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Ethicon 22/6
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Pudendal Neuralgia and Pelvic Mesh: Serious Injury – Serious Decisions
Jun 21, 2016 | Mesh Medical Device Newsdesk
...As a physician he specializes in Physical Medicine and Rehabilitation caring for patients with severe traumatic brain injuries and spinal cord injuries. He understands` the game changing effects of these injuries on the patient and her family. -
Reporters Resource on Covering Pelvic Mesh Issues
Jun 21, 2016 | Mesh Medical Device Newsdesk
...For reporters looking for a way to get started on the transvaginal mesh story, here are some highlights to shortcut your research. -
Mesh mini slings cause “serious complications” and research into their use is “disappointing” says report by NICE
Jun 21, 2016 | Wisbech Standard
By Kath Sansom
...A mesh sling surgically implanted to cure women suffering embarrassing leaks, usually caused by pregnancy, has been criticised for causing serious complications, pain and discomfort. -
Bladder neck evaluation by perineal ultrasound before and after reconstructive surgery for pelvic organ prolapse.
Jun 21, 2016 | UroToday
By Manabu Nishibayashi, Koichi Kobayashi, Akinori Miki, Ryugo Okagaki, Ichiro Nagata, Mitsuyoshi Urashima, Osamu Ishihara
To study the correlation between stress urinary incontinence (SUI) and the mobility and funneling of the bladder neck (BN) by observation of pre- and postoperative course by perineal ultrasound (PUS).
Client Attorney Privileged/Attorney Work Product/At Request of Counsel
Online Sources
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Pudendal Neuralgia and Pelvic Mesh: Serious Injury – Serious Decisions
Jun 21, 2016 | Mesh Medical Device Newsdesk
Greg Vigna, MD, JD, is both a doctor and a lawyer who is directing his expertise as a traumatic injury specialist now to pelvic mesh injuries. This story is reposted from last October. At the time, Dr. Vigna was a sponsor of Mesh News Desk, which he is not today.
As a physician he specializes in Physical Medicine and Rehabilitation caring for patients with severe traumatic brain injuries and spinal cord injuries. He understands` the game changing effects of these injuries on the patient and her family.
He is also a Certified Life Care Planner who understands the economic cost of a catastrophic injury both now and in the future. Third, he is a personal injury attorney who only represents those with catastrophic injuries. Dr. Vigna focuses on the severe pain syndrome of pudendal neuralgia or nerve pain from injury to the pudendal nerve. One of the most read stories on Mesh News Desk is about pudendal nerve damage from mesh used for pelvic organ prolapse (POP) and stress urinary incontinence (SUI).
Q: What brought pelvic mesh pelvic mesh injury cases to your attention?
A: Pudendal neuralgia (PN) is a catastrophic injury as damaging to the life of an individual as paralysis from the waist down. As a physician I recognize there is a great cost to a catastrophically-injured person and their family, psychologically and economically. The purpose of going into TVM caused pudendal neuralgia is this is one of the most difficult, expensive disorders one has to live with. The lifetime cost in relation to treating pudendal neuralgia is easily $1.4 million to $2 million over a lifetime.
I see spinal cord and brain injuries all the time. A person is hit on the freeway by an uninsured motorists and suddenly they are no longer economically viable. Their families are now indigent. Here we have a similar situation. The purpose of product liability law is to cost-shift to those better able to handle the cost. In this litigation for the worst injured there has not been a successful cost-shift. These women are disproportionately left to become indigent. I’m pleased to say there are attorneys willing to step up to represent all, including the 2 percent who are severely injured.
Q: It’s fair to say you are not trying to represent or help all injuries resulting from pelvic mesh implants?
A: I believe one to two percent of women involved in this litigation have a pain syndrome consistent with pudendal neuralgia. Simply, there are only a few medical conditions as destructive to an individual and the family unit as a pudendal neuralgia. It is a horrendous pain syndrome that interferes with any meaningful mobility and interferes with sexual, bladder, and bowel function. As a physician who sees over ten spinal cord injured patients a day, without hesitation I would rather be paralyzed from the waist down than have what these women have.
Q: To what extent does the POP and SUI mesh surgery and the trocars play in causing pudendal nerve injury?
A: To date there has not been a trial that highlights pudendal nerve injury other than Linda Gross trial. In pelvic organ prolapse surgery (POP) there is a blind component, which offends common sense. I’m more concerned with the word ‘blind’ than the use of trocars since ‘blind’ should not be in the same sentence as the word surgery. There are certainly anatomical variations in humans and even a properly placed device will come dangerously close to the pudendal nerve. There are pudendal neuralgias (pain) in appropriately positioned devices that may directly injure the nerve or over time will be pulled by traction as well as scar tissue from the foreign body response that causes entrapment and nerve damage.
Dr. Mario Castellanos, a urogynecologist specializing in mesh related pudendal neuralgia, published a study in 2012 that described the anatomic basis of pudendal neuralgia with the JNJ Prolift. This study shown that the arms of the device came within a centimeter of the rectal branch of the pudendal nerve. There are no treatments for that damage. They have intractable rectal pain and dyspareunia and there is no decompression surgery that deals with the rectal branch. In SUI, the literature is clear, there is a six times greater chance of damage with any sling device that offends the obturator membrane.
There is a busy pain pelvic pain clinic in Phoenix that has only seen one case of a severe pain syndrome from a retropubic sling (TVT). All of the rest are from the TVT-O. Over time, I believe transobturator slings will cause more damage than POP devices. The FDA still has not moved on transobturator slings. Over time the litigation process will end transobturator slings. If not, I will sue them into perpetuity.
Q: Are they defectively designed?
A: Yes. When the obturator membrane is involved the obturator nerve and the pudendal nerve are at risk of injury, both acutely and over-time. They’re trying to make it smaller with less mesh, to hook onto the membrane but still these devices such as the mini-arc single incision device are all defective.
If you are going to ask one question, of your doctor who suggests mesh, I’d ask why not use the retropubic sling (TVT) versus the ones that offend the obturator membrane? If they say with the retropubic sling there is a potential of puncturing the bladder, those issues are easily dealt with because the bladder heals but nerve damage is nerve damage. The catastrophic pain syndrome that turn women into train wrecks are from the transobturator slings.
Q: What are a woman’s chances of recovering from pudendal nerve damage?
A: If a pudendal nerve is entrapped, six months after decompression I can predict what kind of life care needs a patient will have. I’ve had clients who have improved; they can function and sit. My goal is to educate women to empower them to get the care they need to demand from their doctors the care they need and deserve. With education, they are empowered to ask their attorney if this is a situation that would require individual litigation. And if those attorneys want to proceed with individual litigation or meaningful settlement discussions, I can help with case management, ensuring the life care plan is adequate by reviewing the life care plan and critiquing it. I am offering that as a non-consulting expert through my company Litigation Support Consulting Service, LLC.
Q: What led you to Dr. Hibner who you did the e-book with?
A: Simply he was the only physician at the time providing what I believed was a rational treatment for pudendal neuralgia. The general tenant is that one must attempt complete mesh removal of the device both vaginally and abdominally with the Da Vinci Robot. If pain persist that is consistent with pudendal neuralgia there must be a diagnostic block and then pudendal neurolysis (or decompression) if the nerve is found to be entrapped in surgery.
Q: In general, how do you see this litigation going?
A: First, as a physician I must say the medical community has failed in mobilizing to protect and treat these women. There has been an utter lack of leadership from the American College of Obstetricians and Gynecologist. Simply by making a mandatory Continued Medical Education requirement for clinicians to participate in that describes the symptoms of pudendal neuralgia could have saved significant distress for women turned away by uneducated ears. To date I am unaware that American Medical Systems, JNJ, Boston Scientific, and Caldera informed their implanting surgeons of the symptoms of pudendal neuralgia which is clearly the most severe medical complication from both a properly placed mesh device or a malpositioned device which is an expected outcome of the flawed design.
Second, it is an impossibility to provide equitable compensation to everyone involved in an aggregate settlement of this magnitude. That being said, for the most part the settlements to date have done fairly well for 97 to 98 percent of the injured women understanding the cost and delays of individual litigation. I must clarify, that as a catastrophic injury physician and attorney I care most about those permanently disabled, who represent the 1-2%. These women with pudendal neuralgia are at risk of being left behind to become indigent.
Q: Why do you say they don’t provide for the most injured?
A: To date, disappointingly, there has not been a case go to trial with what I would determine to be an adequate life care plan for a mesh injured pudendal client. That being said, the Linda Gross vs. Ethicon case, medical care was awarded at $1 million over her life expectancy and she had pudendal neuralgia. The settlements to date are a fraction of that amount. I must state I am most concerned for the most injured in this litigation.
Life care plans are individualized and designed to help provide all necessary and appropriate medical care and non-medical services for the rest of her life. If she can’t manage around the house, if she can’t work in the yard, cook, clean, and play with the kids she is left with guilt because she cannot fulfill her role as a wife and a mother. We’re trying to take the burden off so she can assume the role with the help of monetary awards.
Q: Are you able to operate on nerves so she has a semblance of a normal life?
A: A lot of women who have ongoing pain with pudendal neuralgia go to a consultation with a pudendal neuralgia specialist such as Dr. Hibner and Dr. Castellanos and get a block that provides pain relief for a short time. Some have lasting improvement for 4-6 months and they simply have another block for ongoing symptoms. But for the women who are impaired with pain, they are candidates for a neurolysis. That procedure involves her lying flat on her stomach and cutting through a portion of the sacrotuberous ligament to expose the nerve. If it is entrapped, they decompress it. If they find retained mesh and scar tissue then they decompress. Its nerve surgery and there are only two doctors in North America, Dr. Hibner and Dr. Castellanos who can deal with this certain complication and mesh.
Q: Why aren’t there more doctors to address this condition?
A: PN was so rare there are only a few centers that would address it. Pudendal neuralgia would occur in people who would squat a lot. They took care of this at the Mayo Clinic with Dr. Stanley Antolak and at Baylor Medical Center there was a program. Also at Johns Hopkins. These physicians went to France where they studied pudendal nerve surgery at Nantes. When this mesh device hit the market with no regard for the nerves of the pelvis it created a whole generation of women with PN. Simply our medical system was completely unprepared to handle it. Sadly our medical community still does not understand it.
The American Academy of Ob-Gyn should have made everyone do a course on pudendal nerve injuries. The companies that sell pelvic mesh should have made sure every implanting surgeon was educated on the worst complications of the device, which is pudendal neuralgia. Basically these women are going to surgeons who don’t understand the symptoms.
I assist women on finding a doctor with the skills to diagnose, then assists them to find a physician who can treat. Another thing that’s important is that the ‘diagnosis of chronic pelvic pain’ will often be denied SSI disability without the specific diagnosis. I’ve never had a client with pudendal neuralgia denied earned disability benefits.
Q: How are you handing your pudendal damage cases?
A: It really depends about how they are progressing with their treatments. I am optimistic that many of my clients who have been unable to obtain the care they need because of financial constraints will have greater opportunities to afford necessary care because the lending community is now understanding the value of pudendal neuralgia. It is difficult to devise a valid life care plan when care has simply not been obtained. I have women that simply in good conscience I will not recommend any type of binding arbitration going forward unless similarly injured women receive favorable outcomes. Unfortunately, to date, there have been little precedent cases to determine the market value for this particular injury.
Q: What is your assessment of the legal representation overall to date? Are you optimistic about the future?
A: Yes. The leadership level attorneys understand that they must represent everyone on their docket. They are asking for my assistance as a medical expert to review their complex cases that have symptoms and disability that would suggest a pudendal neuralgia. They are asking me to develop life care plans for their clients and analyze cases.
The path to compensation for the worst injured is perilous but for those with pudendal neuralgia there is little else to lose. Signing the Settlement terms as it stands currently affords them a lifetime of being a medical indigent. I must say that any device used for Pelvic Organ Prolapse and any Sling that offends the obturator membrane is unreasonably dangerous. The medical evidence is clear. A docket of 400 to 700 pudendal neuralgia clients is obtainable if the leadership in this litigation works together and provides a path for a timely resolution for the worst injured. The Defendants do not want to see a pudendal case in court since there is simply too much for them to lose.
Regardless of the numbers, I plan on suing the manufacturers of the transobturator slings into perpetuity until the manufacturers understand that it is not in their financial interest to continue on with the device or the FDA rings the bell with a warning to allow the manufacturers of the device to hide behind an ‘informed’ consent.
I offer services for attorneys who have or may have pudendal clients and I represent women co-counseling with leading firms on pudendal clients. This implicates all manufacturers. I’m fortunate to have met capable attorneys willing to represent pudendal clients who might decide that they must go down the difficult and perilous path of individual litigation against a pharmaceutical company.
I’m there to help women in any capacity. I’ll help their attorneys. I want women to get the care. #
http://www.meshmedicaldevicenewsdesk.com/pudendal-neuralgia-and-pelvic-mesh-serious-injury-serious-decisions/
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Reporters Resource on Covering Pelvic Mesh Issues
Jun 21, 2016 | Mesh Medical Device Newsdesk
Mesh 101: The BasicsFor reporters looking for a way to get started on the transvaginal mesh story, here are some highlights to shortcut your research.
This is not a lawyer-generated story! There are real women suffering devastating injuries from the use of plastic mesh and it continues today! 100,000 product liability lawsuits concerning transvaginal mesh makes it larger than Vioxx, breast implants and Phen-Fen all in one! Please feel free to share this information with any reporters you know.
“We were very shocked and the number of women who contacted us after the story with very similar stories of chronic pain that began shortly after surgery.”
~ Avis Favaro, Medical Correspondent, CTV National News, Ontario, Canada September, 2012
Putting a Face on Adverse Events
This story has the potential to eclipse Vioxx, silicone breast implants and thalidomide combined IMHO! There are 93,000 lawsuits consolidated in one federal court in what’s called multidistrict litigation, similar to a class action.
I’m a reporter who started looking at these issues in 2009 and could not believe what I found – the perfect storm of aggressive marketers, the doctors who are their audience, and an FDA that is largely hands-off when it comes to regulating medical devices, unlike the more stringent approval pharmaceuticals must undergo.
Injured women are told the pain is “in their head” and sent to pain management or prescribed antidepressants. There are few doctors who can do complete mesh removals or who even recognize the symptoms of mesh erosion, nerve entrapment, or the systemic effects of mesh, a permanent implant. Contrast that with the numerous implant doctors. Mesh manufacturers trained anyone who was interested in increasing revenue to their practice, in weekend cadaver clinics, despite the fact that many doctors did not have adequate surgical skills.
“It is just so unbelievable that a “minor problem” outpatient procedure that is minimally invasive causes life changing results. I know my life as I knew it is gone.”~ mesh injured patient
Reporters are amazed at the number of responses the vaginal mesh stories generate. Women who had been told they were the only one, suddenly realize their symptoms are being experienced by other women.
As a reporter you will hear stories you did not know could exist in modern medicine with few avenues for relief by those who are suffering. Men are suffering too from the same plastic mesh used in hernia repair.
Here is a guide on covering the story.Why is it Used?
Transvaginal mesh means it is placed through the vagina. This procedure called “minimally invasive” and it’s done to suspend pelvic organs that may prolapse through the vagina, a fairly common condition in women as they age, after multiple vaginal births, due to a hysterectomy, as a result of surgery or due to weak collagen. Pelvic organ prolapse is known as POP.
Many different organs can prolapse in a woman and they include:
Urethrocele– lower vaginal wall and urethra;
Cystocele-upper vaginal wall and bladder;
Uterovaginal – uterus, cervix and upper vagina;
Rectocele– lower posterior vaginal wall and rectum;
Enterocele – upper posterior vaginal wall and small bowel. POP is measured in four stages from zero to 4.
Page four and five of this FDA page shows the female anatomy and what can go wrong.
These are embarrassing conditions many women do not want to talk about. That’s why I called my original series “Suffering in Silence.” The four-part series from 2009 begins here.
Mesh is also implanted in women following a hysterectomy, sometimes prophylactically to prevent a possible future prolapse.
Another condition treated with mesh is stress urinary incontinence (SUI) which occurs when urine leaks during physical activity, coughing, sneezing or laughing. It’s estimated about 13 million American women experience SUI.
It’s estimated upward of 60 percent of women will suffer from one or both of these conditions in their lifetime and the FDA reports that in 2010 about 300,000 women had surgery to repair POP with about 3 out of 4 done transvaginally. Market data also shows that 80 percent of the 260,000 SUI surgeries done in 2010 were done transvaginally with mesh. (FDA White Paper- see below)
Transvaginal or abdominally-placed mesh for POP or SUI is intended to be a permanent implant.
One criticism of mesh often heard is that implanting it transvaginally is a “clean-contaminated” field that introduces bacteria which violates surgical protocol. An early warning about mesh came from Dr. Donald Ostergard who said mesh is not inert and reacts within the body.
See his work here:
Contraction of mesh, scarring, foreign body response, implantation of mesh in areas with ligaments, muscles and nerves continues to incite chronic pain. Many implants cannot be removed, especially the larger POP meshes with arms embedded deeply into tissues. As a result, most of these women cannot work, they lose their livelihood, their homes and their husbands.
“I’m getting booted out of my home to. and I still have at least one or more surgeries left. I pray and pray, I just hope someday this pain will not be with me anymore. I lost my husband during the middle of this, and I know this played on his death, because of his worry for me.”
What is Surgical Mesh?
Today’s mesh is generally made from polypropylene, a petroleum-based product, or is a composite of pig or cadaver biologic material.
Polypropylene is derived from petroleum and was developed in the 1950s as a thermoplastic polymer resin that can be molded into many forms. Mesh manufacturers molded the plastic into fibers for sutures. Polypropylene knitted mesh using monofilament yarns make textile fabrics and indoor-outdoor rugs.
Nine manufacturers make vaginal mesh including Johnson & Johnson (Ethicon, GYNECARE), C.R. Bard, American Medical Systems, Boston Scientific, Endo Pharmaceutical Holdings, and Covidien, among others.
Before synthetic mesh was used to hold up pelvic organs, doctors were trained to stitch up the falling organs. The main complication from this procedure is a return of the condition, but many women have been complication-free for many decades.
Synthetic mesh was first used for hernia repair in the 1950s but sometime in the 1990s it began to be used for POP and SUI. By 1996 the FDA cleared the first surgical mesh product for use in SUI and in 2002 for use in POP. The introduction of pre-cut “kits” corresponded with weekend cadaver training sessions offered by mesh manufacturers.
Gynecologists, often not trained surgeons, were schooled by the manufacturers how to implant the plastic mesh with the aid of a kit including pre-cut mesh, needles and sutures.
Almost immediately complications were noted. From 2005 to 2008, the U.S. Food and Drug Administration noted it had received more than 1,000 reports of complications associated with mesh.
They can include:Erosion through the vaginal epithelium and tissues;Infection;Perforation of bladder, rectum,Urinary problems;Internal bleeding;Recurrence of prolapse and/or incontinence;Vaginal wall narrowingNerve entrapmentVaginal scarring;Dyspareunia (painful sexual intercourse)Death“I’m so tired from the struggle & the wait for proper medical attention. My heart is growing weary after five years I am getting worse & scream out to even get up & set down . The getting up is worse , I draw double holding my lower abdominal area where there is an open hole that bleeds.”
By October 2008 when the FDA issued a Public Health Notification (PHN) concerning transvaginal mesh, it said there were more than 1,000 reports of adverse events, as the FDA calls complications. The events were serious but “rare,” according to the FDA. FDA 2008 Public Health Notification here.
Then in July 2011, the FDA (here) reported that complications associated with transvaginal mesh to treat POP increased five-fold; that “serious complications associated with surgical mesh for transvaginal repair of POP are not rare” and that transvaginal mesh used for POP repair “does not improve symptomatic results or quality of life over traditional non-mesh repair.”
The FDA issued a White Paper “Urogynecologic Surgical Mesh” about the same time which is an excellent resource here.
It was after this point that lawsuits began to be filed.The Problems: A Safety Loophole
A little known loophole buried deep within the administrative jargon of the Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) is called the 510(k)process. The process is used to fast-track the marketing of low to moderate risk medical devices such as wheelchairs, tongue depressors, latex gloves, Class II devices such as catheter, blood glucose monitors and surgical mesh.
No pre-market review is required for approximately 3,000 medical devices approved by the CDRH every year. That means no clinical trials must be presented to assure safety and efficacy unlike the pre-market approval (PMA) process pharmaceuticals must undergo.
Unfortunately with the explosion of medical devices, permanent implantable and high-risk devices are also approved via 510(k). All the device maker must do is name a “predicate device” currently being sold that the new device resembles.
The “substantial equivalent” standard has allowed thousands of medical devices to flood the market with no clinical trials.
DePuy metal-on-metal hips, defibrillators, pacemakers, synthetic transvaginal mesh and hernia mesh are all approved via 510(k). Last year, the Institute of Medicine (here) called 510(k) “fatally flawed” and called for the outdated process to be abolished.
The FDA discussed the IOM report in a September 2011 meeting. The transcript is here:
The recalled ProteGen Sling has served as a predicate device for most of the meshes on the market today. A great resource on the ProteGen predicate was done by a mesh injured woman who I’ve found to be very credible and an excellent researcher. It appeared on iCNN here:
See Diana Zuckerman from the Center for Women and Families, and her excellent piece on 510(k) published in the Archives of Internal Medicine here.
The FDA has a limited budget to conduct medical device reviews as it receives much of its funding from Congress. Some of our representatives feel strongly about the “constituents,” namely the medical device industry, especially in states that have a thriving medical device industry.The Problems: Recalls
Even today women are often told the bad mesh is off the market. In most cases this is misleading because the vast majority of meshes are still on the market.
In June 2012, Ethicon (Johnson & Johnson) announced it was discontinuing the sale of four synthetic transvaginal meshes from its Gynecare division. Here is background story from Mesh Medical Device News Desk.
Further evidence the FDA bends to the wishes of industry – The Food and Drug Administration Modernization Act of 1997 narrowed the array of issues that the FDA may consider in a 510(k)review, and directed the FDA to limit, to the “least burdensome” level, the scientific evidence requested to determine substantial equivalence of devices that involved new technologies. That means least burdensome to industry, not to the patient who might be adversely impacted by a defective medical device.
In 2012, Rep. Ed Markey (D-MA) tried to close that loophole with his Sound Devices Act, which would not allow a recalled medical device to serve as a predicate. The Sound Devices Act, supported by Consumers Union, was overwhelmingly defeated by a congressional committee.
Here is a Bloomberg story on using predicates to approve new meshes.
The FDA did attempt to play a little catch up in January 2012 when it ordered about 35 mesh manufacturers to do three years of complication follow-ups on women who have been implanted with mesh. These are called 522 studies and the FDA has limited authority to order the studies when a medical device appears to be injuring patients. At this writing, more than three years later, those 522 studies are in limbo and have not been completed.The Problems: No one is Watching
No one.
There is no national medical device registry in the U.S. Essentially your automobile’s VIN # is a better example of how an industry can follow-up when there is a problem. That system does not exist for medical devices at the present time and in the U.S. no one is gathering data at the present time on medical devices when they fail to perform as intended.
Australia has a form of post-market surveillance and it’s no surprise that that country was the first to understand that DePuy (Johnson & Johnson) metal-on-metal ASR hip implant was failing because of the many reports coming in. DePuy ASR was later recalled but not before thousands more patients received the implant.
The Problems: No Idea of the Scope of Injuries or Complication Rate
This is another mystery.
The FDA reported in July 2011 that from Jan. 01, 2008 through Dec. 31, 2010, it received 2,874 additional reports of complications associated with surgical mesh devices used to repair POP andSUI, with 1,503 reports associated with POP repairs and 1,371 associated with SUI repairs.
But reporting an adverse event by the manufacturer is largely voluntary as the manufacturer can decide if the injury is mesh-related or not. The MAUDE database within the FDA (Manufacturer and User Facility Device Experience) is where a woman or her doctor are supposed to report complications. The actual reported number are thought to represent about 1 percent of real life injuries, according to a government report. That’s because the database is little known, and difficult for a patient to navigate.
Here is a MDND story on How to Report an Adverse Event:
(Suffering in Silence- Part 1) finding data on Ethicon’s Gynecare Tension Free family of mesh products involves knowing the criteria:
1.) Product Class: Mesh, Surgical, Polymeric (You will have to scroll through the M’s to find this phrase.)
2.) Brand Name: Tension Free
3.) Date Report Received by the FDA: (Date Range) 05/12/1999 to Current Date.
4.) Records Per Report Page: Change to 500 and click Search.”
Without tracking and with few finding the FDA’s MAUDE database and entering their device numbers, there is no way to really know how many women are really suffering complications from transvaginal mesh.The Problems: How Women are Treated
POP and SUI are considered “conditions” and are an inconvenience, generally not painful, but are embarrassing. Most women do not talk about the condition and many find it embarrassing even to talk about complications that result from surgery.
That may be one reason the surgery option continues today; women are embarrassed to speak to their doctor about complications; symptoms may be general in nature and they may not associate the symptoms with mesh; and doctors who receive their primary education from the mesh makers and their representatives, are not equipped in the majority of cases to handle complications.
Women suffering after a mesh implant often hear, “you’re the only one who is having these problems.” Women suffering complications are frequently told they are depressed and told to visit pain management and to take antidepressants. Many women talk of suicide. Some wish they would get cancer, at least it would be a confirmed medical condition.
These stories are repeated over and over. #
http://www.meshmedicaldevicenewsdesk.com/reporters-resource-on-covering-mesh-issues/
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Jun 21, 2016 | Wisbech Standard
By Kath Sansom
A mesh sling surgically implanted to cure women suffering embarrassing leaks, usually caused by pregnancy, has been criticised for causing serious complications, pain and discomfort.
The National Institute for Health and Care Excellence, NICE, which sets guidelines for care in hospitals across Britain, said the mini sling should not be used unless there are proper plans in place for follow up care if things go wrong.
The report by NICE, which is still under consultation, said:
• Data collection on mini slings was “disappointing” and there needs to be further research and long term studies
• Mini slings should not be used unless there are special arrangements for following up a woman’s care
• If a surgeon implants mesh as part of a trial patients must be fully informed of “the uncertainty” over safety including the potential for “serious long term complications.”
• All women having mini slings must be added on a national register held with a professional body like the British Society of Urogynacology.
• Surgeons trialling mini slings must tell their NHS Trust bosses
The report has been welcomed by UK campaigners in Sling the Mesh and Scottish Mesh Survivors who are delighted that complication concerns are being taken seriously.
Sling the Mesh campaigner Kath Sansom said: “None of the mesh slings used today have been given long term human trials and none of them have been properly studied for the impact on how they can greatly impact on a woman’s quality of life with risks including losing a sex life forever due to pain, chronic infections, allergic reactions and pain walking.”
Olive McIlroy of Scottish Mesh Survivors said: “The uncertainty about the procedure’s safety and efficacy speaks for itself.
“The potential for the procedure to fail and for serious long-term complications is an unacceptable risk for even one patient and merits an immediate cessation of this and similar pelvic polypropylene mesh procedures.
“The best thing NICE can do is introduce a mandatory independent registry to follow existing patients and then act on the long term data.
“All polypropylene mesh devices should be kept out of operating theatres, that would ensure patient safety.”
Mini sling trials began two years ago when Scotland suspended two other styles of plastic mesh sling in June 2014.
Scotland is waiting for its final report into mesh slings, due out this summer.
In the meantime, mini sling trials have begun in hospitals across England – locally trials are set to start at the Queen Elizabeth Hospital in King’s Lynn.
Across Britain hospital bosses look to NICE guidelines as the benchmark for how they run services and treat patients.
If a NICE report is critical then it is unlikely a hospital would wish to fly in the face of its recommendations.
The mesh mini sling guidelines are currently in the consultation stage and are set to be approved in September 2016.
http://www.wisbechstandard.co.uk/news/mesh_mini_slings_cause_serious_complications_and_research_into_their_use_is_disappointing_says_report_by_nice_1_4587037
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Jun 21, 2016 | UroToday
By Manabu Nishibayashi, Koichi Kobayashi, Akinori Miki, Ryugo Okagaki, Ichiro Nagata, Mitsuyoshi Urashima, Osamu Ishihara
To study the correlation between stress urinary incontinence (SUI) and the mobility and funneling of the bladder neck (BN) by observation of pre- and postoperative course by perineal ultrasound (PUS).
We investigated 123 cases that underwent reconstructive surgery for pelvic organ prolapse (POP). We prospectively checked bladder neck mobility (BNM) during the Valsalva maneuver and funneling of the BN at rest by PUS. We defined the width multiplied by the depth of the funnel-like profile of the BN as the funneling index (FI). We checked BNM, FI, and the presence of SUI just before the operation, and we checked the postoperative course of BNM and SUI.
When BNM was ≥10 mm before surgery, the odds ratio for accompanying SUI was 2.68 relative to BNM <10 mm (p = 0.031). When FI was ≥150 before surgery, the odds ratio for accompanying SUI was 4.12 relative to FI <150 (p = 0.004). Although postoperative BNM values were significantly improved immediately after surgery, they gradually increased within 2 years. Among the cases with preoperative SUI, the recurrence rate was significantly higher in the patients whose FI was <150 (p = 0.019).
Our results yielded by PUS suggested that larger BNM and FI values were the causative factors of SUI. PUS may be beneficial for selecting a suitable surgical procedure for POP, and it may also be helpful for assessing surgical efficacy.
Journal of medical ultrasonics (2001). 2009 Aug 25 [Epub]
http://www.urotoday.com/categories/1165-pelvic-organ-prolapse/89397-bladder-neck-evaluation-by-perineal-ultrasound-before-and-after-reconstructive-surgery-for-pelvic-organ-prolapse.html
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