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FDA to Consider Reclassifying Trocars Used to Place Surgical Pelvic Mesh
Mar 14, 2016 | Mesh Medical Device News Desk
By Jane Akre
...The U.S. Food and Drug Administration (FDA) has received 463 reports of instrumentation causing injury during an implant – from piercing an organ such as a bladder or urethra, to damage to blood vessels and nerves and other connective tissue, adverse tissue reaction, infection, nerve impingement, a needle detaching, and excessive bleeding. Boston Scientific (316) and Ethicon/ Johnson & Johnson (90) had the two highest number of adverse event reports, according to an FDA report. -
Noni Wideman to Consumers Union Concerning Pelvic Mesh
Mar 14, 2016 | Mesh Medical Device News Desk
By Jane Akre
...An Ethicon brochure for doctors regarding their product said an underlying autoimmune disorder is a contradiction for use. With a historic record of not telling the whole truth and down playing risk it makes patients researching wonder what else Ethicon did not tell us about the links between autoimmune problems and their mesh products? -
Device-maker Coloplast is 'building on strength'
Mar 14, 2016 | Star Tribune
By Joe Carlson
...Since then Coloplast has become one of the half-dozen med-tech companies facing thousands of lawsuits from women who say they were injured by a group of medical devices known as vaginal meshes and slings for treatment of pelvic organ prolapse and incontinence. That litigation is ongoing. -
Serious unboxing: 230 node research cluster down under
Mar 15, 2016 | The Register
By Richard Chirgwin
...Dr Gunasegaram says in Dell's canned statement that computer simulations are helping the agency's work on nylon mesh for use in pelvic organ prolapse (POP) surgery, something required by one in five women at some point in their lives. -
CSIRO and Dell supercomputer to mothers’ rescue
Mar 15, 2016 | The Australian
By Chris Griffith
...“Current mesh implants that haven’t been well designed for this purpose can lead to pain and discomfort, so we’ve teamed up with researchers from Monash University to develop an improved mesh for supporting prolapsed organs and treating the condition more effectively,” Dr Gunasegaram said.
Client Attorney Privileged/Attorney Work Product/At Request of Counsel
Online Sources
Full Text of Stories Below
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FDA to Consider Reclassifying Trocars Used to Place Surgical Pelvic Mesh
Mar 14, 2016 | Mesh Medical Device News Desk
By Jane Akre
hen mesh kits were first developed and marketed in the U.S. in the mid 2000’s, they came complete with precut mesh and what’s known as a trocar.
What are trocars?
A trocar is a stainless steel needle attached generally to a plastic handle that resemble hooks. A capio is a needle used for transvaginal POP (pelvic organ prolapse) procedures. If you watch a video of a transvaginal mesh implant here (careful, these are disturbing) you will see the device threads the mesh and captures it at the other end in a blind procedure.
Trocars pass near arteries, nerves, tissues and organs.
A doctor will feel or palpate the anatomic landmarks to “access critical ligaments and attach anchors and other devices needed to secure the mesh,” according to the FDA.
Trocars have remained in a FDA classification with Band-Aids and wheelchairs- that is classified as unlikely to cause patient harm, even though they are used internally.
Now, the agency is considering whether to bump up the classification to class II, or moderate risk and adding special controls for the use of urogynecologic surgical mesh instrumentation designed to be used with urogynecologic surgical mesh. General instrumentation will remain in class I.
The U.S. Food and Drug Administration (FDA) has received 463 reports of instrumentation causing injury during an implant – from piercing an organ such as a bladder or urethra, to damage to blood vessels and nerves and other connective tissue, adverse tissue reaction, infection, nerve impingement, a needle detaching, and excessive bleeding. Boston Scientific (316) and Ethicon/ Johnson & Johnson (90) had the two highest number of adverse event reports, according to an FDA report.
The FDA searched MDRs (Medical device reports) it had received from January 1, 2008 to December 2, 2015, to determine those associated with urogynecologic surgical mesh instrumentation.
Note- the FDA removed those reports that contained the terms attorney and/or plaintiff, “as such reports typically contain few details and stem from patient litigation.”
EXPERT PANEL CONVENED
On February 26, the FDA convened an expert panel, Gastroenterology-Urology Medical Devices Advisory Committee Panel, to first, define a trocar, review the 463 adverse event reports and decide whether they should be reclassified. The FDA usually follows the recommendation of its expert panels.
This is the third step of the reclassification process. The agency received public comments May 1, 2014, proposed the reclassification in a 513€ proposed order. Convening the panel is the third step before reclassification.
The FDA received just 13 public comments related to reclassification following the publication of the May 1, 2014 proposed order. Six of those comments supported reclassification. A consumer group commented that urological surgical mesh instrumentation be reclassified as class III, the same as mesh for pelvic organ prolapse.
The FDA believes that the risks associated with urogynecologic surgical mesh instrumentation (accessory device) can be mitigated through special controls; and accordingly, the FDA believes class II is the most appropriate regulation for these devices.
As evidence that the FDA follows the lead of manufacturers, the manufacturers are the final word on whether their own trocars contributed to the injury/damage. “Unable to Confirm Complaint,” is the most frequent response. Adverse event comments made to the FDA also concerning pelvic and hernia mesh also rely on the final assessment by manufacturers as to whether their device/ instrument led to the injury.
Interesting to note* – the FDA found that there were far more patient complaints lodged against instrumentation used for SUI mesh implants, rather than POP mesh, yet the FDA is only reconsidering reclassifying POP mesh as class III.
ADVERSE EVENTS
The FDA report notes between 1997 and 2015, there were 255 published reports outline adverse events with respect to pelvic mesh surgery, this could involve a problem with the surgery including or not the type of surgical instrumentation.
The adverse events included organ perforation, injury, urethral injury, bladder injury, bladder perforation, rectal injury, hemorrhage, vascular injury, hematoma, nerve injury, nerve damage, leg pain, thigh pain, buttock pain, other pain, abscess, infection, cystotomy, enterotomy, blood transfusion and neurologic symptoms.
The adverse events range from less than one percent to more than 39 percent. ##
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Noni Wideman to Consumers Union Concerning Pelvic Mesh
Mar 14, 2016 | Mesh Medical Device News Desk
By Jane Akre
Noni Wideman, a survivor of a polypropylene mesh implant, writes the following letter to Consumers Union. CU and specifically Lisa McGiffert have been involved in the pelvic mesh issue through Safe Patient Project, proposing that medical devices carry a warranty not unlike the refrigerator you buy. Makes sense!
email sent March,12, 2016
Washington DC Office
Consumers Union
1101 17th Street NW, Suite 500
Washington, DC 20036
Phone: (202) 462-6262
Fax: (202) 265-9548from Nonie Wideman
I am an advocate for women with medical mesh implant injuries.
My heart almost skipped a beat when I read the following: “Consumers Union is the policy and action division of Consumer Reports. We work with our million plus activists to pass consumer protection laws in states and in Congress. We hammer corporations that do wrong by their customers, and encourage companies that are heading in the right direction.”
Boy, oh boy! I urgently need your help to hammer some corporations and entities that have done wrong to their customers, done wrong to the patients they were supposed to protect. I have been tweeting, along with other women harmed by dangerous medical implant materials and devices, #FDA#JNJ#HARMS#WOMEN.
I’m filled with hope that the Consumers Union can change the worst flagrant intolerable marginalization of women’s healthcare since the dark ages.
Tens of thousands of women have come forward in the past three years to report significant harm done to them when implanted with dangerous, medical mesh products to treat prolapse (POP), stress urinary incontinence (SUI), hernias, and thousands of young women have been implanted with Essure sterilization coils. I would be remiss to not include the men, who also have been harmed by the hernia mesh products. Millions of men and women have been implanted with synthetic mesh for hernia repair. It is the most done surgery. Over 300,000 women have been treated for POP and SUI per year in recent years. Most of the repairs are done with synthetic surgical mesh. Essure coils have killed women, fetuses, and caused need for too many young women to have hysterectomies.
The systemic response to coils are causing autoimmune disease symptoms in these young women. Polypropylene mesh implant complications have killed women. The pain from mesh complications has caused suicide, suicidal depression, perforations into other organs, erosions, extrusions of mesh out of vaginas, adhesions, and like in the group of 20,000 Essure harmed women, the systemic response to the mesh complications have caused higher rates of autoimmune symptoms and confirmed autoimmune diseases post mesh complications.
Adverse events caused by medical implant materials and devices are notoriously under reported. One would think with over 100,000 lawsuits over transvaginal mesh tapes (TVT) and materials, there would be 100,000 adverse events reported to the FDA, reports made by primary care givers and surgeons.
The numbers of mesh cases in litigation far exceeds the number of adverse event reports. We all know the reasons for under reporting. (It’s called ass covering.) It’s to avoid responsibility, avoid litigation. It is also ignorance, misdiagnosis that causes under reporting. The true number of mesh injuries will never be known, because it was not mandatory to report every problem attributed to mesh implants.
Reporting is discretionary and subjective to interpretation. Doctors who are not trained to look for damaging chronic foreign response to these implant materials, seldom recognize or understand the ongoing foreign body driven injury inside their patients bodies. Women in pelvic pain have been sent to psychiatrists, when, what they really needed was a urogynecologist to remove their degrading, folding , nerve entrapping, shrinking, biofilm covered infected mesh implants.
Arrogance by the medical community to listen to the voices of those most impacted by the adverse events occurring after being implanted with non-inert PP mesh is rampant. Arrogance, by the FDA to admit women know more about their own body’s response to mesh far exceeds the knowledge that many of the surgeons who implanted the synthetic mesh have, is insulting. We do not need patriarchal platitudes and condescending attitudes. We need protection from poorly, and understudied, and often untested permanent implant materials being allowed on the market by the faulty 510K process.
The FDA reclassification of transvaginal mesh for POP repair to a class 3 needing premarket approval (PMA) is a step in the right direction.
This reclassification proposal came too late, and does not go far enough to protect all women with transvaginal mesh implants. More than half the litigation over mesh is for the SUI mesh, and yet the FDA in its lack of wisdom failed to include SUI mesh products in the reclassification.
Patient’s voices should be heard above those that stand to continue to profit from the use of poorly tested, understudied defective mesh products. If a product does not remain inert in all of the people it is implanted into it must be considered defective as it does not perform as intended. If an implant product can degrade and leach chemicals into the host body, that is not acceptable and it should be considered defective. Furthermore if no other biocompatible tissue scaffolding material is available to use to benefit a patient, the synthetic implant material or device should be considered a high risk material or device.
Polymeric SUI mesh products degrade and fragment exactly the same way POP mesh implants do. They are made of exactly the same polymeric materials. When looking at all the uses of polypropylene mesh materials and noticing that close to 30% in each type of use, (for SUI and POP repair) have complications it is apparent that a large subset of the population are hypersensitive to synthetic implant materials and it would seem necessary to do more studies and testing to see what biomarkers this group of patients have that puts them at a higher risk of complications.
An Ethicon brochure for doctors regarding their product said an underlying autoimmune disorder is a contradiction for use. With a historic record of not telling the whole truth and down playing risk it makes patients researching wonder what else Ethicon did not tell us about the links between autoimmune problems and their mesh products?
What makes the injury of SUI mesh patients less disastrous than those with POP mesh implants that go wrong? Granted the women with POP mesh implants have more product implanted but the response when you are “allergic” to the implant material is equally painful, and quality of life destroying even with a smaller quantity of an allergen inducing product. If you are highly allergic it matters not the amount of allergen.
Consider a bee sting, for a hyper-reactive person, one sting can kill you. You don’t need two dozen bees to sting you to die, you just may die faster. If your body is hypersensitive it really does not matter that the piece of polypropylene is large or small. A person that is chemically sensitive with a SUI mesh may have more problems than a less sensitive patient with a larger amount of mesh. I urge you to not exclude SUI mesh from this proposal.
The polymeric meshes degrade in different parts of the body in the same way, no matter where placed or the skill of the surgeon when it is the host response to the properties of the mesh that cause the cascading complications. However I would dare say the mechanical irritation of mesh in a constant wound created by FBR in a vagina and pelvic floor may be harder to endure than the abdominal pain of hernia mesh contraction and nerve entrapment.
I have not had a hernia repair with synthetic mesh, but I can testify to the excruciating pain of a SUI, TVT Secur implant eroding into my urethra and bladder and extruding from my vagina. I can testify to the lack of skill of doctors to recognize and diagnose the complications in a timely fashion to prevent permanent nerve damage. I can testify to the fear you feel when your urine contains blue fibers and your urethra feels like it is on fire and the tests for infection come back negative. Three years of cascading systemic health problems post mesh implantation, then 8 months of excruciating constant pain, nine doctors later I had the mesh removed. I live with pain every day. There was no transient foreign body reaction. The foreign body reaction was constant and it increased with time. I begged the FDA to not exclude SUI mesh from reclassification. I provided studies and facts and figures.
The scar tissue created by mesh is proven to entrap nerves causing often irreversible pain. Doctors know this, the FDA knows this. When the nerve damage (compression, erosion, chemical and mechanical irritation) is to the sensitive pudendal nerves that impact sexual function, urinary function, and bowel function, the results can be catastrophic. The foreign body response to mesh experienced by the large cohort of patients that are hypersensitive to foreign body implants does not appear any different in hernia patients, POP patients, or SUI patients. Nor is the foreign body response to Essure coils any different.
The mesh contraction in hernia mesh products, POP mesh products, SUI mesh products, is the same. The leachates from polymeric meshes, such as the hydroxyls are the same, the free radical damage from the degradation of PP mesh is the same, the loss of quality of life is the same. I urged the FDA to not exclude SUI mesh from reclassification to level 3.
I urged the FDA to, in the very near future, to consider adding hernia mesh to class 3 also. If there is no reason for doctors to change their perception of the safety of synthetic mesh there will be no hurry to find alternative structural support materials that are more compatible.
Class 3 status for synthetic mesh implants, or any permanently implanted device or material in the minds of most mesh complication victims is a compromise. It is not a ban on the implant materials, which many feel is appropriate, but a compromise. It would be an added safety feature that makes scrutiny more intense on what patients will benefit from the use of the synthetic meshes and those that will be harmed more than they will ever be helped.
If the FDA continues to view these permanent implant devices and materials in the same class as syringes shame on them. It does not take a scientist to figure out there is a difference between the stability of a product to remain inert and be biocompatible in the body of the patient it is implanted into, and the functioning of products not permanently implanted into people. There are more safety warnings about drugs that can be immediately withdrawn than there are for medical device implants that are nearly impossible to remove, taking many surgeries to remove, causing horrendous costs in pain and suffering to patients as well as the added costs to the health care insurance providers.
The FDA failed to act fast enough to prevent injury to the 30% of patients who have experienced adverse reactions to synthetic mesh implants. It is common knowledge that the mesh complications are under reported and minimalized. Women are just now educating themselves as to what has happened to them. Most women have had to self-diagnose their pelvic pain and then fight to have doctors listen to them and act upon the information they have brought to their doctors . Too many doctors do not recognize the first symptoms of chronic FBR and they are unprepared to manage the complications with skill and expediency. That is a shameful response to the warnings the FDA put out to the medical community. The warnings were not strong enough.
Far better it would be if patients were the first ones notified when warnings come out about the devices or materials put into them, put into them with permanence as an objective, with no protocol on how to monitor the performance of the materials or devices. Patients when notified could take their product info to their primary caregiver and then scrutiny could and should follow.
The person who has the most to lose or gain would following up on warnings, not the persons on the defence for using risky materials before benefit over risk was established. The car manufacturing business has better recall features that the medical community does for defective parts and implant materials. The FDA must be forced to classify all permanent implants as class 3 products. It is common sense.
The manufacturers of medical implant materials have profited from the sales of these products and therefore need to bear the cost of testing and studies. Right now, hundreds of thousands of patients are bearing the cost of inadequate testing and researching, and fast tracked products based on predicate devices that were recalled. The cost these patients pay, that hurt the most, are not measured in dollars , but in pain, loss of life, loss of quality of life, loss of independence, relationships and the most valuable of assets loss of health and happiness. The families of these patients suffer along with them. To not include SUI mesh products in the reclassification proposal was abysmally wrong.
Mesh is mesh is mesh.
Biomaterials have been proven to have an adjuvant effect. When foreign body reaction is expected to be transient there is an expected end to the foreign body reaction process and an acceptance or tolerance of the biomaterial. There are no studies that investigated the consequences or impact to the patient when their autoimmune system is activated constantly by chronic foreign body reaction that is strong enough to degrade an implant device or material and cause device failure.
Causal evidence is piling up to link chronic foreign body reaction causing mesh complications to the development of autoimmune disease in the cohort of patients who have hypersensitive immune systems. When you have no protocol to test for hypersensitivity, and it is not suggested to test for sensitivity, not suggested by mesh manufacturers as due diligence when discerning which patients it is a gamble to implant with synthetic materials, or which patient it appears to be safe for, it just another logical reason why all transvaginal synthetic products need to be class 3.
We must not allow the FDA to exempt SUI implant materials from the class 3 proposal.
When there are concerns that the leachates from polypropylene mesh degradation may have an estrogenic effect in the human body, the effect of estrogen on some estrogen driven cancers is more than disconcerting. Inflammation, stress, toxic chemicals, and infection, are all linked to autoimmune pathogenesis. How many mesh complication patients do not have erosion, extrusions, infections, pain, stress, chronic inflammation, and chronic wounds around mesh? What is the acceptable rate for complications?
When I was told complications are rare for this minimally invasive procedure, I calculated the risk as the same as winning the lottery. The benefits appeared to outweigh any distant rare warnings. Rare? Obviously the studies were not adequate and this underscores the necessity of reclassifying any permanent implant device or material as class 3. I trusted my doctor, and I believe he trusted the manufacturers.
The FDA is abundantly aware of the loopholes in its 510 k system. When a product is recalled all the subsequent products substantially equal to the predicate device should be recalled also. For if they are substantially equivalent it stands to reason they are substantially defective. Each permanent implant by virtue of the permanency factor should only gain clearance by the FDA by virtue of its own properties, where long term studies have proven benefit over risk, where cytotoxicity, and biodegradation tests will indicate the materials will stay inert invitro for the life expectancy of all the patient implanted with the material or device, not just 70% of the patients.
When researching I found out these lifetime permanent products for patients have a shelf life expiry date. If these products have a shelf life expiry date what does this tell patients? If the products crumble and fray before they are implanted, as has been discovered, how did doctors and manufacturers expect the material to withstand the oxidative process of the human body when it will not accept the polypropylene mesh, and tries constantly to degrade and expel it?
Why is it patients are not privy to what chemicals and additives are in the implant materials in their bodies? Does the FDA even know what chemicals are leaching out of polypropylene? When many women with mesh complications are being diagnosed with Lupus and other autoimmune disorders post mesh implantation at a higher rate than the general population we have a right to know what our bodies are reacting to and exposed to.
Adjuvants have caused autoimmune disorders. Biomaterials have been proven to have an adjuvant effect. Studies should have been done regarding this and they need to happen now, because these types of studies didn’t happen when they should have, before the products were cleared by the FDA. This is why polymeric biomaterial meshes need to be reclassified to level 3. What difference is there between the FBR to SUI placed mesh and POP placed mesh? None except for perhaps abdominally placed mesh would be less likely to be contaminated.
The vaginal placement of transvaginal mesh is a clean contaminated field. SUI placed mesh is inserted into this less than pristine environment and therefore it may be subject to more chance of infection than abdominally placed meshes, so I argue that SUI meshes need to be included in the proposal for class 3 status and regulations. When meshes have biofilms that cause a chronic infected state is it any wonder immune system get exhausted and adrenal fatigue is common for patients in constant pain?
I believe it is safe to say hundreds of thousands of women are sharing research, information and experiences with brutal honesty. They feel violated, like a group of misogynists invented mesh to torture them. Social media is a powerful tool and as more and more women globally join forces and dig deep into medical journals and abstracts and reviews there is a growing anger at what has been allowed to continue for too long. We expected better from the FDA. We deserved better from the FDA.
Any suspected adverse reaction to an implant material or device should be mandatory to report. When patients report adverse reactions and there is no number to match by doctors there should be a review of the patient’s doctors. Self-protectionism by doctors is not acceptable at the expense of patient’s health and lives. If mistakes and concerns are not reported we cannot learn from them. We cannot fix what do not realize is happening. There is a disconnect between patients of specialists, because after surgery, and consultations, patients return to their primary care givers who may not be aware of what to monitor and watch for.
I believe the manufacturers of mesh implants are the first to blame for our misery, the FDA is the second to blame, the doctors the next to blame. For such a highly educated group of professionals to allow such an unacceptable situation to go this long, allowing so many lives to be harmed, is hard to forgive let alone comprehend.
It is my belief it is the duty of the FDA to err on the side of caution and classify POP mesh, and SUI surgical mesh as level 3 products. Furthermore I believe millions of hernia mesh patients would support classifying surgical mesh for hernia procedures be classified at the same level. The FDA needs to be forced to use its power to protect patients first and foremost. A half measure discriminatory safety net is not good enough.
Your sincerely Nonie Wideman,
voice for Canadian Victims of Transvaginal Mesh
advocate for medical mesh complication patients in BC Canada
moderator for Links on Mesh forum, 1015+ members
creator of Links to Medical Mesh Research www.meshproblems.weebly.com
contributor to Medical Mesh Device News Desk website
research contributor to TVT NO Org.
Survivor of TVT Secur complications
author of The Links Between Surgical Mesh Complications and the Development of Autoimmune Disease
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Device-maker Coloplast is 'building on strength'
Mar 14, 2016 | Star Tribune
By Joe Carlson
After a period of adversity, the medical device company Coloplast is trying to get back to the strong sales growth it has enjoyed for much of its past.
The company has tried to reach health care consumers directly with slick ads for its SpeediCath urinary catheter on television and Facebook, while also investing behind the scenes in its sales efforts around the country. Coloplast will mail out product samples to consumers who apply, and have one of its call-center workers in Minneapolis counsel users on using the device, step-by-step.
Sales growth for the higher-priced Speedicath urinary catheters is a key component of the Danish company's growth strategy in the U.S., which itself is a linchpin to regaining some of the global market confidence that Coloplast may have lost after a challenging fiscal 2015.
"We see the U.S. as a tremendous global growth driver," including daily use, chronic-care devices like the SpeediCath and the SenSura Mio line of ostomy products, said Coloplast North America President Ed Veome. He made the comment during a recent interview at the company's U.S. headquarters overlooking the Mississippi River in north Minneapolis.
The market is watching closely. Barclays analysts noted in February that market stabilization and strong organic sales growth in the U.S. will be key issues in 2016 after recent market disruptions, including a Justice Department investigation of several companies that resulted last December in Coloplast paying a $3 million settlement without admitting any wrongdoing for sales practices.
"The U.S. market is normalizing, even if this may take a few more quarters to materialize," a February investors' note from Barclays said.
Coloplast was founded in Denmark in 1954 by a nurse who saw the negative effects on her sister after she had an operation to reroute her intestine to a surgically created hole in her skin called an ostomy, which is connected to an external pouch for removal of bodily waste. Though the company has grown tremendously over the years, it remains focused exclusively on devices to treat what it calls "intimate health care needs."
It will derive about three-quarters of its projected $2.2 billion in revenue this year from sales of daily-use devices for ostomy and continence care, made primarily in France. The remainder of the revenue will come from surgical urology devices like penile implants and surgical mesh implants for women's pelvic health, all made in Minneapolis, and wound and skin care products made in Mankato.
Although Coloplast has historically relied on internal innovation rather than acquisitions for growth, it bought Mentor Corp.'s urology business in 2006 for $463 million. That deal triggered a decision to raze Mentor Urology's old building in north Minneapolis and bring Coloplast's U.S. headquarters and urology manufacturing operations to a shiny new energy-efficient building on the same site.
"With Minneapolis being a medical device capital in the U.S., it was quickly decided that it made sense to put the headquarters right here," said Vice President Jim Schumer.
Since then Coloplast has become one of the half-dozen med-tech companies facing thousands of lawsuits from women who say they were injured by a group of medical devices known as vaginal meshes and slings for treatment of pelvic organ prolapse and incontinence. That litigation is ongoing.
The company also weathered some negative headlines after deciding to pay back Minneapolis more than $600,000 in public incentives for failing to meet job-creation benchmarks in the new building under a deal that had been structured just before the Great Recession hit. And in the United Kingdom, a temporary distribution problem in 2015 caused a loss of market share that the company is still working to win back.
Yet Coloplast has long been revered among analysts for delivering steady margin expansion and high organic sales growth rates, said Jefferies & Co. analyst Chris Cooper.
"From a stock price perspective, they were a darling of the sector for years," Cooper said via e-mail. "We analysts regularly underestimated profits, and so during the course of a given year the share price would be driven upward by frequent upgrades to forecasts. However, we are now in a more uncertain time where margins have been flat for two years and earnings revisions are beginning to turn more negative."
Coloplast posted 7 percent organic revenue growth in the most recent quarter, and a 33 percent operating margin on about $500 million in revenue. It is projecting 7 percent organic growth in the year that will end in September.
Morningstar analyst Debbie Wang said Coloplast's approach to thoughtful, user-friendly design is likely to help the company win over customers from competitors like ConvaTec and Hollister.
"We are big fans of the ostomy and continence care businesses. … Patients are fairly loyal and they appreciate thoughtful design, and reimbursement has generally been moving in the direction of 'more generous,' " Wang said in an e-mail. "Even though Coloplast is a latecomer to the U.S. market, we think American [patients with ostomies] will be receptive to Coloplast's well-designed products."
That's why Coloplast executives say the path to success for them depends not on blockbuster deals or product-line diversification, but on putting their well-liked products in the hands of more people.
That goes particularly for products that are popular overseas but still making inroads in the U.S., like the SpeediCath.
"For us, it's a lot about strengthening the infrastructure," said Coloplast Senior Vice President Steffen Hovard. "We are building on strength. It's not based on white elephants we need to go find in the jungle. We actually have the products available in the portfolio that allow us to partner and work even stronger with the physicians that we already are working with."
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Serious unboxing: 230 node research cluster down under
Mar 15, 2016 | The Register
By Richard Chirgwin
Australia's Commonwealth Scientific and Industrial Research Organisation (CSIRO) has run up a 230-node cluster from Dell to support its data-intensive and computational modelling research activities.
The core of the machine, dubbed "Pearcey", is a bunch of PowerEdge M630 blades with 128 GB RAM each, and four R930 PowerEdge nodes with 3 TB of memory each.
Sixteen of the M630 blades come with extra memory – 512 GB each – and Dell's ScaleMP software presents them as a single 8 TB cluster running a single OS image. There's Mellanox FDR InfiniBand networking connecting it all together.
The M630 is a Xeon E5-2600 v3-based unit, and when the blades – list price more than US$18,000per if you're a casual shopper on the Dell site – are loaded with two processors, each blade can have up to 36 cores.
Dell APJ's High-Performance Computing manager Andrew Underwood says the Pearcey machine has come from “more than three years of close collaboration with CSIRO’s Information Management and Technology team”.
Dell's probably pleased about the three-year gestation of the project, since it didn't expose the project to the seemingly-random budget cuts that have infested the rest of CSIRO since 2013.
Target applications include bioinformatics, fluid dynamics and materials science, CSIRO says.
CSIRO computational modeller Dr Dayalan Gunasegaram explains that the “thousands” of processor cores available in Pearcey is valuable for finite element analysis.
Dr Gunasegaram says in Dell's canned statement that computer simulations are helping the agency's work on nylon mesh for use in pelvic organ prolapse (POP) surgery, something required by one in five women at some point in their lives.
“The computer simulations allow us to better understand the cause-and-effect relationships between mesh parameters, such as pore size and their expected in-vivo performance after implantation, and really focus on the areas with the most influence,” he explained.
The super's name is in honour of Dr Trevor Pearcey, who helped build CSIRO's and Australia's first computer, CSIRAC, in 1949. ®
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CSIRO and Dell supercomputer to mothers’ rescue
Mar 15, 2016 | The Australian
By Chris Griffith
CSIRO is harnessing a supercomputer made by Dell to help combat post-childbirth complications experienced by mothers.
In a partnership forged with Melbourne’s Monash University, CSIRO and Dell have built a high-performance computer cluster to test mesh supports to counter organ movements women can experience years afterwards.
The weakening of abdominal muscles after childbirth can cause body organs to slip, resulting in a prolapse. This can happen weeks, months or sometimes years later, and can be brought on by a bout of coughing, lifting, bending, exercise or seemingly nothing.
Women typically resort to surgery, including mesh implants designed to help keep muscles in place. The research involves inputting hundreds of datasets from researchers involved in prolapse surgery. The Dell supercomputer then simulates the performance of different mesh configurations under various forces — such as when running and jumping. The computational analysis can be done over and over again before testing the mesh on a patient.
Dayalan Gunasegaram, a CSIRO computational modeller behind the project, said improved nylon mesh for use in pelvic organ prolapse surgery could benefit the one-in-five Australian women who have surgery for the condition.
“Current mesh implants that haven’t been well designed for this purpose can lead to pain and discomfort, so we’ve teamed up with researchers from Monash University to develop an improved mesh for supporting prolapsed organs and treating the condition more effectively,” Dr Gunasegaram said.
Dell ANZ managing director Angela Fox said that by collecting information from different sources and patients over many years, a researcher could use the computational ability of this computer to see if there is an easier, alternative way to treat symptoms.
She said Dell was working collaboratively with higher education and research institutions with high-performance computing. For example, there is a collaboration with the University of Sydney on modelling pandemic virus outbreaks globally.
“Markets like Australia tend to lead the way in some of these breakthrough technologies, and adoption of HPC in Australia is 2½ times the global average,” Ms Fox said.
Angus Macoustra, executive manager of scientific computing at CSIRO, said the project was part of CSIRO’s 2020 strategy to be Australia’s innovation catalyst. “It’s about responding to digital disruption and building Australia’s digital capability.”
In this case, it involved accessing datasets of physical observations that happened historically, building a computational model to simulate the forces experienced in the body, to develop solutions around pelvic organ prolapse. “It’s about generating, organising and analysing some significant and massive datasets and delivering valuable as well as trusted insights across many research domains.” The result would be new, suitable nylon mesh implants.
Andrew Underwood, APJ Manager, High-Performance Computing at Dell, said technology was driving a new type of personalised medicine, transforming healthcare by analysing, designing and implementing clinical outcomes.
“Instead of relying on a few experiences, clinicians and researchers can capitalise on the wealth of patient data available in electronic health records and databases, and the data coming off physical models and manufacturing to construct detailed mechanics and statistical models of diseases.
“This massive amount of data can only be analysed by the use of high performance computing.”
Client Attorney Privileged/Attorney Work Product/At Request of Counsel
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