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Calif. AG's pelvic mesh marketing lawsuit unjustified, J&J says
Jun 6, 2016 | Legal NewsLine
By Rebecca Campbell
California Attorney General Kamala D. Harris recently announced that her office has taken action against Johnson & Johnson, suing the company for alleged false advertising and deceptive marketing of it surgical mesh products for women. -
American Medical Systems Settles over 100 Pelvic Mesh Suits
Jun 6, 2016 | Legal Reader
By Jay W. Belle Isle
American Medical Systems settles over 100 pelvic mesh suits, per an announcement this past Friday. The suits were part of a multidistrict litigation (MDL) in West Virginia. AMS, owned by Endo International PLC, faced litigation due to injuries caused by its vaginal mesh devices, including the Apogee and Perigee systems, as well as the MiniArc Sling and the IntePro Y Sling. -
3 Sh*tty Postpartum Things All New Mothers Experience, But Never Talk About
Jun 6, 2016 | Elite Daily
By Rebecca Lackie
...Pelvic organ prolapse is a condition where the bladder, bowel and uterus start to slip down into the vagina. And in severe cases, they will start to protrude outside the body. The CFA reports the incidence is as high as 50 percent after childbirth. -
Welcome to Mesh News Desk, June 2016
Jun 6, 2016 | Mesh Medical Device News Desk
By Jane Akre
...While trials against Johnson & Johnson will begin this summer in Charleston, WV and Philadelphia, PA, we have a couple of state Attorneys General offices who have just filed lawsuits against J&J for fraudulently marketing their defective products to residents of California and Washington State.
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Calif. AG's pelvic mesh marketing lawsuit unjustified, J&J says
Jun 6, 2016 | Legal NewsLine
By Rebecca Campbell
California Attorney General Kamala D. Harris recently announced that her office has taken action against Johnson & Johnson, suing the company for alleged false advertising and deceptive marketing of it surgical mesh products for women.
The mesh, also known as transvaginal mesh or pelvic sling, is commonly used to treat women for stress urinary incontinence (SUI) and pelvic organ prolapse (POP).
According to the lawsuit, the company misrepresented the safety of these devices by failing to warn both patients and doctors of possible severe complications caused by the mesh, including permanent pain with intercourse and/or loss of sexual function, chronic pain, permanent urinary or defecatory dysfunction and potentially devastating impact on overall quality of life.
In the case, California led a coalition of 46 states and the District of Columbia. They are seeking injunctive relief and monetary penalties that will ensure J&J stops its alleged practices.
Speaking to Legal Newsline, J&J spokeswoman Samantha Lucas said that the decision to sue her company was unjustified.
“The company plans to vigorously defend itself against the allegations,” Sam said. “The evidence will show that Ethicon acted appropriately and responsibly in the marketing of our pelvic mesh products.”
According to J&J, the use of implantable mesh is often the preferred option to treat certain female pelvic conditions, including pelvic organ prolapse and stress urinary incontinence, and is backed by years of clinical research.
Harris asserts, though, that the health of women was put at risk by J&J.
“Johnson & Johnson put millions of women at risk of severe health problems by failing to provide critical information to doctors and patients about its surgical mesh products,” Harris said.
“Johnson & Johnson’s deception denied women the ability to make informed decisions about their health and well-being. My office will continue to hold companies accountable for misleading consumers and patients for financial gain.”
J&J argues that synthetic mid-urethral slings are the worldwide standard of care for surgical treatment of stress urinary incontinence.
“The American Urogynecologic Society (AUGS), the nation’s leading association of urogynecology doctors, has stated ‘the polypropylene mid-urethral sling has helped millions of women with stress urinary incontinence regain control of their lives by undergoing a simple outpatient procedure that allows them to return to daily life very quickly,'” Sam said.
Ethicon is concerned that Harris' decision to file a lawsuit will keep women from obtaining treatment for the often-debilitating symptoms of stress urinary incontinence, added Sam.
According to Harris’ office, J&J sold 787,322 of these devices nationwide between 2008 and 2014, which included 42,000 in California. Worldwide, over two million women have been implanted with these mesh products.
In addition to this lawsuit, J&J faces more than 35,000 personal injury lawsuits in state and federal court related to its surgical mesh products.
http://legalnewsline.com/stories/510782352-calif-ag-s-pelvic-mesh-marketing-lawsuit-unjustified-j-j-says
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American Medical Systems Settles over 100 Pelvic Mesh Suits
Jun 6, 2016 | Legal Reader
By Jay W. Belle Isle
American Medical Systems settles over 100 pelvic mesh suits, per an announcement this past Friday. The suits were part of a multidistrict litigation (MDL) in West Virginia. AMS, owned by Endo International PLC, faced litigation due to injuries caused by its vaginal mesh devices, including the Apogee and Perigee systems, as well as the MiniArc Sling and the IntePro Y Sling.
The parties filed a joint motion to dismiss after reaching settlement agreements in around 135 cases involving claims that the mesh devices are defective. Injuries include incontinence, chronic pain and other problems.
At the time of this writing, no comments were available from the multiple firms representing the settling clients.
In reverse chronological order:AMS settled 100 suits in July 2015;In May 2015, U.S. District Judge Joseph R. Goodwin, the judge presiding over the MDL, was told by AMS’ attorneys that around 108 cases were settled;AMS told Judge Goodwin in April 2015 that it had “compromised and settled all claims” in roughly 360 cases;In April 2014, Endo announced that it had settled several suits by agreeing to an $830M payout. There were approximately 20,000 claims in that “chunk” of litigation.
Endo International PLC maintains its global headquarters in Dublin, Ireland and has a history nearly a century long. Its United States headquarters are located in Malvern, Pennsylvania. Endo has several thousand employees across the globe.
American Medical Systems, Inc., one of Endo’s subsidiaries, produces mesh devices used to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI).
http://www.legalreader.com/american-medical-systems-settles-over-100-pelvic-mesh-suits/
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3 Sh*tty Postpartum Things All New Mothers Experience, But Never Talk About
Jun 6, 2016 | Elite Daily
By Rebecca Lackie
The reality of what can happen to your body after childbirth is often not discussed. There is so much focus on the delivery itself, that the aftermath following the big moment is often overlooked.
It can happen when you cough. It can happen when you sneeze. It can happen if you go for a run. You should completely forget about jumping on a trampoline.
There are three horrifying, yet common things that can happen after childbirth, but no one seems to talk about them. The thrill of the baby and motherhood itself overlooks the fact that most mothers still suffer from embarrassing and painful bodily conditions as a result of childbirth.
Those three things are:1. Wetting your pants.
The Continence Foundation of Australia (CFA) reports that the incidence of incontinence after childbirth is one in three. This is extremely high. If you look around at your girlfriends with children, chances are someone is having issues.
One of my patient’s (let’s call her Jane) was experiencing stress incontinence (leaking with coughing, sneezing and exercise). This started after the delivery of her son, Harry. She told me she couldn’t wear a G-string because she couldn’t wear one without a pad big enough to catch her leaks. She hadn’t been able to wear a G-string for two years now due to needing to wear pads daily, and was terrified she was going to have a accident in public, all at the age of 36.2. Something falls out of your body.
Pelvic organ prolapse is a condition where the bladder, bowel and uterus start to slip down into the vagina. And in severe cases, they will start to protrude outside the body. The CFA reports the incidence is as high as 50 percent after childbirth.
Having your bladder, your uterus or your bowel attempting to escape from your body is a completely unfathomable event that leaves the owner of said bladder, uterus or bowel feeling completely betrayed by their own body.
I see this often in my practice, and it is the reason I always have tissues on hand. In the words of one of the mom’s I saw as a patient (who has two small children):
When I first felt like something wasn’t right, I got my husband to look and he also thought my vagina looked weird. I got on Google and discovered it could be a prolapse. When the physiotherapist confirmed it was my bladder I could see, I cried nonstop for about two weeks. I can’t exercise without feeling like something is going to fall out. I can’t lift my children. I feel like it has ruined my life.3. Loss of bowel control.
Research that was published in 2002, reported that fecal incontinence occurs in 3 percent of women three months after childbirth, and inability to control wind occurred in 25 percent of women.
Inability to control wind might not sound like a big deal, but another patient I saw five months after the birth to her second child (let’s call her Mary) voiced the reality of this problem. She told me she couldn’t go to the gym because since she gave birth, she couldn’t control her wind. It’s loud and it is humiliating. It tends to happen whenever she changes position, and at the gym, you change positions all the time. She would never know when it was going to happen, so she just doesn’t go now.
If you are pregnant and reading this with your mouth open in disbelief, read on, There are a few things you should discuss with your doctor.
Research has shown that there any ways to know before childbirth if you’re at greater risk of developing one of these problems afterwards. If you already have one or more identified risk factors, you are more likely to experience incontinence or prolapse after delivery.
Risk factors include: If you are already experiencing urinary or fecal incontinence, if you are small in stature, if you start childbearing later in life, if you are overweight, if there is a history of incontinence or prolapse in your family (particularly your mom or your sister) or if the estimated weight of your baby is more than 8.8 pounds.
If you are saying yes to things on this list, it might be worth discussing these risk factors with your doctor and what might be done to try to try to compensate. Yes, I am nicely suggesting you discuss whether an elective caesarean section might be the preferred option for you. Or at the very least, discussing whether going to a C-section earlier rather than later if things are not progressing well would be your preferred option.
The Cochrane database reviews research and writes reports on this research, making it the highest level of evidence we have in healthcare. When looking at their published papers, they have found several things that are worth discussing with your doctor about your birth plan:
1. Giving birth in an upright position reduces the duration of labor and the need for epidurals.
2. Immersion in water during birth reduces the need for epidurals and other pain relief, and reduces the duration of labour.
3. Epidurals have been shown in the research to increase the chance that you will have an instrumental delivery.
Now, here is the important one that ties this all together:
4. The use of forceps (compared to vacuum extraction) causes more severe tearing and vaginal tearing, and causes more incontinence. There is also more chance of facial injuries to your baby.
It would seem the research supports avoiding instrumental delivery to reduce the incidence of pelvic floor problems. We can do this be encouraging water births, not lying on your back and without the use of forceps.
The CFA tells us there are other things we can do to reduce pelvic floor disorders. Manage your bowels, and in particular, constipation. Straining in order to pass a bowel motion pushes down on your pelvic organs and can weaken your pelvic floor. Manage your weight, as well. The heavier the load you are carrying, the higher the demand on your pelvic floor and the more pressure on your pelvic organs.
You should avoid physically demanding jobs that involve repetitive heavy lifting and hard physical training, since they have also been linked to pelvic floor disorders. Exercising the pelvic floor muscles has been shown to be effective, since strengthening these muscles lifts the pelvic floor and increases support to the organs.
Let’s start acknowledging that giving birth does not always give the outcome expected, and telling women they should be thankful they have a healthy baby when their uterus is falling out or they are wetting their pants does not necessarily make them feel better.
Let’s start focusing on what we can do to try to decrease the dismal statistics we are seeing. Don’t let it be the elephant in the room. Let’s start talking about this.
http://elitedaily.com/life/postpartrum-mothers-experience/1508452/
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Welcome to Mesh News Desk, June 2016
Jun 6, 2016 | Mesh Medical Device News Desk
By Jane Akre
What’s happening in June with Mesh News Desk!
Welcome to Mesh News Desk (MND), also known as Mesh Medical Device News Desk. For five years, MND has been covering the issue of pelvic mesh and will continue to do so until it is on the front page of every newspaper, every day. That’s where it belongs!
We’ve never seen such an important story that was ignored by mainstream media with hundreds of thousands of women, men and families adversely affected by a little “gold standard” medical device intended to fix a largely inconvenient condition of incontinence and pelvic organ prolapse. Please check out our friend (not advertiser), Whole Woman, for alternative treatments to prolapse and incontinence.
While trials against Johnson & Johnson will begin this summer in Charleston, WV and Philadelphia, PA, we have a couple of state Attorneys General offices who have just filed lawsuits against J&J for fraudulently marketing their defective products to residents of California and Washington State.
If you live in Kentucky, the Attorney General, Andy Beshear, would like to hear from you. Main switchboard 502-696-5300, http://ag.ky.gov/Pages/contact.aspx
One woman began the Washington State complaint four years ago and MND News Desk and Corporate Action Network alerted various AG offices in a nationwide effort to bring awareness to the misdeeds of seven mesh manufacturers. We understand 46 AGs are looking into similar actions.
Mesh settlements have been largely disappointing. The latest company to add insult to injury is Caldera which is offering women about $1,500 after legal fees. Complicating the issue is that women have been told to keep quiet so their individual case is not compromised in the settlement process. Meanwhile, attorneys will collect their 40% and the woman, for the most part, walks away with less than the law firm, even the law firm that just shuffled her case to another.
For that she has given up her voice AND signs a nondisclosure agreement that she can never speak up. “Samantha” is opting out of the Caldera limited settlement. Please follow her story.
For those of who are newly implanted and wondering if it could happen to you, or if you are beginning to have complications, I’m sorry. Doctors are still telling women, “It’s different mesh,” or “The bad mesh has been recalled.” Unfortunately this is not true. Ask if it’s polypropylene or a composite with polypropylene. Ask to see the recall notice. Your doctor will likely sense you are trouble and show you the door.
See the story “Top 10 Myths Women are Told Today about Pelvic Mesh” here.
Don’t hesitate to use the legal evaluation link on page one of Mesh News Desk to find a lawyer who is still taking cases since many are not.
We are still taking reports of autoimmune complications and please fill out those forms if you have developed Lupus, fibromyalgia, joint aches, pains, rashes, brain fog, tooth loss. Scientists will be evaluating the autoimmune issues very soon and we will announce that when it is official.
MND is also attempting to get lawyers interested in complications from hernia mesh. If you are a law firm taking those cases, please reach out here so we can put you on our radar!
Please use the Search Bar to explore any topic mesh-related. There are more than 700 stories posted over the last five years. You can also click on the Legal or Medical category title to see what has been filed under that category.
News on Mesh News Desk is not intended to substitute for information from lawyers and doctors. It’s founder is a journalist who is NOT mesh injured, however the community of injured is really awesome! Many women find relief just knowing they are not alone and learning from each other! There are some smart women here and we welcome your essays, opinions, contributions in any form. Ask a question to those who are on the Facebook site. Thank you for those who have written (you can do so anonymously).
Please refrain from using your actual name and posting any confidential information you receive from your law firm. It could negate the settlement agreement you may have signed.
Please sign up for the Mesh Newsletter (here) to keep you up on the latest here and thank you goes out to the many supporters who help bring light to mesh injuries of all kinds. Your generous support makes this effort possible.
Jane Akre
Editor, Mesh News Deskhttp://www.meshmedicaldevicenewsdesk.com/welcome-mesh-news-desk-june-2016/
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