Preview Newsletter
Ethicon Media Monitoring 8/24/2017
-
Inside the Ebaugh v. Ethicon Pelvic Mesh Trial
Aug 23, 2017 | Mesh Medical Device Newsdesk
The trial of Ella Ebaugh got underway earlier this month and the pelvic mesh trial is close to going to the jury. -
What every man needs to know about their prostate and the key to curing those painful urine infections: How to beat health problems when your plumbing goes wrong
Aug 23, 2017 | The Daily Mail
By Jonathan Gornall and Thea Jourdan
... For stress incontinence that persists, and seriously affects quality of life, there are surgical options. Over the past decade or so, women have been given synthetic mesh slings, also known as transvaginal slings or tension-free vaginal tape (TVT), which support internal organs and ‘lift’ the bladder neck and urethra. -
Pontypridd MP ‘hopes to secure vaginal mesh debate’
Aug 23, 2017 | The Glamorgan Gem
The GEM recently ran a story on a Barry woman who had suffered pain after she had received a mesh implant. -
Ethicon, Pennsylvania Transvaginal Mesh Lawsuit Plaintiffs Spar Over Jurisdiction
Aug 23, 2017 | RX Injury Help
By Laurie Villanueva
Ethicon, Inc. is at odds with plaintiffs over the appropriate jurisdiction for 90 transvaginal mesh lawsuits, as the device maker seeks to have the claims removed from a mass tort program now underway in the Philadelphia Court of Common Pleas.Ethicon Targets Pelvic Mesh Lawsuits Filed by Out-of-State Residents -
Dice Run Benefit
Aug 24, 2017 | Ellwood City
In 2000, Melissa “Murf” Becker was given a defective mesh implant in which her body rejected. She has undergone 7 different surgeries to remove the mesh, that her doctors have labeled “chicken wire”, all of the surgeries have failed.
Client Attorney Privileged/Attorney Work Product/At Request of Counsel
Online Sources
-
Inside the Ebaugh v. Ethicon Pelvic Mesh Trial
Aug 23, 2017 | Mesh Medical Device Newsdesk
Mesh Medical Device News Desk, August 23, 2017 ~ The trial of Ella Ebaugh got underway earlier this month and the pelvic mesh trial is close to going to the jury.
Ebaugh, 51, was implanted with two pelvic meshes made by the defendant Ethicon, Johnson & Johnson, the TVT-SECUR and the TVT (tension-free vaginal tape).
The case is the latest and the sixth pelvic mesh product liability mesh case to be heard before jurors in the Philadelphia Court of Common Pleas, which has been a favorable venue to plaintiffs in the past.
Johnson & Johnson has not had a good week.
It began with a record $417 million verdict in the plaintiffs’ favor in a talcum powder-ovarian cancer case in California.
J&J vows to appeal, despite the fact that the plaintiff, Eva Echeverria, is suffering from end stage ovarian cancer.
Now another case is getting close to being wrapped up, this one a pelvic mesh defective product case.
Ebaugh v Ethicon, Case # 130700866 is being held in the same Philadelphia court that has seen five of six juries delivering compensatory damages to the mesh-injured plaintiffs.
Mesh News Desk has transcripts from inside the courtroom and will deliver a series of reports leading up to the verdict, which could come as early as next week.
THE PLAINTIFF
Ms Ella Ebaugh, and her husband, Marvin, live in Pennsylvania. By age 39, she had delivered five children vaginally and was experiencing incontinence.
She had a TVT- Secur sling made by Ethicon (J&J) implanted on May 31, 2007, at Apple Hill Surgical Center in York PA by Paul Douglass, MD. He reasoned since she was so young and had a very active lifestyle, it was the most minimally invasive procedure that would allow her to get back playing sports, like softball, with her children.
Dr. Douglass retired in 2011, but not before he implanted close to one hundred TVT products, according to the defense.
Ms. Ebaugh had to have corrective surgery because of a mid-urethral erosion on July 12, 2007. At that time, she was implanted with another mesh, a TVT.
On June 14, 2011, she had a corrective surgery due to mesh complications. It was done by Howard Mirsky, MD at York Hospital. On March 14, 2102 she had her fourth surgery, and third corrective procedure at the University of Maryland Medical Center with surgeon, Dr. Toby Chai.
Dr. Chai did an ultrascope and thought mesh was in her bladder now. He didn’t find any but removes a few strands of mesh from the urethra. Finally, in 2016, Dr. Wright did surgery to remove more mesh because she was still having complications.
The trail began July 31 in the Philadelphia Court of Common Pleas where there have been four victories and one partial victory for mesh-injured women.
The action alleges design defect and a failure to warn.
Some of the experts we’ve seen in previous pelvic mesh trials will appear here as well – M. Tom Margolis, MD, Dr. Bruce Rozenzweig, MD, Dr. Uwe Klinge, MD, Peggy Pence, Vladimir Iakovlev, Chevron MSDS, and Daniel Elliott, MD.
J&J wanted allegations of spoliation (destruction of documents by J&J) out of the trial and Judge Michael Erdos allowed that.
The judge also ordered that plaintiffs not to introduce evidence that the IFU was defective, however, they may introduce evidence related to the IFU, its risks and warnings in general. The plaintiffs may not introduce evidence of a “David and Goliath” argument, however plaintiffs may introduce evidence of the defendant’s sales figures and profit motive.
Lawyers for the defense include Melissa Merck of Drinker Biddle & Reath LLP, Philadelphia; Kat Gallagher and W. Curt Webb of Beck Redden, Houston, TX.; Phillip Combs and Daniel Higginbotham of Thomas Combs and Spann, Charleston WV; Julie Callsen of Tucker Ellis, Cleveland; Jordan Walker of Butler Snow.
Lawyers for Ms. Ebaugh include Lee Balefsky, Kila Baldwin, who delivered the opening to jurors, Christopher Gomez and Tracie Palmer of Kline & Specter, Philadelphia.
The jury is made up of all African Americans, six female and six males, mostly middle-aged.
Plaintiffs’ Open
On August 4, Ms. Ebaugh’s attorney Kila Baldwin delivered her opening statement to the 12 jurors.
Judge Erdos reminded the jurors that the plaintiffs have the burden of proof based on the credibility, truthfulness, accuracy and weight of the testimony and other evidence. The jurors were instructed not to talk about the case, even to each other and even in a casual setting, and not to do any independent research, including on the Internet. Jurors are allowed to take notes during the proceedings, but not the opening or closing statements, however they cannot take the notes outside of the courtroom.
Friday afternoon, Ms. Baldwin reminded the jurors the TVT-Secur was sold only from 2006 until 2012 when it was removed from the market. The TVT is still sold.
“These defective products have literally mangled Ella Ebaugh’s urethra,” said Ms. Baldwin. Pain, incontinence will cause her to suffer with this for the rest of her life.
Ethicon is a company forth $70,418,000, said Baldwin, while Ethicon is worth $2,762,000, she said. This defendant makes decisions with money in mind. She showed a logo from “Ethicon’s Women’s Health and Urology. Show me the money,” it says. That was given to the marketing department in 2007.
“This is what Ethicon was concerned about when it marketed its TVT line of products, which includes the two that are at issue in this case.”
In the case of TVT-S they never tested it in humans in a robust study before the y put it on the market. In the case of TVT, they paid for the results and never verified the underlying data.
“Ella Ebaugh is a casualty of the reckless conduct.”
Ethicon produced a different mesh with larger pores that didn’t causing scar plate formation. Ultrapro is made of half polypropylene and half Monocryl, absorbable mesh. Its larger pore size avoids scar plate formation and bridging fibrosis, a larger solid scar plate that causes mesh to shrink. Ethicon has another mesh with medium sized pores, Dynamesh, which was also never used in the TVT line of products.
Scar plate formation is the first indication the mesh is defective, chronic inflammation is the second defect, said Baldwin. Inflammation is in reaction to a foreign body, in this case the Prolene plastic that is not inert. The reaction does not fade over time. This chronic foreign body response is also known as giant cell reaction which comes with more mesh in the body as compared to a tiny suture.
Erosion, mesh migration are also indication the mesh is defective. Ebaugh had three erosions with five perforations to her urethra. The jurors are shown blue inside her urethra along with calcium deposits.
The TVT-S also has felt tips to hold it in place. They aren’t working, said Baldwin. The mesh migrates around the body and can easily get out of place increasing the risk of erosion. TVT-S is a laser cut mesh, which is three time as rigid as mechanical cut mesh, making it more likely to erode.
Before mesh there was a Burch procedure, using stitches to hold up the vagina and support the urethra. There is another surgical option, the MMK procedure using animal tissues a porcine graft or a cadaver tissue or tissues from your own body to provide a sling support. If they don’t work there are almost no long-term problems, she said.
TVT, TVT-S
TVT was launched after Ethicon bought the device for $24 million to Ulf Ulmsten, whose name has been mentioned in many product liability mesh trials. That was 1996. By 2004 the TVT was worth $100 million to the company, or 91% profit. It was a good investment, Baldwin said.
TVT-S was developed by Dan Smith an Ethicon engineer, in order for Ethicon not to lose market share with its competitors.
It couldn’t be tested before marketing because of budget constraints. What was done on the TVT-S was five weeks of randomized control trial on 31 women. The results were never published, Baldwin says thirty percent of the women it failed within five weeks. Ethicon launched the product anyway.
An executive at Ethicon in Germany said “The more procedures, the more problems” referring to TVT-S. The TVT-S validation studies are referred to as a big steaming pile of dot, dot dot, say internal Ethicon documents. Another says TVT-S is “pretty awful.”
“How can we spin it?” referring to the data…”How can we jazz it up?” says another exhibit.
TVT-S was pulled from the market in Australia in 2006 by the Ethicon medical director, Aran Maree, but it continued to be sold in the U.S. Key opinion leader Dr. Vincent Lucente, who was paid more than $2 million by Ethicon, had a horrible failure rate, 60% with TVT-S, but that data was never published, the jurors were told.
When the TVT-S didn’t work, put in another mesh right on top, recommended the company.
Dr. Douglass, who implanted Ms. Ebaugh, is quoted as saying, ‘Yeah, I like the TVT, I like to do it in outpatient centers because that way I could put more products in in one day.”
Ethicon/ Johnson & Johnson had an $800 million prelaunch marketing budget for the TVT-S, some of that money going to pay key opinion leaders such as Lucente, and to sponsor industry events such as AUGS, the American Urogynecologic Society, the Society of Urodynamics, Female Pelvic Medicine, and Urogenital Reconstruction.
Ebaugh today has a mangled urethra, covered in scar tissue near the opening and middle. She has almost no control and has been diagnosed with Intrinsic Sphincter Deficiency, which includes uncontrolled spasms of the bladder.
She cannot get a good night’s sleep because she has to urinate during the night. She’s a prisoner of her house now.
“What she wants is a normal life.” ###
https://www.meshmedicaldevicenewsdesk.com/inside-ebaugh-v-ethicon-pelvic-mesh-trial/
-
Aug 23, 2017 | The Daily Mail
By Jonathan Gornall and Thea Jourdan
· Problems with our personal plumbing are incredibly common for many people
· In the final part of our series we look at what can go wrong with your waterworks
Problems with our personal plumbing are incredibly common — from cystitis to incontinence after childbirth, or prostate troubles.
In the final part of our series we look at what can go wrong with your waterworks — and what can be done to help...
Although rarely talked about, urinary incontinence affects millions of people in the UK.
And it seems many are too embarrassed even to talk to their doctor about it — one survey found that 60 per cent of women with incontinence problems would not go to their GP for help.
But just putting up with it means you miss out on treatment that can improve the situation. There are various types of incontinence, which have different causes and therefore require different solutions. But the key thing is you don’t have to live with it.
Stress that’s no laughing matter
Small leakages of urine when you cough or laugh is known as stress incontinence. It happens when the bladder neck cannot remain closed under physical stress.
‘In women, this can happen after childbirth, when the neck gets stretched during delivery, or because the pelvic floor muscles are weakened, causing the neck to sag,’ says Mike Bowen, a consultant gynaecologist based at the Nuffield Health Oxford Hospital.
In men, removal of the prostate gland (prostatectomy) ‘is the principal cause for stress urinary leakage’, says Giles Hellawell, a consultant urological surgeon at The London Clinic, and at Imperial College Healthcare NHS Trust. This may only be temporary — though men may have to wear pads while it settles down.
To diagnose stress incontinence, a GP can perform a bladder stress test, which is usually done lying down: fluid is inserted into the bladder using a thin tube — you’ll be asked to cough and the doctor will check for fluid loss. The test may be repeated standing up.
There is also a pad test when you will wear an absorbent pad for a period of time. It will be weighed afterwards to work out how much urine you have lost without going to the loo.
Pelvic floor exercises are very effective at helping to alleviate stress incontinence. A review of studies published in 2010 found up to a 70 per cent improvement in symptoms of stress incontinence in women after appropriately performed exercises (see overleaf for how to do these, as well as gadgets that can help).
For stress incontinence that persists, and seriously affects quality of life, there are surgical options. Over the past decade or so, women have been given synthetic mesh slings, also known as transvaginal slings or tension-free vaginal tape (TVT), which support internal organs and ‘lift’ the bladder neck and urethra.
However, recently there have been concerns about the material in these shredding and cutting into the bladder and nearby tissue. More than 92,000 women had vaginal mesh implants from 2007 to 2015 in England, and a 2012 Government report found that around 15 per cent experienced complications.
Campaigners, including doctors and women who have been affected, are calling for a return to older sling techniques, including the open Burch colposuspension, which used the woman’s own tissues to recreate a stable pelvic floor.
There is a newer sling procedure known as a trans-obturator tape (or TOT) — available on the NHS and privately — which supports the urethra using a tension-free tape slung between the two obturator foramens (holes in the pubis bones of the pelvis which allow passage of nerves and blood vessels). Unlike the TVT operation, the tape does not go close to the bladder to keep it in its correct position.
‘Trans-obturator sling procedures have a success rate of 85 per cent,’ says Mr Bowen. ‘Research has shown it is much less likely to lead to bladder damage.’
Men with stress incontinence after prostate surgery, which hasn’t improved after 18 months, can also opt for a sling procedure, where a synthetic mesh is positioned to give the urethra support.
There isn’t any long-term data for this relatively new operation, but so far about 80 per cent of men are able to stop using pads afterwards or their urinary leakage is halved.
When you can't hold on
If you feel a near-constant need to urinate, or feel as though you can’t ‘hold on’ when you do need to go, this is likely to be urge incontinence. This differs from stress incontinence, when the pelvic floor muscles are too weak to prevent urination.
Urge incontinence is twice as common among women as men and is caused by damage to nerves in the bladder or muscle, bladder stones, infection or bladder inflammation. But in most cases, no cause can be found.
Leakage occurs because the bladder muscles squeeze or contract at the wrong times, not just when your bladder is full.
Overactive bladder, when the bladder muscles contract too often, is one cause of urge incontinence. It creates an uncomfortable feeling of wanting to urinate all the time. Some men suffer overactive bladder and flow problems because of an enlarging prostate, which can block the urethra — the tube which carries urine from the body. ‘The bladder is having to increase the pressure to maintain flow. Eventually, it becomes unstable, leading to overactivity,’ says Mr Hellawell.
It can be diagnosed through urodyanamic testing, which includes noting if someone can stop urine flow mid-stream, or using sensors to check pressure within the bladder and measuring nerve activity. This can evaluate how well the bladder, sphincters and urethra are storing and releasing urine.
Unlike with stress incontinence, there are drug treatments for urge incontinence and an overactive bladder. It can be stabilised with anticholinergic drugs, which work by dulling the autonomic, or involuntary, nervous system which controls the functioning of organs such as the bladder, heart, lungs and genitals.
‘But the side-effects of these medications are not great,’ says Mr Hellawell. ‘Not only will they lessen the bladder contractions, they will also lessen bowel contractions, leading to constipation.’ Anticholinergic drugs will also affect the lacrimal glands behind the eyes and the salivary glands, leaving patients complaining of dry eyes and dry mouth. They take 12 weeks to take full effect — and while the idea is to take the drugs for life, patients are unlikely to want to take them long term.
But there’s a new prescription drug available called mirabegron, marketed as Betmiga, which works by relaxing muscles in the bladder.
Injecting Botox into the bladder muscle has been found to be effective because it paralyses the muscles for up to two months. It is available in a few centres on the NHS, but it is not currently licensed to treat urge incontinence so doctors need to go through all the risks before a patient can decide to go ahead.
Constant trickle linked to prostate
Overflow incontinence is caused when the bladder never fully empties and small amounts dribble out all the time, rather than only when the bladder is under stress. People with this type of incontinence may not always sense that their bladder is full.
It is more common in older men and is often due to an enlarged prostate. Women can suffer from this type of incontinence too, when the urethra is blocked by prolapsed organs or kidney stones. It is often diagnosed when someone has frequent bladder infections caused by a back-up of urine, which grows bacteria.
To diagnose it, you may be asked to go to the loo and completely empty your bladder before a doctor inserts a catheter to see if more urine comes out — if more urine is produced it could indicate overflow incontinence.Men with an enlarged prostate may be helped by drugs called alpha adrenergic agonists, such as clonidine, which reduce contractions of the bladder and the urge to pass water.
Medicines, such as the ‘alpha blockers’ tamsulosin and alfuzosin, can also be prescribed to relax the muscle in the prostate, taking the pressure off the urethra. Many herbal and other alternative treatments can be found online, but there is no evidence to show any is effective at countering an enlarged prostate.
Leakages can be controlled by absorbent pads or men can use a urinary sheath, worn like a condom with a tube leading to a bag.
For treatments for overflow incontinence in women caused by prolapse, see panel, right.
When going to the loo at night is a problem
For both men and women over 50, getting up to pee once a night is normal, and twice a night over 65. In men, an enlarged prostate or (more rarely) prostate cancer can be a cause. But because it happens to men and women, all the blame for ‘nocturia’ — needing to go at night — can’t be laid on the prostate: disturbed sleep patterns and medications including blood pressure drugs can all play a part.
It is, says Mr Hellawell, important to check that the issue isn’t an undiscovered cardiac problem, which can cause fluid retention.
Lifestyle can play a part. ‘I have patients who have a couple of strong coffees or teas last thing.’ Caffeine encourages urination, and ‘is also known to cause bladder instability’ — triggering a need for frequent or urgent weeing.
How to cure those painful urine infections for good
Cystitis, or inflammation of the bladder, is one of the most common types of urinary tract infection (UTI) and affects more than 90 per cent of women.
It is typically caused by bacteria invading the bladder wall, explains Con Kelleher, an obstetrician and gynaecologist based at Guy’s and St Thomas’ NHS Foundation Trust. Pain when urinating or passing frequent, small amounts of urine are signs of cystitis. So, too, is blood in the urine, which can make it pink and cloudy — but it can indicate other problems such as bladder cancer, too, so always talk to your GP.
It’s far more common among women than men. ‘The anus is closer to the urethra [the tract that carries urine from the bladder out of the body] in women and the urethra is shorter,’ explains Mr Kelleher. ‘This makes it more likely that bacteria will invade.’
‘UTIs should not be ignored since they can lead to more serious complications such as kidney infection as the bacteria travel up from the bladder,’ says Emma Soos, a nurse with a special interest in urology and director of the Women’s Health Clinic.
For mild cystitis, drinking plenty of water can help flush out bacteria. Although many people believe that cranberry juice can help, recent research found no evidence that the fruit, taken as capsules, made any difference to bacteria in urine.
The antibiotic trimethoprim (Monotrim) is the main treatment and works in 80 per cent of infections. Adults with UTIs which are not responding to treatment should have their urine tested to identify the bacteria causing the problem so they can be targeted with the most effective drugs.
Professor James Malone-Lee, based at University College Hospital, advocates, for some patients, high-dose, long-term treatment with highly-targeted antibiotics, combined with an antiseptic medication called Hiprex, prescribed by a specialist.
To prevent UTIs, wearing clean cotton underwear, avoiding perfumed products and wet wipes, which can be irritating, and wiping front-to-back are effective. Always passing urine at bedtime and after sex —during which bacteria can transfer to the urethra — can also help.
‘MALE CYSTITIS’
Although men can get cystitis, more common is prostatitis — inflammation of the prostate gland which affects half of men and is sometimes called ‘male cystitis’.
Symptoms include pain when urinating, frequent urination and the urgent need to pass water, cloudiness or blood in the urine and pain in the abdomen, groin or lower back. Sometimes it causes sexual problems such as low libido and erectile dysfunction.
Prostatitis is diagnosed by ruling out other conditions that could be causing symptoms, such as cancer. A doctor may give you a physical examination, order urine and blood tests and sometimes a scan of your urinary tract and prostate to check for underlying issues.
In about 10 per cent of cases it can be down to bacterial infection. ‘This type comes on quickly and can cause a high fever, chills, muscle aches and joint pain, as well as pain in the perineum and around the base of the penis and difficulty passing urine,’ says Professor Roger Kirby, from the Prostate Centre.
Treatment is with antibiotics. ‘In severe cases, a man may need antibiotics for four to six weeks, or even longer,’ says Professor Kirby.
Professor Christopher Eden, a urological surgeon at Royal Surrey County Hospital, says the quinolone class of antibiotics are most effective at entering the prostate gland.
‘You often find that GPs prescribe the wrong sort, such as trimethoprim, penicillins and nitrofurantoin which won’t have much effect,’ he says.
The most common type of prostatitis is not caused by bacteria at all. Chronic prostatitis without bacterial infection, also known as chronic pelvic pain syndrome (CPPS) is diagnosed when men complain of pain around their back passage and discomfort passing urine — yet tests reveal no bugs in the urine.
‘Most experts believe this is caused by scar tissue left after a bacterial infection has resolved — this can stimulate nerves which continue to send signals to the brain that there is inflammation,’ says Professor Eden.
New evidence suggests it may be down to chronic spasms in the pelvic floor. Treatment for CPPS includes alpha blockers, which can help by relaxing the bladder neck and the muscle fibres within the prostate.
Some patients seem to benefit from Cialis, used to treat erectile dysfunction, in doses of 5 mg per day which can also improve sexual function. Botox injections into the prostate have been used to reduce muscle spasms. And physical therapy to relax the pelvic floor muscles has been shown to help.
Frequent sex and masturbation are sometimes cited as ways to reduce the pain of prostatitis, but Professor Eden says that this is probably a myth. ‘But some men do say that it helps.’
‘For some men, surgical removal of the prostate is worth considering as a last resort,’ adds Professor Eden.
Prolapse: What really does work?
The worst cases of prolapse can make women feel as if their insides are literally falling out.
But some are too minor even to cause symptoms and are discovered during an examination for something else.
‘The ligaments and muscles that make up the pelvic floor start to stretch, and the organs in the abdomen slip down,’ says Dr Philip Owen, a consultant obstetrician and gynaecologist at the Princess Royal Maternity Hospital in Glasgow.
Stretching can occur during pregnancy and childbirth. Being overweight and ageing are risk factors. According to the Royal College of Obstetricians and Gynaecologists, half of women over 50 will have some degree of prolapse.
‘Menopausal women are at risk as muscle tone deteriorates and oestrogen levels fall, which cause the wall of the vagina to become thin and less able to support itself,’ says Dr Owen.
TYPES OF PROLAPSE
Utero-vaginal: The uterus protrudes into the vagina and in some cases slips out. Up to 30 per cent of women who have had children develop a utero-vaginal prolapse later in life. They are common in postmenopausal and overweight women as the weight puts pressure on the abdomen.
Bladder: The bladder pushes into the vagina and ‘this can create a “reservoir” of urine that cannot be emptied which can lead to irritation, spasms and incontinence,’ says Dr Owen. It can also result in leaking when a woman laughs or coughs.
Rectocele: This occurs when a loop of the bowel presses into the vagina, creating an S-bend where faeces can collect. ‘In some cases, women find it difficult to empty their bowels,’ explains Dr Owen.
Rectocele mostly occurs in women who have undergone a hysterectomy.
TREATMENTS
Losing weight can help to lessen the pressure on the abdominal area. Physiotherapy can reduce the symptoms of any pelvic organ prolapse. Your doctor can refer you.
Ring-shaped pessaries can add support within the vagina. They are worn all the time and need to be replaced every six months.
Surgery may be offered for severe uterine prolapse. One option is synthetic mesh to support the pelvic floor, but this has been linked to long term side-effects. Other options include autologous slings, created from a woman’s tissue.
See your doctor if you have chronic constipation, as long term straining contributes to prolapse.
Prostates: What every man needs to know
When it comes to men’s ‘plumbing’ issues, the culprit in many cases is the prostate, the gland which produces the fluid that mixes with sperm to create semen.
In a piece of inarguably poor design, the walnut-sized prostate, which is positioned below the bladder, is wrapped around the urethra, the tube that carries urine out of the body through the penis.
That arrangement works just fine when men are in their prime. But as men grow older, the prostate gradually enlarges, placing increasing pressure on the urethra and interfering with the flow of urine.
That, says consultant urological surgeon Giles Hellawell, is when alarm bells start ringing for most men.
‘Of course, prostate cancer is the first thing that goes through their minds,’ he says — difficulty urinating, or needing to urinate more often are common symptoms of prostate cancer. ‘But the first thing I say to patients referred to me is that about half of men over the age of 50 have some degree of prostatic enlargement — a benign condition — and quite a high proportion of those will have some reduction in flow.’
In fact, most men who go to see their GP have been spooked by symptoms caused by a harmlessly enlarged prostate. They might have poor flow of urine — what once was a river in flood becomes a mere stream. Or, if they have tolerated poor flow for a number of years, as many men do, they may have started to experience secondary effects on the bladder.
These effects can include ‘urinary frequency’ — having to go to the loo a lot — or ‘urgency’, a sudden, overwhelming urge to go. But for many, says Mr Hellawell, the trigger to go and visit the GP is having regularly to get up once or twice during the night to pass water.
A GP confronted with a man worried about urinary problems will usually conduct a physical examination of the prostate to see if it is, indeed, enlarged. If it is, the next step will be a blood test to check for levels of a protein called Prostate Specific Antigen, or PSA. This is produced by cancerous cells in the prostate, but also by normal ones, and PSA levels rise naturally as men grow older.
A S A result, a raised PSA level is just an indication that further tests might be necessary, says Mr Hellawell. The PSA throws up ‘false positives’ and many men with an elevated reading do not have prostate cancer.
Conversely, though less often, some men with a low PSA reading do prove to have the condition. So ‘increasingly we don’t rely just on that’, he says.
‘In my NHS practice we always do an MRI scan of the prostate once the patient has come in with elevated PSA before deciding whether to do a biopsy.’
Prostate cancer ‘affects more than 300,000 men in the UK and kills one man every 45 minutes’, says Ali Rooke, senior specialist nurse at Prostate Cancer UK. ‘However, it’s a disease which can be successfully treated, if caught early enough.
In many cases, prostate cancer doesn’t have any symptoms at all, especially in its early stages. ‘Therefore, being aware of your risk is crucial and is a man’s best line of defence,’ she says. Men over 50, black men, or men with a father or brother who has had the disease all face a higher than average risk.
‘If you fall into one of these high-risk groups, or have noticed any changes in your waterworks, it’s important to have a conversation with your GP about your risk.’
Anyone with concerns about prostate cancer can contact Prostate Cancer UK’s specialist nurses on 0800 074 83 83.
If cancer has been ruled out, a benign enlarged prostate can be treated. This can mean lifestyle changes — cutting down on caffeine, which irritates the bladder, and alcohol, generally drinking less in the evening — and learning to ‘double void’: peeing, waiting a few seconds, and peeing again.
Some men with enlarged prostate develop overflow incontinence — where they leak urine (See previous pages) .
In cases of ‘chronic urine retention’, in which peeing is really difficult, a man may have to regularly insert a catheter through the penis to drain the bladder.
When cancer is found, or in some cases of a severely enlarged but benign prostate, a prostatectomy, in which part or all of the prostate is removed, will be carried out. This can lead to other problems.
The problem is that the prostate ‘is not a greatly located organ: it’s very close to the bladder and the voluntary sphincter, which allows you to relax and have a wee. If one is going to surgically remove it you have to be careful,’ says Mr Hellawell.
Even then, following a standard prostatectomy the risk of incontinence is about 5 per cent or higher. Sometimes this is only temporary. ‘We usually wait 12 to 18 months after the operation to see what the eventual baseline incontinence levels will be, and luckily in the majority of patients it does improve,’ explains Mr Hellawell. During this time men may have to wear pads.
If there is no improvement, more surgery can be carried out. This includes the insertion of an internal urethral sling, a synthetic mesh positioned to give the urethra some support.
Still a relatively new innovation, used in men and women, there are no long-term results for this operation, which usually involves two nights in hospital. But in the short-term there is a success rate of about 80 per cent — with success defined as being able to stop using pads or seeing urinary leakage reduced by half.
For severe cases of incontinence an artificial urinary sphincter can be fitted to replace the weakened ring of muscle that contracts to prevent urine leaving the bladder. The artificial device, which is filled with fluid to compress the urethra, is operated by a small hand pump concealed in the scrotum.
Patients aged 70 or older are more likely to be given radiotherapy to reduce the size of an enlarged prostate rather than undergo radical surgery. There is little evidence to show one procedure is better than the other, but with older patients there is more caution about giving anaesthetics and undergoing a lengthy operation.
WHEN YOU FIND A LUMP...
Understandably, many men become worried when they find a lump in their scrotum — but only four in 100 is likely to be cancerous. Frequently what they have found is a harmless testicular cyst, says Giles Hellawell.
By the age of 50, between 15 and 20 per cent of men can expect to have a testicular cyst of some kind, a lump they can feel at the top of one of their testicles.
Cysts are situated in the epididymis, a duct that carries sperm from the testes, and which is often tender in its own right. ‘Typically, somebody has a slightly tender epididymis, which can happen from a bit of inflammation, and they examine it and find a lump,’ says Mr Hellawell. ‘But it’s not actually in the testes, it’s in the bit above.’
A cyst is best left alone, says Mr Hellawell. It rarely causes pain or discomfort and removing it is not without possible consequences: ‘The testes area is not a great place to operate on because the risk of infection is so high.’
To reassure a man his lump is harmless, ‘we would almost automatically get an ultrasound scan, certainly up to the age of 40 and probably beyond.’ This can also pick up hernias and hydrocele testis, a build-up of fluid around the testes. ‘Men should get to know how they usually look and feel, which can help you spot if something changes,’ says Fiona Osgun, Cancer Research UK’s senior health information officer.
Any lump, swelling, change in firmness or texture of the testicles, or a feeling of heaviness or pain in the testicles or scrotum should be checked out by a doctor.
http://www.dailymail.co.uk/health/article-4818148/How-beat-health-problems-plumbing-goes-wrong.html
-
Pontypridd MP ‘hopes to secure vaginal mesh debate’
Aug 23, 2017 | The Glamorgan Gem
The GEM recently ran a story on a Barry woman who had suffered pain after she had received a mesh implant.
Pauline Inch had attended a Parliamentary meeting at Westminster on July 18 hosted by Owen Smith, the MP for Pontypridd which was addressed by gynaecologists, urologists, and ‘Sling the Mesh’ campaigner Kath Sansom.
Following the meeting, Mrs Inch was able to pass on contact details to another Vale woman who was concerned by symptoms she was experiencing.
Owen Smith’s office has told The GEM that he hopes to have a Westminster Hall debate on ‘mesh’ in September.
He had previously applied for one in June, but was unsuccessful in the ballot.
http://www.glamorgan-gem.co.uk/article.cfm?id=115386&headline=Pontypridd%20MP%20%E2%80%98hopes%20to%20secure%20vaginal%20mesh%20debate%E2%80%99§ionIs=news&searchyear=2017
-
Ethicon, Pennsylvania Transvaginal Mesh Lawsuit Plaintiffs Spar Over Jurisdiction
Aug 23, 2017 | RX Injury Help
By Laurie Villanueva
Laurie Villanueva is an attorney with Bernstein Liebhard LLP
Ethicon, Inc. is at odds with plaintiffs over the appropriate jurisdiction for 90 transvaginal mesh lawsuits, as the device maker seeks to have the claims removed from a mass tort program now underway in the Philadelphia Court of Common Pleas.Ethicon Targets Pelvic Mesh Lawsuits Filed by Out-of-State Residents
Ethicon, a subsidiary of Johnson & Johnson, is named a defendant in 120 pelvic mesh lawsuits that are currently pending in Philadelphia. According to The Legal Intelligencer, the 90 claims at issue were filed on behalf of non-Pennsylvania residents.
In seeking to have the transvaginal mesh lawsuits removed from Philadelphia, Ethicon cited the U.S. Supreme Court’s recent decision in Bristol-Myers Squibb v. Superior Court of California, which limited plaintiffs to filing suit in jurisdictions where defendants are headquartered or where a plaintiffs’ injuries are alleged to have occurred.
While Ethicon is based out-of-state, the Prolene filaments used in its transvaginal mesh devices were manufactured and supplied by Secant, which is headquartered in Pennsylvania. However, in a brief filed with the court on August 21st, Ethicon maintained that it only had a limited contractual relationship with the company.
“Plaintiffs have not shown and cannot show Secant was anything other than an independent biomaterials supplier,” Ethicon said. “The record reflects only what any contracting party would seek and expect: the delivery of what it has agreed to pay for and the means to assure the other side’s compliance. Merely contracting to have mesh knitted from filament by an independent company does not confer jurisdiction.”
However, attorneys representing transvaginal mesh plaintiffs rejected Ethicon’s arguments, writing in their own brief that the trial court had already addressed the jurisdictional issues when the mass tort was established. They also contend that Ethicon had a close relationship with Secant, often meeting at the company’s Pennsylvania headquarters. Finally, the brief notes that Ethicon also worked closely with a Pennsylvania gynecologist to develop its pelvic mesh devices.
“Through those contracts, Ethicon chose Pennsylvania as the location where Ethicon directed the design, manufacturing, testing and overall production process for Prolift mesh,” the plaintiffs’ brief states. “Ethicon chose Pennsylvania as the place where it funded extensive clinical studies and paid for the services of a prominent Pennsylvania consultant.”Transvaginal Mesh Injuries & Complications
Transvaginal mesh devices are intended to treat women suffering from pelvic organ prolapse and stress urinary incontinence. Since 2008, the U.S. Food & Drug Administration (FDA) has issued several warnings regarding serious complications potentially associated with transvaginal mesh, including mesh erosion, scarring and adhesions, chronic pain, infections, and organ damage. The agency has also reclassified transvaginal mesh used for prolapse repair as a high-risk medical device, after reversing its stance that complications associated with its use are rare.
The Pennsylvania litigation has already concluded five trials involving Ethicon transvaginal mesh lawsuits. Four juries have favored plaintiffs, awarding them damages of $2.16 million, $12.5 million, $13.5 million and $20 million. While one jury did rule in favor of Ethicon, the judge overseeing the case recently granted the plaintiff a new damages hearing after finding that the verdict was inconsistent with the evidence.
More than 54,000 women are currently pursuing pelvic mesh lawsuits against Johnson & Johnson and Ethicon in courts nationwide. Tens of thousands of additional cases have been filed against Boston Scientific Corp., C.R. Bard, Inc., and other device makers.
In 2012, Ethicon announced that it would stop selling several transvaginal mesh implants due to slowing sales and other commercial concerns. However, the FDA had previously ordered Ethicon and other vaginal mesh manufacturers to conduct further research into the risks associated with their products.
http://www.rxinjuryhelp.com/news/2017/08/23/ethicon-pennsylvania-transvaginal-mesh-lawsuit-plaintiffs-spar-over-jurisdiction/
-
Aug 24, 2017 | Ellwood City
In 2000, Melissa “Murf” Becker was given a defective mesh implant in which her body rejected. She has undergone 7 different surgeries to remove the mesh, that her doctors have labeled “chicken wire”, all of the surgeries have failed.
She has developed multiple problems, she suffers from Celiac’s Disease, pelvic pain, chronic long term pain and neuropathy.
Melissa is now confined to a wheel chair because the simple act of walking is extremely painful. She has seen many doctors who refuse to operate due to the complexity of the mesh implant in her body.
After extensive research she found a top doctor in Tennessee who is willing to perform surgery. However, insurance companies will not cover expenses and it’s been to long to take the makers of this “chicken wire” to court.
The benefit will help to lessen the costs that Melissa will incur for her surgery and stay.
A Dice Run is being hosted for the benefit of Melissa on Saturday, September 30.
The ride will start and end at the Ellwood City Saxon Club and registration will be from 10:30—11:30, bikes pull out at 12:00.
Stops will include the Beacon Hotel, Longhorn, and the Burgh Bar. The cost is $15/bike $25/with passenger.
Dinner and entertainment by The Amaretta Band is included with the price of the tickets
If you’re not riding but would still like to participate, you can join for dinner and entertainment for $10 person.
Donations are welcomed and appreciated, to donate or for more information please contact Laura Gruber at 724-333-0547 or Kelly McClean, 724-355-6101.
http://ellwoodcity.org/2017/08/23/dice-run-benefit/
Client Attorney Privileged/Attorney Work Product/At Request of Counsel
Online Sources
Add recipients
Suggested