Preview Newsletter
Ethicon Media Monitoring 09/12/16
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J&J Offers Second Major Settlement to Pelvic Mesh Injured Women
Sep 9, 2016 | Mesh Medical Device Newsdesk
Motions have been flying this week in the Johnson & Johnson Pelvic Mesh litigation filed in federal court in West Virginia. Johnson & Johnson has agreed to its second settlement to resolve an undisclosed number of lawsuits filed by women injured by its vaginal mesh implants. -
An Open Dialogue on Pelvic Health
Sep 10, 2016 | The Morning Call
By Dr. Tasscia Williams
The statistics are staggering: More than one in every three women have some kind of pelvic floor disorder. In fact, nearly one-quarter of American women have one or more PVDs that cause symptoms, according to the National Institutes of Health. -
People with pelvic health problems don’t have to ‘suffer in silence’: Oakville physiotherapists
Sep 12, 2016 | InsideHalton.com
By Julia Le
Incontinence doesn't have to be something you just accept as part of life. Oakville physiotherapists Anne Dorey and Julia Fiorelli specialize in pelvic health and hope to boost available local options in that field. -
Urinary incontinence, fecal incontinence, and pelvic organ prolapse awareness is lacking among most women: Study
Sep 9, 2016 | Bel Marra Health
By Devon Andre
Urinary incontinence, fecal incontinence, and pelvic organ prolapse awareness is lacking among most women. Knowing the signs and symptoms of these conditions can help start the treatment sooner, but unfortunately, many women are unfamiliar with these conditions and their symptoms, so treatment is often delayed. This lack of knowledge was seen to be more common among women of color.
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J&J Offers Second Major Settlement to Pelvic Mesh Injured Women
Sep 9, 2016 | Mesh Medical Device Newsdesk
Healthcare giant offers second settlement to resolve pelvic mesh injury cases.
Undisclosed Settlement is approved by multidistrict litigation judge.
Motions have been flying this week in the Johnson & Johnson Pelvic Mesh litigation filed in federal court in West Virginia.
Johnson & Johnson has agreed to its second settlement to resolve an undisclosed number of lawsuits filed by women injured by its vaginal mesh implants.
J&J and its Ethicon division has come to agreement with Athens, Georgia law firm Blasingame, Burch, Garrard & Ashley (BBGA).
Mesh News Desk has an inquiry into J&J for comment.
While settlement amounts are confidential, last April a $5 million settlement was revealed in New Jersey court documents in a private agreement with one injured woman. In January of this year, J&J agreed to a $120 million settlement, to resolve 2,000 to 3,000 pelvic mesh cases, its first big mesh settlement announced. The latest settlement is reported by sources to be close to that amount to resolve fewer cases.
“The exact allocation among and distribution to covered claimants, or any other persons or entities asserting a claim of subrogation or reimbursement, has not been finalized at this time.”
J&J is the last of seven manufacturers to offer settlements to resolve claims of injury and infection. As of today, the healthcare giant faces 34,535 product liability cases filed in federal court in West Virginia, where pelvic mesh cases are consolidated in multidistrict litigation (94,265 total), as well as 8,931 cases filed in New Jersey, Internationally, cases have been filed by law firms representing injured women in Canada, Australia, Israel, among other countries.
Women who have filed lawsuits claim the mesh shrank, caused organ damage, constant pain and infection. In many women, the permanent implants cannot be removed.
In Pretrial Order #237, filed September 7, Judge Joseph Goodwin, who is overseeing multidistrict litigation in WV, approved the Confidential Settlement Agreement with Ethicon. Judge Goodwin also appointed (PTO #236) Special Master Cathy Yanni to allocate and divide the settlement payouts. A woman’s medical condition, the number of surgeries she has had to endure as a result of her pelvic mesh implant will all be considered. Any outstanding liens, whether medical or to a lending company, will be negotiated as well.
The Special Master will receive $300 per claim plus $10,000 per calendar quarter and $2,000 per appeal.
Ms. Yanni has mediated over 10,000 matters over the past 17 years and has been appointed by Judge Joseph Goodwin to act as the Special Master for certain settlement agreements between Covidien, C.R. Bard, Boston Scientific and Coloplast and certain Plaintiffs’ counsel. She has also mediated DePuy Orthopaedics Inc ASR Hip Implant Products Liability Litigation, another company owned by Johnson & Johnson, as well as Medtronic Infuse litigation and Gadolinium Contrast Dyes product liability litigation, Bextra and Zicam litigation.
In another filing, Ethicon, moves to have Dr. Anne Weber excluded as an expert in some upcoming pelvic mesh trials.
In PTO #235, Judge Goodwin announces a September 13 and 14, 2016 status hearing to access the progress made by both sides in settling this massive MDL, the largest ever filed in one court.
In February, 2015, Judge Goodwin predicted a “Rocky Path” if both sides did not meet some agreements. See MND story here. ##
http://www.meshmedicaldevicenewsdesk.com/jj-offers-second-major-settlement-pelvic-mesh-injured-women/
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An Open Dialogue on Pelvic Health
Sep 10, 2016 | The Morning Call
By Dr. Tasscia Williams
The statistics are staggering: More than one in every three women have some kind of pelvic floor disorder.
In fact, nearly one-quarter of American women have one or more PVDs that cause symptoms, according to the National Institutes of Health.
But what is a pelvic floor disorder?
Pelvic floor disorders are weaknesses or tears in the pelvic floor muscles. The most common symptom that women feel is the sensation of “a bulge” or that “something is falling out of my vagina.”
Those aren’t the only symptoms, however. Here are other common symptoms women may feel, including:Vaginal or pelvic pressureUrinary symptoms such as leakage or urgencyIncontinenceConstipationInability to completely empty the bladder after urinationIncreased pain after sittingDiscomfort or relief after a bowel movementReduced interest in sexPain associated with sexPain in the pelvic area.
Some of the causes of pelvic floor disorder include pregnancy and childbirth, obesity, advanced age and chronic constipation. In the cases of obesity and chronic constipation, both put pressure on the pelvic floor, which could cause symptoms.
More severe cases of pelvic floor disorders may include pelvic organ prolapse, where organs including the bladder, rectum, small bowel and the uterus can herniate to or beyond the vaginal walls.
Some non-invasive treatment options can bring temporary relief, such as Kegel exercises, medications and vaginal pessary. However, in some cases reconstructive surgery is the best option. Pelvic reconstructive surgery can be performed either vaginally or laparoscopically.
Reconstructive surgery may include repairing the prolapse and building back pelvic floor support.
Other surgeries can also work well to treat problems of urinary leakage caused by stress incontinence. The two most common surgeries offered are a mesh strap or sling to hold the urethra in its normal position and a procedure called colposuspension, where the surgeon puts the bladder back in its correct position.
If you experience one or more of these symptoms and they disrupt your lifestyle, see your gynecologist, who can discuss individualized treatment options with you.
http://www.mcall.com/health/inspirehealth/tips/mc-inspire-health-an-open-dialogue-on-pelvic-health-story.html
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People with pelvic health problems don’t have to ‘suffer in silence’: Oakville physiotherapists
Sep 12, 2016 | InsideHalton.com
By Julia Le
Incontinence doesn't have to be something you just accept as part of life.
Oakville physiotherapists Anne Dorey and Julia Fiorelli specialize in pelvic health and hope to boost available local options in that field.
The pair met while taking specialized pelvic health courses and discovered a shared passion to help patients improve their quality of life.
The pair recently opened Oakville Pelvic Health in the Argus Medical Building.
They say patients come their way through referrals from other physiotherapists, massage therapists, specialists, general practitioners and word-of-mouth.
"Sometimes I think a lot of people suffer in silence," Dorey told the Oakville Beaver. "They don't know there is a real treatment option or they just accept this is the way it is."
Dorey and her partner Fiorelli hope to better inform the public about treatments for what they call "pelvic floor dysfunction."
The duo maintains treatment options exist for those who experience bladder control issues or pelvic pain.
"This is not your new normal," said Dorey, of dysfunction that can occur due to bladder control issues, especially as related to pregnancy, as well as conditions such as stress, urinary incontinence, urge urinary incontinence, urinary urgency and frequency, bladder pain, persistent pelvic plain, painful intercourse, vulvar pain, pelvic organ prolapse, low back, hip and sacroiliac joint (SI) joint pain and more.
Fiorelli said pelvic heaviness is a common complaint and could be due to a prolapse of an organ like the bladder or uterus.
The field of pelvic health field has been expanding in Ontario in recent years, however Dorey and Fiorelli admit not everyone is comfortable with examination, diagnosis and treatment processes, particularly if internal examination is involved.
The pair remains committed in the belief that there are means to improve quality of life for patients.
For more information, visit www.pelvichealth.ca.
http://www.insidehalton.com/news-story/6848975-people-with-pelvic-health-problems-don-t-have-to-suffer-in-silence-oakville-physiotherapists/
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Sep 9, 2016 | Bel Marra Health
By Devon Andre
Urinary incontinence, fecal incontinence, and pelvic organ prolapse awareness is lacking among most women. Knowing the signs and symptoms of these conditions can help start the treatment sooner, but unfortunately, many women are unfamiliar with these conditions and their symptoms, so treatment is often delayed. This lack of knowledge was seen to be more common among women of color.
These conditions are most common pelvic floor disorders, and insufficient knowledge is one of the greatest barriers when it comes to receiving proper care. Corresponding author Dr. Marsha K. Guess explained, “If we can improve knowledge about pelvic floor disorders, we may be able to improve outcomes for all women.”
Roughly 25 percent of women over the age of 20 suffer from pelvic floor disorders, and the number of cases is expected to rise in the next 40 years. Annually in the U.S., over $12 billion is spent on treating just urinary incontinence alone, and the cost is expected to rise as well.
The researchers conducted a cross-sectional study consisting of 431 women. They uncovered that just over 71 percent of the women lacked knowledge regarding urinary incontinence and 48 percent lacked knowledge regarding prolapsed organs. Women of color were found to have much less awareness about these disorders, compared to white women.
First author Charisse Mandimika added, “Improving knowledge about health problems has proven effective in promoting behavioral change, reducing levels of disease symptoms, and improving compliance with treatment for other chronic diseases. This study shows that African American women and non-white groups in general are not benefiting from this knowledge.”
Dr. Guess concluded, “Another very concerning finding is that the majority of women who experienced urinary incontinence had not received treatment. Culturally sensitive educational interventions are urgently needed to raise awareness, and address these disparities in knowledge head on.”Common treatments for pelvic floor disorders
There are different urinary incontinence treatments depending on what led to urinary incontinence in the first place. In many situations, behavioral remedies such as bladder retraining and Kegel exercises can help. Bladder retraining is simply using the washroom at regular timed intervals. This is also referred to as “timed voiding”. Kegel exercises are movements to strengthen the muscles that help hold in urine.
Lifestyle changes play a big role in treatment for some people who struggle with UI. You may try cutting down on caffeine consumption, consuming less fluid or more fluids, or losing weight, and find improvement.
Some people are prescribed urinary incontinence medication in combination with exercises, but it is important to know that there can be side effects, including dry mouth. There is also topical estrogen for the skin that comes as a ring, patch, or vaginal cream. It reinforces the tissue in the urethra and vaginal areas. Medical devices, including urethral and vaginal inserts, have been known to help women with incontinence, particularly during times of physical activity.
Although less common, radiofrequency therapy, which can firm up tissue in the lower urinary tract, botox injected into the bladder muscle, bulking agents injected into the tissue around the urethra, as well as the sacral nerve stimulator – a device implanted under the skin to stimulate the nerve that controls the bladder – are also possible treatment options.
Unfortunately, there are situations where urinary incontinence surgery is required. The three most common procedures are: sling, colposuspension, and artificial sphincter. Sling involves inserting something into the neck of the bladder to support the urethra in order to stop the leaking.
Colposuspension is a bladder neck lift. It is more invasive as it requires an incision in the lower abdomen and stitches through the walls of the bladder neck. Artificial sphincter is an artificial valve inserted to control the flow of urine from the bladder into the urethra. This is only recommended when nothing else works, because it comes with some serious risks.
Treatment for fecal incontinence involves lifestyle and dietary changes to relieve diarrhea or constipation, exercise programs to strengthen the muscles that control the bowel, medications to control diarrhea or constipation, and surgery.
Fecal incontinence products available include anal plugs and disposable pads. Your doctor will also want to treat the underlying condition that is causing fecal incontinence.One of the treatment options for prolapsed bladder is not taking any course of action at all if there are no symptoms present. Other common forms of treatment include behavior therapy, Kegel exercises, pelvic floor physical therapy, use of a vaginal support device, or drug therapy, which may involve estrogen replacement.
Surgery is another option for a prolapsed bladder. Surgery options include open surgery, minimally invasive surgery, laparoscopic surgery, and robot-assisted laparoscopic surgery.
The goal of the surgery is to repair any damaged muscles or tissue, and augment the bladder with a surgical material.
http://www.belmarrahealth.com/urinary-incontinence-fecal-incontinence-pelvic-organ-prolapse-awareness-lacking-among-women-study/
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