larger and more clinical trials to prevent these occurrences will not ensure device safety, according to the WSJ.
“My concern is that a lot of the fundamental questions about device safety turn on issues of biomechanical performance,” says Gottlieb. “For example, some common questions are how resilient an implanted valve will be to the shearing effects of blood flow, a joint to constant stresses, or the durability of a pacemaker’s circuits.”
According to an FDA report cited by the WSJ, the number of defective devices that were recalled nearly doubled in the decade ending in 2012. However, Gottlieb and Thompson say that everyone must consider the overall picture.
“Out of all of the thousands of medical devices that the FDA clears each year, how many turn out to be unsafe or ineffective? Not many,” says Thompson. “But further, and equally importantly, how effective are alternative regulatory systems in approving important new medical devices in a timely way? Changing the system in a way that delays or even forecloses the sale of safe and effective breakthrough medical devices hurts patients, too.”
Gottlieb expressed the same view, saying, “Keep in mind that 99.8% of all medical devices have no serious adverse events associated with them. The U.S. is the gold standard when it comes to device safety.” He pointed out the implementation of the unique device identifier (UDI) as one initiative aimed at improving safety.
The U.S. Congress is working on separate measures to overhaul how the FDA regulates medical products. The nation’s largest medical device trade group, AdvaMed, also released a report that complements the language and scope of regulation over medical devices used in those legislative proposals, according to the Regulatory Affairs Professionals Society (RAPS).
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Welcome MAM – Mesh Awareness Movement Gathers Women in Support
Mar 26, 2015 | Mesh Medical Device Newsdesk
By Jane Akre
This section is dedicated to all the mesh victims, their families and supporters specifically for organizing, discussing, planning or anything else related to the Mesh Awareness Movement.
This includes dates, times and locations for peaceful MAM gatherings, creating MAM media awareness ideas and sharing links, volunteering, networking, etc etc.
We need to rally together, all the victims, family members and supporters to organize peaceful and supportive gatherings showing our many faces, reminding them (Judges, Defense Attorneys, Mesh Manufacturers and our Attorneys) that we are not just case numbers!
I understand we are not to speak of the details of our case, but we CAN be seen! We don’t need to yell or hold up offending signs. Our presence alone is enough to send the powerful message we need. STANDING TOGETHER, UNITED IN SUPPORT.
I am not asking anyone or suggesting in any way that we jeopardize the outcome of our cases. Anyone uncomfortable about this can simply BE PRESENT at one of the gatherings and not say a word. If we stand together, I truly believe we can make a positive difference.
There are several ways we can do this.
I know most of you are like me, in pain and struggling financially or drowning in debt which makes it difficult to commit to expensive travel or you’re in too much pain to make the journey to West Virginia. Perhaps there’s a solution, all those able could gather at your own state capitol building on July 12th and/or 13th. I’m sure there are enough victims, family members and supporters to cover every state in this country! And if we can get news coverage… even better!
For those who physically can’t make it to their state capitol, we are working on ideas to get you there in spirit. You will not be left out. But first and most importantly, MAM needs volunteers. If you want to help but you’re in too much pain to move, we’ll find a way for you to be a part of this movement from your bed or chair. No one will be left out. You can remain anonymous or use a fictional name, whatever makes you comfortable. I’m volunteering myself to help organize all of this because I’m tired of being stagnate! But I sure could use some help, I have the willingness but not all the “know how” for social communication and media coordinating so I’m asking for volunteers to be on the steering committee. We’ll also need a volunteer from each state to be the lead contact for that state. This will get us started.
Currently we are working on MAM gatherings for Sunday, July 12th 2015 at the State Capitols and Monday, July 13th 2015 at the State Capitols and at the Courthouse for the opening day of the Bellwether Trial in West Virginia.
We are also working on; MAM ribbons that we can all proudly wear, maybe made from black mesh fabric with a purple felt heart in the middle? (Volunteers and ideas still required) MAM quilt made from squares of fabric donated by and representing each and every victim. This quilt will be taken to the courthouse in West Virginia on July 13th and held with honor. (Volunteers needed to collect/receive all the fabric squares donated by the victims, and volunteers needed with sewing machines to sew them together) MAM is for all of us!
Your ideas, suggestions and opinions are the heartbeat of this movement. I consider myself blessed to be a part of it and I’m looking forward to sharing in the love and support of all the others involved in the Mesh Awareness Movement. Yes MAM Lets do something! Lisa (Florida). Write: meshawarenessmovement@gmail.com
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Does Body Fat, Other Factors Cause Incontinence?
Mar 25, 2015 | OBGYN.net
Body fat, slowed reaction time, and poor sleep are associated with women who experience urinary problems during and after menopause, a recently published study found.
The study noted that urinary issues, including frequent urination, nocturnal urinary urgency, stress incontinence, and urge incontinence, are very common among women at the time of menopause and in the years following.
Key Points:
- Researchers linked urinary troubles in menopausal women to excess body fat, poor sleep, and slowed reaction time.
- However, no direct cause and effect in the relationship of these common symptoms among women during and after menopause was documented.
While no causal relationships between weight, sleep, or reaction time were identified, the researchers said that their relationship to storage lower urinary tract symptoms is worth a closer look. “Careful evaluation of nonrestorative sleep, body fat and visceral fat accumulation, or delayed reaction time might reveal undisclosed storage LUTS in this population,” the authors concluded.
The research involved approximately 350 Japanese perimenopausal and postmenopausal women ages 40 to 76 years old enrolled in a health and nutrition education program at the menopause clinic of the Tokyo Medical and Dental University Hospital. The data was obtained through completed questionnaires from each of the women.
Nearly half of the women said they experienced urinary frequency more than once a week, including 22% saying it was a nearly daily occurrence. Stress incontinence was reported by 33% of the women, while nocturia and urge incontinence each bothered about 11% of the women.
Furthermore, stress incontinence was statistically linked to increased body fat (odds ratio, 1.06; 95% CI, 1.03-1.09), while urge incontinence was associated with reaction time (odds ratio, 1.10; 95% CI, 1.01-1.19).
The study didn’t determine a cause and effect, so it’s unclear whether the urge to urinate in the middle of the night is caused by poor sleep or if the need to use the toilet is causing the poor sleep. Similarly, the authors said they were unable to determine whether excess weight was leading to urinary problems.
The study was published online by Menopause, the journal of The North American Menopause Society (NAMS), and will appear in the print version later this year.
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