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Toms River Woman Awarded $13.5 Million in Vaginal Mesh Case Against Johnson & Johnson
Feb 22, 2016 | New Brunswick Today
By Dave Schatz
On February 10, a Philadelphia jury found that Johnson & Johnson (J&J) manufactured a defective TVT pelvic mesh device, and awarded a Toms River woman $13.5 million. -
Mentor Worldwide Must Pay $4.4M Over Defective Pelvic Mesh
Feb 22, 2016 | Legal Reader
By Jay W. Belle Isle
Earlier this week, a federal jury in Georgia found in favor of a plaintiff in a suit against Johnson & Johnson’s division Mentor Worldwide LLC. Mentor Worldwide must pay $4.4M over defective pelvic mesh. The plaintiff, Tessa Taylor of Florida, suffered incontinence and recurring infections as a result of the mesh device called the ObTape sling. Taylor’s case is one of hundreds against the J&J division. -
Federal jury awards Florida woman $4.4 million in vaginal mesh case
Feb 22, 2016 | Ledger-Enquirer
By Chuck Williams
A federal jury in Columbus returned a multi-million dollar verdict last week against a California company that manufactured, marketed and sold a vaginal sling device that it later pulled off the market. -
Caldera Medical - Take $11.5 Mill Mesh Settlement or Nothing!
Feb 22, 2016 | Mesh Medical Device News Desk
By Jane Akre
Class Action Settlement Announced for Caldera Mesh Survivors Women implanted with a Caldera Medical pelvic mesh product have until May 2, 2016 to submit a claim to a limited settlement that is being offered by the company. -
'I felt my bladder slip out of me': Mom who suffered pelvic organ prolapse at 28 reveals how the horrific condition 'shattered' her confidence and nearly ruined her sex life
Feb 22, 2016 | Daily Mail
By Erica Tempesta
...Carolyn's surgical options include having a sling made out of mesh inserted inside her to hold up her bladder and rectum and a hysterectomy to remove her uterus. For the time being, Carolyn said he gave her a pessary, a removable plastic ring that is placed into the vagina to support the uterus or bladder and rectum and help decrease urine leakage. -
Women’s hidden epidemic: Pelvic organ prolapse
Feb 22, 2016 | Toledo Blade
Pelvic organ prolapse occurs when the natural support of the vagina is lost, resulting in “sagging” or herniation of the bladder, cervix, uterus, small bowel, or rectum, into the vagina. Your doctor may have also called this a cystocele, rectocele, or enterocele.
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Toms River Woman Awarded $13.5 Million in Vaginal Mesh Case Against Johnson & Johnson
Feb 22, 2016 | New Brunswick Today
By Dave Schatz
On February 10, a Philadelphia jury found that Johnson & Johnson (J&J) manufactured a defective TVT pelvic mesh device, and awarded a Toms River woman $13.5 million.
The award includes $10 million in punitive damages that J&J must pay.
The plaintiff, Sharon Carlino, now 58, had the TVT device implanted during a hysterectomy in 2005 at Jersey Shore University Medical Center, according to a report on Mesh Medical Device Newsdesk.
“The jury found the warnings to her doctor were defective and [Dr. Andrew Blechman] said he would never have implanted the transvaginal polypropylene tape he used to treat her incontinence if he had known of its risks,” reads the report.
But by 2007 she experienced feeling something “sharp” in her vagina because the mesh had eroded.
“After a partial removal surgery, in 2010 she felt the mesh eroding again and had a second removal surgery. By 2012 she felt pain and experienced dyspareunia or painful sex,” reads the report, adding that Carlino had a third surgery to remove the mesh.Carlino’s complaint said she developed permanent injury, corrective surgery and experienced mental and physical pain and suffering. The complaint also cites her substantial financial and monetary losses as a result of a myriad of medical services and expenses related to having the plastic-like device implanted.
But, “at the same time [J&J marketed] their products as safe, effective reliable medical devices that are minimally invasive. Knowing the mesh had problems, J&J nonetheless sold it through ‘carefully planned, multifaceted marketing campaigns and strategies,’” says the report.
“They [Ethicon] rolled out the defense they’ve been using in mid-urethral sling case, after mid-urethral sling cases and this verdict shows those defenses don’t hold any water,” Attorney Adam Slater, who is said to have helped the team of Specter and Richard Freese, told Mesh Medical Device NewsDesk.
“The truth comes out in the courtroom...This trial shows is that these damages are meaningful to jurors. The defendant manufacturers have completely failed to convince any jury that the injuries caused by this mesh are mild and or acceptable.”
J&J recently paid $120 million, in its first large, multi-case mesh settlement, to stop as many as 3,000 lawsuits from going to trial.
And in December, an Indiana woman who had a similar J&J mesh product implanted was awarded $12.5 million by a Philadelphia jury.
"The longer J&J waits to settle, the numbers are not in their favor. They don't seem to understand that," Jane Akre, the founder of Mesh Medical Device News Desk, told New Brunswick Today in an email.
"There will be more deaths, suicides, more information coming forward about the additives to the mesh which may be causing autoimmune reactions in some women."
Akre said that women are still being harmed by the J&J mesh products.
"Just in case the public has the wrong impression- mesh is still being used, doctors are telling women 'it's different mesh' or that's been taken off the market. That's not true," said Akre.
"Women are still being injured. Docs are still being schooled in how to implant mesh. And these are not minor injuries such as 'cant have sex'... I regularly talk to women sobbing on the phone, they cannot leave their beds, they are on Oxycontin or morphine, they can't work, husbands leave, they lose their homes."
"The situation really hasn't improved much except J&J and others have quietly removed some of the worst offenders from the market (and are exporting them elsewhere)," Akre said.
"If you look at Risperdal and DePuy hips, the stance is always to fight them one-by-one in court, until the day they settle," said Akre. "So someone is watching and counting the risk versus benefit. Consider the recent restructuring of their medical device division, the benefit may not be exceeding the risk...and the risk is growing."
Attorneys who won the case wrote, “Cited in the latest case was a published study that noted a high incidence – 15.6 percent -- of mesh erosion in women. The two cases are the first of scores slated to be tried in Philadelphia.”
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Mentor Worldwide Must Pay $4.4M Over Defective Pelvic Mesh
Feb 22, 2016 | Legal Reader
By Jay W. Belle Isle
Earlier this week, a federal jury in Georgia found in favor of a plaintiff in a suit against Johnson & Johnson’s division Mentor Worldwide LLC. Mentor Worldwide must pay $4.4M over defective pelvic mesh. The plaintiff, Tessa Taylor of Florida, suffered incontinence and recurring infections as a result of the mesh device called the ObTape sling. Taylor’s case is one of hundreds against the J&J division.
The ObTape sling was implanted in women to treat a condition called stress urinary incontinence, in which a small amount of urine leaks from the bladder during coughing, sneezing or other exertion. Mentor discontinued the ObTape sling in 2006.
According to her claim, Taylor was implanted with the ObTape sling in 2004. She spent the next seven years with back pain, bladder pain, bladder discomfort and problems urinating. She had several diagnoses of vaginitis and bladder inflammation and underwent treatment with several rounds of antibiotics.
In 2011, Taylor’s doctor once again diagnosed her with stress urinary incontinence – despite the fact that she still had the ObTape sling – and advised her to have the ObTape sling removed and replaced with another product. She sued Mentor in 2012 along with hundreds of other plaintiffs. The cases were consolidated in a multi-district litigation (MDL), the purpose of which is to save time and money in the pre-trial and discover phases.
The day before the ObTape MDL was formed, Mentor settled 111 of the cases. This was in January 2014 and Mentor agreed to set up a trust to manage and distribute the agreed upon funds in the settlements.
Mentor entered into an undisclosed settlement with plaintiffs Beryl Cole and Roger Gupton on November 12, 2015. This case was one of six bellwether cases, those designed to allow the parties to test the merits of their cases and to establish common claims, admissible evidence, etc. Plaintiff Cole was implanted with the ObTape sling in 2004 and said she suffered abscesses, scarring and infections, requiring multiple surgeries.
This wasn’t the first time Mentor settled a bellwether case before trial; the company settled one in July 2013. In June 2013, Mentor took the day winning a verdict against plaintiff Irene Morey. The jury found that Morey’s evidence didn’t show that Mentor was negligent in its design of the ObTape sling.
Apparently, Mentor’s luck ran out when it faced off with Tessa Taylor. The jury held that the ObTape sling was defectively designed and was the cause of her many injuries. The jury further found that Mentor failed to provide Taylor or her physician adequate warnings about the ObTape sling.
Taylor was awarded $400,000 in compensatory damages and $4M in punitive damages. The jury said that the large punitive damages award served as punishment to Mentor for its behavior and that it would “discourage others from behaving in a similar way.”
The tide may be turning for those women who have been injured by defective pelvic mesh. Earlier this month, Johnson & Johnson’s Ethicon division was hit with a $13.5M verdictfor damages caused. That was the second such verdict. In December, the company was hit with a $12.5M verdict over defective pelvic mesh.
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Federal jury awards Florida woman $4.4 million in vaginal mesh case
Feb 22, 2016 | Ledger-Enquirer
By Chuck Williams
A federal jury in Columbus returned a multi-million dollar verdict last week against a California company that manufactured, marketed and sold a vaginal sling device that it later pulled off the market.
After deliberating for less than three hours on Thursday, the six-woman, six-man jury awarded Teresa Taylor of Marianna, Fla., $4.4 million in compensatory and punitive damages, according to federal court records. Taylor filed suit in 2012 against Mentor Worldwide LLC., which sold the mesh devices that were designed to treat stress urinary incontinence.
The case was tried in the Middle District of Georgia in front of Judge Clay Land, who was appointed by a federal judicial panel to hear the more than 300 cases from across the country against Mentor. This is the second such case that has been tried in Land’s court. Mentor won the first case.
Taylor, and her attorney, Edward Blizzard of the Houston firm of Blizzard & Nabers, alleged that Mentor continued to market the device after they knew that it caused health issues. The devices were sold between 2003-2006.
The jury, which was comprised of residents of the Middle District, awarded Taylor $400,000 in compensatory damages and then hit Mentor with a $4 million punitive verdict.
The jury found that Mentor Worldwide was “motivated solely by unreasonable financial gain” and that conduct resulted in a high likelihood of injury.
“This is the first such jury verdict and we think it is a big deal for Mrs. Taylor and the other plaintiffs,” Blizzard said. “It is a big verdict in that it is the first against Mentor.”
A former Mentor employee from France testified that the company knew of the issues with the device, Blizzard said.
Blizzard said the jury telegraphed the verdict midway through deliberations when they sent a note to Land.
“They asked if they could have a calculator,” Blizzard said. “We thought that was an unusually good sign.”
Mentor discontinued the product in 2006. Three years later the company was sold to Johnson & Johnson.
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Caldera Medical - Take $11.5 Mill Mesh Settlement or Nothing!
Feb 22, 2016 | Mesh Medical Device News Desk
By Jane Akre
Class Action Settlement Announced for Caldera Mesh Survivors Women implanted with a Caldera Medical pelvic mesh product have until May 2, 2016 to submit a claim to a limited settlement that is being offered by the company.
The full text of the article is currently unavailable. Once available, the full text can be accessed here: http://meshmedicaldevicenewsdesk.com/
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Feb 22, 2016 | Daily Mail
By Erica Tempesta
A mother-of-two has revealed the shame and depression she faced after her vagina started falling out of her body following the birth of her second child.
Carolyn Sayre, a science and health writer living in New York City, was diagnosed with pelvic organ prolapse (POP) when she was only 28 years old. The condition occurs when one or more organs, including the bladder, uterus, and rectum, shift downward and bulge into or even out of a woman's vaginal canal.
The trauma of a second childbirth had caused the muscles and tissues that form a supportive hammock for my pelvic organs to collapse,' Carolyn explained in an essay for Self.com. 'Since my disorder was so advanced, my bladder was actually beginning to protrude outside of my body.'
Carolyn said that two weeks after the birth of her son, she was going to the bathroom when she saw a 'large bulge' coming out of her, recalling that 'it looked like a baby's head was crowing'.
The next day she met with her obstetrician who diagnosed her with a pelvic floor disorder, which plagues as many as one-third of women, according to the National Institutes of Health.
Carolyn said that for the next few weeks it felt like she was 'constantly sitting on an egg'.
'Every time I lifted my newborn or squatted down on the floor with my three-year-old I could feel my organs slipping out of me,' she wrote.
Carolyn went on to say that because of her condition her bladder never felt empty, and she would often leak urine and sometimes even feces.
She admitted that like most women with the disorder, she felt 'ashamed', by her physical ailment, but she eventually went to see a urogynecologist specializing in POP. After a physical exam in which he asked her to push and tighten her vaginal muscles while his fingers were in her vagina and rectum, he advised her to start seeing a physical therapist who teaches women how to 'strengthen their pelvic floor'.
Although some women's POP can fix itself over time after incorporating exercise and high-fiber foods into their diets, Carolyn's doctor didn't believe her condition would resolve from lifestyle changes alone.
Carolyn's surgical options include having a sling made out of mesh inserted inside her to hold up her bladder and rectum and a hysterectomy to remove her uterus. For the time being, Carolyn said he gave her a pessary, a removable plastic ring that is placed into the vagina to support the uterus or bladder and rectum and help decrease urine leakage.
And while her husband wanted to be there for her at her doctor's appointment, Carolyn said she was too embarrassed - even after 10 years and two children together - to let him see her in this condition.
A week later, she met with her physical therapist, who assure Carolyn that she had helped many women with POP improve their condition. She also noted that she didn't want her patient to even 'say the word hysterectomy for at least six months'.
'And just like that, this woman I had never met before became my va-jay-jay coach,' she wrote.
Carolyn explained that during their sessions her physical therapist would insert her fingers into her vagina to see how she could control her pelvic floor while teaching her floor exercises to help tighten her core.
The mother-of-two, who was given approval from her doctor to have sex, tried to be intimate with her husband after her session, but found herself 'bone dry' and found 'sex unappealing' for the first time in their relationship.
Not only was her self-esteem 'shattered', but the next day she took out her pessary and found 'green discharge everywhere', revealing that she had developed an infection.
Because she felt like she was unable to control her own body, Carolyn threw herself into researching medical journals and studies about POP in the hopes of finding a way to treat her condition.
After she learned that overweight women have a great chance of developing pelvic floor disorders, she said she became 'unhealthily obsessed with food and exercise' and soon went from a size ten to a size four.
Carolyn said she tried to hide her depression from her family and friends, often cracking jokes about her condition, but on the inside she was starting to fall apart.
The mom said she 'hit rock bottom' the day her three-and-a-half-year-old daughter walked in on her while she was getting changed asked why her 'lady parts looked like they had a tongue'.
Carolyn recalled that when she started crying on the floor, her daughter told her: 'I never saw a grown-up cry before.'
She went on to use the moment as a learning opportunity for her daughter, telling her that people's imperfections are what make them unique.
And in her own way, her little girl understood, explaining to Carolyn that she wished she didn't have curly hair because all of the Disney princesses have straight hair.
'I realized that this precocious little human had given me what I needed most: empathy,' Carolyn said. 'She was not trying to fix me like my husband, make light of the situation like my friends, or tiptoe around the problem like my relatives. She was simply telling me she understood.'
Carolyn said that over the next six months it was her desire to be a good role model for her daughter that helped her overcome her feelings of embarrassment and despair over her situation.
Her core and pelvic muscles became stronger, and with the help of lubricant, she was able to have sex and achieve orgasms that were 'better and longer' than before thanks to her stronger pelvic muscles.
And while Carolyn said she still struggles and knows surgery is most likely still in her future, she doesn't let her condition control her anymore.
'When I look in the mirror, I no longer see a broken woman,' she said. 'When my husband says I look beautiful, I not only believe he means it, but I feel beautiful inside.'
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Women’s hidden epidemic: Pelvic organ prolapse
Feb 22, 2016 | Toledo Blade
Pelvic organ prolapse occurs when the natural support of the vagina is lost, resulting in “sagging” or herniation of the bladder, cervix, uterus, small bowel, or rectum, into the vagina. Your doctor may have also called this a cystocele, rectocele, or enterocele. When prolapse worsens, women can feel a bulge at the opening of the vagina. It is a very common problem. Approximately 50 percent of all women between the ages of 50 and 79 have some prolapse and approximately 300,000 surgeries for correction of pelvic organ prolapse are done in the United States each year.
Research has identified certain risk factors for pelvic organ prolapse. The genes we inherit from our parents can influence the strength of our muscles and tissues, so to some degree prolapse can be hereditary. We also know that Caucasian women are more likely than African American women to develop pelvic organ prolapse. Loss of pelvic support can also occur due to vaginal delivery or pelvic surgery. Some other conditions that increase the risk of prolapse include: aging, constipation and chronic straining, chronic coughing, repetitive heavy lifting, and obesity.
Prolapse is graded in Stages 1 to 4. Many women with mild to moderate prolapse do not have any bothersome symptoms. If prolapse progresses, most women complain of a vaginal bulge or a vaginal pressure that worsens with activity or prolonged standing. Other frequent symptoms include difficulty with urination, inability to empty the bladder normally, the need to push the bulge back in to urinate, and the need to place fingers in the vagina during bowel movements to evacuate stool.
There are several different types of prolapse. A cystocele is when the wall between the vagina and the bladder stretches or weakens. This allows the bladder to prolapse or fall down into the vagina and can cause bulge symptoms, issues with urination or even recurrent bladder infections. A rectocele occurs when there is weakening of the back wall of the vagina that allows the rectum to bulge into the vagina. This can also cause bulge symptoms or difficulty with bowel movements. Avoiding constipation (hard, infrequent stools) may prevent progression and also reduce symptoms from the rectocele. Uterine prolapse occurs when the cervix and uterus fall into and out of the vagina. This often occurs in combination with cystocele and/or rectocele and also produces symptoms of bulge and pressure.
Prolapse may be uncomfortable, but thankfully is not life-threatening and many treatment options are available. The treatment usually depends on how much a woman is bothered by her symptoms. Many conservative treatment options are available including weight loss, pelvic floor exercises, and pelvic floor physical therapy. One treatment for prolapse is a device inserted into the vagina called a pessary, which can be a very safe and effective non-surgical option.
If conservative therapies are unsuccessful, and symptoms are bothersome enough there are many surgical treatment options which are effective. Whether or not to have surgery for prolapse is an individual decision. Every woman's situation is different and there is no single operation that is right for every patient.
The goal of all reconstructive pelvic floor procedures is to restore normal pelvic floor anatomy and give the patient her best chance at maintaining a normal quality of life, including sexual intercourse if desired. Surgery is a major decision you must make with your physician. In addition to the experience and training of the surgeon, specific choices offered depend on the patient’s specific anatomy/vaginal defects, overall health, prior surgeries and current medical conditions, and the desire to retain sexual function.
Pelvic reconstructive surgery can be performed through an incision in the vagina, through a large incision made through the abdominal wall (open surgery), or through a series of small incisions in the abdomen through which the surgeon places a laparoscope and instruments (minimally invasive surgery). Repairs can be done with and without surgical mesh. There are unique advantages and disadvantages to each of these approaches.
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