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Ethicon 10/13
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More seeking help for incontinence
Oct 13, 2015 | Straits Times (Singapore)
By Ng Wan Ching
...Urinary incontinence is the involuntary leakage of urine, said Dr Tricia Kuo, a consultant with the department of urology at Singapore General Hospital (SGH)... -
Boston Scientific Denied New Trial in $100 Million Barba Case
Oct 12, 2015 | Mesh Medical Device News Desk
By Jane Akre
It was last May when the highest jury award in mesh litigation was issued so far – $100 million to Deborah Barba and her husband.
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More seeking help for incontinence
Oct 13, 2015 | Straits Times (Singapore)
By Ng Wan Ching
The first time she tried to do a jump after her second child was born three years ago, she wet herself.
The 35-year-old mother of two was following an exercise video, about seven months after having given birth.
Surprised, but not alarmed, at what had happened, she went to the bathroom to clean up and pass more urine.
She then went back to the exercise and promptly wet herself again. That was when she realised something was wrong.
But worse was to come.
Months later, when the designer, who wants to be known only as Madam TC, started eating apples in the morning, she found herself rushing to the toilet to pass motion.
She is among a growing number of people here seeking help for urinary and faecal incontinence.
Urinary incontinence is the involuntary leakage of urine, said Dr Tricia Kuo, a consultant with the department of urology at Singapore General Hospital (SGH).
Faecal incontinence is the inability to control bowel movements, which results in faeces leaking unexpectedly from the rectum, said Dr Cherylin Fu, a consultant at SGH's colorectal surgery department. It can range from an occasional leakage of stools while passing gas to a complete loss of bowel control.
The number of incontinent patients who have been seen by SGH's pelvic floor disorders service has more than doubled since it was started in 2008.
From an initial 30 to 40 patients a year, the number has risen to over 100 so far this year, said Dr Fu.
Reasons for the increase include:A greater awareness of such disorders and available treatments.Less stigma. Also, patients are more willing to discuss their conditions with their doctors.More elderly patients seeking treatment in order to maintain an active lifestyle.
Incontinence becomes more prevalent as one ages, said Dr Fu.
For most women, incontinence starts later, usually after menopause. However, the damage to their pelvic floor would have occurred much earlier.
This is the result of pregnancy and childbirth, said Dr Fu.
They might not have noticed it when they were younger because their pelvic floor and sphincter muscles were still strong enough to compensate for the deficiencies.
As women age and their pelvic floor weakens because of hormonal changes and gravity, symptoms appear, said Dr Fu.
Some women below the age of 45, like Madam TC, could experience incontinence much earlier, said Dr Fu, perhaps because they suffered more damage from childbirth after a difficult delivery.
Sphincter tears might also have occurred during delivery, she said.
But those who have never given birth and men can be affected too.
Pelvic floor disorders vary - they include incontinence due to pelvic floor weakness, as well as difficulty in passing urine and stools due to tight pelvic muscles.
Some patients might strain themselves habitually while passing motion or lift heavy loads constantly, which could cause the pelvic floor to prolapse.
Yet other patients could have connective tissue disorders that predispose them to weakening of the pelvic floor ligaments and muscles, said Dr Fu.
The longer a pelvic floor disorder is left unattended, the more severe the symptoms are likely to be, she stressed.
The good news is that most conditions can be addressed even after they have become longstanding.
The management of each case would involve discussions between the medical specialities involved - colorectal surgery, urology and gynaecology - to work out the best course of treatment, said Dr Fu.
For example, a patient who has symptoms of urinary and faecal incontinence due to pelvic organ prolapse could go for medical therapy first.
This could include dietary adjustments, avoiding of triggers that might result in loose stools, medications such as anti-diarrhoea pills and biofeedback therapy, said Dr Mark Wong, director of the SGH pelvic floor disorders service.
Biofeedback therapy involves a series of exercises such as squeezing, holding and relaxing of the anal muscles, which are coordinated with one's breathing and abdominal contractions, said the consultant at the colorectal surgery department.
Such therapy could be followed by surgery to correct pelvic organ prolapse and further treatment for faecal incontinence.
For Madam TC, surgery is not yet an option. She tried Kegel exercises, in which the pelvic floor muscles are tightened and released repeatedly, and physiotherapy. They did not work well.
In June, she saw Dr Fu, who recommended biofeedback therapy to train her pelvic floor muscles to work properly again.
After three sessions, she feels she can control her bowels better.
"If I feel the urge during breakfast, I can finish my meal before walking to the toilet to relieve myself. Previously, I had to drop everything and run to the toilet," she said
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Boston Scientific Denied New Trial in $100 Million Barba Case
Oct 12, 2015 | Mesh Medical Device News Desk
By Jane Akre
It was last May when the highest jury award in mesh litigation was issued so far – $100 million to Deborah Barba and her husband.
Ms. Barba had been implanted with Boston Scientific’s Pinnacle Pelvic Floor Repair Kit as well as an Advantage Fit mid-urethral sling system.
See the Mesh New Desk story on the verdict here.
On October 9, Judge Mary M. Johnston was asked to grant a Defense motion for a new trial and to set aside the jury decision.
The requests were denied.
What Judge Johnston did grant was a reduction in the $75 million in punitive damages saying the amount “shocked the court’s conscience and sense of justice.”
It was reduced to $7.5 million, reached by tripling the average punitive award of $2.5 million. The entire decision amounts to $32.5 million. Boston Scientific has appealed.
See the jury questionnaire form here.
See the Judge’s decision here.
Judge Johnstone said the Delaware jury was attentive and diligent during the two-week trial which featured the testimony of 15 experts.
BACKGROUND
The 51-year-old from Newark, Delaware, Ms. Barba sued manufacturer Boston Scientific for her permanent and serious injuries caused by the company’s Advantage Fit and Pinnacle transvaginal meshes. She was implanted in 2009 and has suffered significant complications and endured two surgeries that did not fully remove the devices.
The jury found Boston Scientific was negligent in its design and manufacture of the Pinnacle and Advantage Fit devices and that the warnings were insufficient to unsuspecting doctors and their patients.
The Advantage Fit remains on the market. Pinnacle was voluntarily recalled May 2011, three years after it was launched, after a growing body of adverse events or complications were coming in.
That voluntary recall is not something the jury is not allowed to hear in this case as both sides have agreed to motions to limit the scope of the trial. See background story, The Problem with Polypropylene.
In asking for a new trial, Boston Scientific claimed a “failure to warn” claim is barred by the learned intermediary defense. In other words, it is the doctor whose job it is to warned a patient since he or she is the “learned intermediary.”
Boston Scientific also claimed there was no evidence presented at trial that the company departed from manufacturing specifics. The Plaintiff failed to identify a safer alternative, the company claimed. These claims were denied.
Massachusetts law prohibits punitive damages in the absence of wrongful death or special statutory provisions, Boston Scientific claims. The case should have been tried in Massachusetts because that’s where the company is based.
The case is Deborah Barba v. Boston Scientific Corporation, Superior Court of the State of Delaware in and for New Castle County, C.A. No. N11C-08-050 MMJ.#
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