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Ethicon 12/8
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Ethicon Official In Pa. Mesh Trial Defends Product's Safety
Dec 7, 2015 | Law360
By Matt Fair
A top engineer with a Johnson & Johnson subsidiary told a Philadelphia jury on Monday that safety concerns over a pelvic mesh implant blamed for untreatable injuries in an Indiana woman had been rigorously vetted before the product went to market in 2005. -
'I feared I was the only one living with incontinence'
Dec 8, 2015 | Independent (Ireland)
By Ailin Quinlan
...Wicklow mum Claire Reid experienced pelvic floor weakness - which causes urine leakage - when she was 31 and pregnant with her first child, now aged 15... -
What happens when your vagina 'falls out'? Everything you need to know about complete uterine prolapse
Dec 7, 2015 | The Mirror
By Kirstie McCrum
Childbirth is daunting to say the least, but one woman's tale of her own struggles post-labour has left many asking worried questions.
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Ethicon Official In Pa. Mesh Trial Defends Product's Safety
Dec 7, 2015 | Law360
By Matt Fair
A top engineer with a Johnson & Johnson subsidiary told a Philadelphia jury on Monday that safety concerns over a pelvic mesh implant blamed for untreatable injuries in an Indiana woman had been rigorously vetted before the product went to market in 2005.
After facing questions from a plaintiff’s attorney on Friday, Ethicon Inc. research and development director Scott Ciarrocca testified that company officials and the product’s developers had properly concluded that the Prolift pelvic mesh implant was a safe and effective way of treating organ prolapse in women.
“We felt that the benefits outweighed the risks,” he said. “I think we had come up with a very good, safe and effective way for treating a very difficult condition.”
Ciarrocca’s testimony on Monday came after Adam Slater, an attorney with Mazie Slater Katz & Freeman LLC representing plaintiff Patricia Hammons, posed questions on Friday over emails and other documents suggesting that Prolift developers had raised concerns about potential complications from the makeup of the mesh.
Goldman Ismail Tomaselli Brennan & Baum LLP attorney Tarek Ismail, however, pointed to a 2004 message from one of the product’s lead developers stating that he’d seen positive results using the so-called Prolene mesh versus several other options.
Hammons had filed suit in Philadelphia in May 2013, alleging that shards of the Prolift mesh, which was implanted between her bladder and vagina in 2009 in an effort to correct sagging of her internal organs, had become implanted in her bladder.
Attorneys for Hammons contend that her injuries have caused untreatable urinary dysfunction and had all but prevented her from having sex.
Trial in the case got underway last Tuesday and is expected to last another week.
Ciarrocca testified that, no matter the material used in developing the product, there was always a risk associated with implanting material in the body.
“I just think it’s an expected thing associated with implanting a foreign body,” he said. “We knew that there was always the potential for that with any mesh-based repair. That was well understood by both the [development] team and the leadership team.”
Ismail also walked Ciarrocca and the jury through portions of a study concluding that patients had largely had positive results after receiving the mesh to treat organ prolapse. Among the findings was a low incidence of mesh exposure, or when a portion of the implant becomes visible in the vaginal canal.
“It describes them as having significant improvements,” Ciarrocca said.
Slater had used the study during testimony on Friday to question whether it had shown a failure rate in excess of the 20 percent ceiling the company had set for reevaluating the project prior to taking Prolift to market in March 2005.
Ciarrocca, however, said that the 20.1 percent rate extrapolated from the data was only available in 2006 after the company had already gone ahead with the project.
Prior data, he said, had shown lower rates allowing the company to proceed.
The case was presented for the plaintiffs by Adam Slater of Mazie Slater Katz & Freeman LLC.
The case was presented for the defendants by Tarek Ismail of Goldman Ismail Tomaselli Brennan & Baum LLP.
The case is Hammons v. Ethicon Inc. et al., case number 130503913, in the Court of Common Pleas of the State of Pennsylvania, County of Philadelphia. -
'I feared I was the only one living with incontinence'
Dec 8, 2015 | Independent (Ireland)
By Ailin Quinlan
Imagine having an uncomfortable medical condition which affects your social life, curtails your fitness regime and keeps you in a state of anxiety - but which you endure for over a decade because you're embarrassed to talk to the doctor about it.
Wicklow mum Claire Reid experienced pelvic floor weakness - which causes urine leakage - when she was 31 and pregnant with her first child, now aged 15.
The pelvic floor, explains Wicklow GP and medical expert on Operation Transformation Dr Ciara Kelly, is like a sling which sits across your pelvic area, holding your organs - bladder and uterus for example - in place.
"What happens to some women following childbirth is that their pelvic floor becomes stretched and lax," says Dr Kelly, emphasising, however, that women who haven't given birth can also experience the condition.
Pelvic floor weakness is mainly caused by pregnancy and childbirth, menopause, being overweight or as a result of a hysterectomy.
Symptoms can include accidentally leaking urine when you laugh, sneeze or cough; a frequent need to go to the toilet; reduced vaginal sensation or difficulty emptying your bowel or your bladder.
At the time Reid thought what she was going through was an inevitable part of pregnancy - in fact, according to a new survey, 'Being a Mum in 2015', some 41pc of women are not even aware that a solution exists - so when the problem continued through the births of her second and third children, she didn't do anything about it.
In fact the Greystones, Co Wicklow woman endured the discomfort and stress for more than 10 years before eventually seeking help at the age of 43.
"I went to see my GP about it three or four years ago," she says, adding that by that stage she was utterly fed up of the restrictions the condition imposed on her lifestyle.
"I was able to exercise but I couldn't go for a really long walk without needing to go to the bathroom for instance.
"I restricted my intake of coffee and water. Socially, it also affected me; if I was going into a restaurant or a bar I'd immediately need to know where the bathroom was, and of course the last thing I always had to do before I left home was go to the bathroom - there would be a sense of urgency," says the office administrator and mother of three.
So she reluctantly sought a consultation with her doctor, believing, she recalls, "that I was the only woman in the whole world who'd ever gone to the doctor about this.
"However, I was sick and tired of it, and fed up of not having the freedom even to go for a long walk."
To her surprise, the world didn't cave in - instead her GP simply observed that it was a common problem. And it is.
The latest Irish research has revealed that more than 70pc of women surveyed have experienced accidental leakage from everyday activities, such as walking, running, exercising, jumping on trampolines, laughing, coughing or sneezing. TV presenter Bláthnaid Ní Chofaigh recently revealed her own battle with incontinence and urged people to speak out about it.
Pelvic floor weakness is also a huge problem globally - one in three women worldwide experience pelvic floor weakness, which can cause some concern - or be completely debilitating.
The Irish research also revealed that 65pc of women including mothers and mothers-to-be wouldn't discuss pelvic floor weakness with their healthcare professional.
"We forget that GPs hear so many personal problems that they don't think anything of it," observes Reid.
"For me I was quite embarrassed, but when the doctor said it was very normal, I immediately took comfort from that. I really had felt I was the only one - even with your friends you wouldn't feel comfortable talking about the subject."
The doctor recommended medication to take away the sense of urgency around urination - characteristic of the condition - as well as special exercises to strengthen the pelvic floor.
Reassured, Claire felt emboldened to speak about it with friends - some of whom confided in return that they too had experienced it - and to carry out some research on the internet.
Within a month of starting on the medication and doing the exercises, she noticed an improvement.
"That sense of urgency was gone and I felt that if I needed to go to the bathroom I could wait - I had that confidence [with] the new regime."
There's a huge lack of public awareness about the fact that pelvic floor weakness is a problem which can be dealt with, says Dr Kelly:
"I have written about this and have spoken about it on television and radio. I regularly get feedback from women saying they didn't know there was help out there."
The research, which was carried out among 600 women during October and November 2015 in order to gauge awareness of pelvic floor weakness among women, mothers and mothers-to-be throughout Ireland, shows that 87pc of women surveyed would use a clinically proven, non-invasive solution to prevent pelvic floor weakness from reoccurring.
According to Dr Kelly, there is a variety of solutions to the problem, ranging from pelvic floor exercises to physiotherapy, neuro-muscular stimulation, drugs and surgery.
"We'd prefer to avoid surgery or medication so the first line is exercise, physiotherapy or neuro-muscular stimulation, where you use a machine that passes an electrical current through the muscles of the pelvic floor.
"This stimulates them to contract more strongly than they would do otherwise," she explains.
"Too often, women think that pelvic floor weakness is a condition they have no choice but to put up with, when really there are solutions out there," says Dr Kelly.
"Women aged from 30 to 45-plus frequently visit my practice with signs and symptoms of pelvic floor weakness. It can have a huge impact on their lives with their family, with their partner and at work," she explains, adding that she's also seen younger women who are experiencing the condition.
"I see women in their 20s who have never had children, having issues. This is not exclusively a problem for older women or women who have had children.
"Younger women often think it's a problem for older women, which exacerbates their reluctance to do anything about it. You're not alone - there are loads of people like you - so come forward and you will get help," she exhorts.
"I really don't see enough of this coming in the door. People are not talking about it."
Don't suffer in silence
Don't feel embarrassed - visit your GP to get a diagnosis and to discuss the many different options for tackling the problem. These include:
• Special exercises to strengthen the pelvic floor
• Neuro-muscular stimulation
• Practice bladder drill - look at your fluid intake
• Medication can remove the uncomfortable sense of urgency around urination
• Surgery, which involves inserting a sling which is like a hammock support for the bladder. This procedure is done under anaesthetic and requires an overnight stay in hospital
• Botox injections - helps relax the bladder, enables it to hold more fluid
Health & Living
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Dec 7, 2015 | The Mirror
By Kirstie McCrum
Childbirth is daunting to say the least, but one woman's tale of her own struggles post-labour has left many asking worried questions.
Mum Allison Henry has described how, post-birth, her vagina 'fell out' - describing it as feeling like "someone had rammed a pitchfork up [her] butt".
Allison wrote on the MomLogic.com website, which no longer exists, that her problems came from nowhere towards the end of her second pregnancy.
Following 15 weeks of bleeding and constipation, she gave birth to a healthy boy, slightly prematurely - but then realised there was still something amiss.
She says she was using the loo when she noticed that "there wasn't really a hole there - it felt kind of flat", like something was blocking her vaginal canal.
But something more disturbing came later in the year, when she describes: "It was like my insides were on the outside and they were coming out", according to Broadly.
At this point, she went to the doctor and described what it felt like: "My vagina is falling out of my body!"
Alison was treated and came through the medical issue.
After an emergency appendectomy, which caused gangrene and an untwisted bladder, a hysterectomy, many surgeries and, eventually, a new surgically-formed vagina and labia, she was fit and well once again.
The medical term for what happened in Alison's case is a 'complete uterine prolapse'.
According to the NHS, a pelvic organ prolapse is bulging of one or more of the pelvic organs - the uterus, vagina, bowel and bladder - into the vagina.
Symptoms may include a sensation of a bulge or something coming down or out of the vagina, which sometimes needs to be pushed back.
It can also cause discomfort during sex and make problems when passing urine, such as slow stream, a feeling of not emptying the bladder fully, needing to urinate more often and leaking a small amount of urine when you cough, sneeze or exercise.
As far as treatment is concerned, the NHS says: "If the womb (uterus) is prolapsed, then removing it during... a hysterectomy often helps the surgeon to give better support to the rest of the vagina and reduce the chance of a prolapse returning."
Up to half of all women who have had children are affected by some degree of prolapse according to the journal Menopause .
A prolapse like this can be associated with age, as well as menopause, obesity, and pelvic surgery among other issues.
Los Angeles–based obstetrician and gynecologist Dr Jessica Schneider told Broadly that some women complain that they feel something or have a bulge in the vagina.
"What is falling will determine if there are urinary, sexual, or defecatory dysfunctions."
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