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Ethicon 17/8

    Client Attorney Privileged/Attorney Work Product/At Request of Counsel

    Online Sources

  1. Aussie women prepare for class action over pelvic floor treatment

    Aug 16, 2015 | 9News

    A large group of Australian women are taking on a major US medical company after suffering devastating side-effects from products used to support weak pelvic floor muscles, with the products still available in Australia.
  2. Australian women to sue medical device manufacturer

    Aug 17, 2015 | Manufacturers' Monthly

    By Bret Balinski

    Hundreds of Australian women are reportedly preparing to sue American Medical Systems over the effects of a mesh-based product.
  3. Acupuncture Halts Urinary Incontinence

    Aug 15, 2015 | Health CMi

    Acupuncture helps women with stress urinary incontinence (SUI). This condition is characterized by leakage of urine during physical activity, standing, sexual intercourse, sneezing, or coughing.
  4. Why Routine Kegel Exercises Are A Must For All Women

    Aug 17, 2015 | Coastweek

    Routine Kegel exercises are a must for all women particularly of child bearing age throughout their lives. The exercises are named after Dr Arnold Kegel, the gynaecologist who first described them to strengthen the pelvic floor muscles.
  5. Mesh Trial Pioneer Linda Batiste to be Laid to Rest

    Aug 14, 2015 | Mesh Medical Device News Desk

    By Jane Akre

    A funeral is scheduled for Saturday, August 15 in Garland, Texas for mesh-injured pioneer Linda Elizabeth Batiste. Batiste died Saturday, August 8th. She had been suffering from cancer.

    Client Attorney Privileged/Attorney Work Product/At Request of Counsel

    Online Sources

  1. Aussie women prepare for class action over pelvic floor treatment

    Aug 16, 2015 | 9News

    A large group of Australian women are taking on a major US medical company after suffering devastating side-effects from products used to support weak pelvic floor muscles, with the products still available in Australia.

    Prolapse occurs when the connecting muscle and tissue which supports the bladder, uterus and bowel are weakened, causing organs to drop. It affects one in four Australian women.

    Patricia Stiles first suffered the traumatic but common condition after the birth of her third child more than 30 years ago.

    "Sometimes I'm in so much pain my legs swell, my hands swell, I can't even get out of bed with the pain," she said.

    Ms Stiles' prolapse was allegedly made worse by the very thing that was meant to fix it, a mesh product used to help lift the organs back in place.

    She is now one of hundreds of Australians preparing to sue medical manufacturer American Medical Systems (AMS).

    It is claimed the mesh - made of plastic called polypropylene - can perforate organs and erode tissue, causing severe pain, bleeding and infection.

    Two warnings were issued by the Food and Drugs Administration in the United States in 2008 and 2011.

    However the 64-year-old grandmother said she was never told there was any risk of using the mesh product.

    A class action in the US has seen 30,000 claims settled, with the company paying out almost US$1 billion.

    Australian legal firm Shine Lawyers has been working on more than 100 claims.

    AMS told 9NEWS it cannot comment on the Australian cases while there is ongoing litigation.


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  2. Australian women to sue medical device manufacturer

    Aug 17, 2015 | Manufacturers' Monthly

    By Bret Balinski

    Hundreds of Australian women are reportedly preparing to sue American Medical Systems over the effects of a mesh-based product.

    9News reports that over 100 claims, being examined by Shine Lawyers, detail the claimed effects of a polypropylene product designed to deal with prolapse.

    The implants were the subject of a US class action, which saw 30,000 claims settled and payouts amounting to nearly $US 1 billion.

    The product, which has been said to damage pelvic organs and lead to pain, bleeding and infection, is still sold locally.

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  3. Acupuncture Halts Urinary Incontinence

    Aug 15, 2015 | Health CMi

    Acupuncture helps women with stress urinary incontinence (SUI). This condition is characterized by leakage of urine during physical activity, standing, sexual intercourse, sneezing, or coughing. 

    Stress incontinence is due to pelvic floor muscle weakness leading to increased pressure on the bladder upon stress. Risk factors include pelvic surgery, hormonal deficiencies, and delayed second stage of labor. Forceps delivery may also be associated with this condition. The researchers discovered that a special acupuncture procedure produces a total effective rate of 93.3%.

    Standard care treatments include pelvic floor muscle exercises, retiming of fluid consumption, urethral inserts, injectable bulking agents, and several surgical procedures. In this study of 60 female patients with SUI, a control group practicing pelvic muscle floor exercises was compared with a treatment group receiving acupuncture combined with pelvic floor muscle exercises. The average symptom duration for all patients was between 9.7 and 10 years.

    The pelvic floor muscle exercises were practiced every day for 30 days. Acupuncture was applied to a series of acupoints known as Baliao, translated as eight crevices. This series of 4 points are individually known as Shang Liao (BL31), Ci Liao (BL32), Zhong Liao (BL33), and Xia Liao (BL34). The acupoints are located over the first through fourth sacral foramen.

    Deep needling was applied at angles between 30 and 45 degrees. Needle retention time was 20 minutes per session. Moxibustion was applied to warm the needles. Acupuncture treatments were applied 5 times per week for a total of 6 weeks. The control group had a total effective rate of 70% and the acupuncture treatment group had a total effective rate of 93.3%.

    The researchers note that use of the acupuncture point prescription used in the study is consistent with Traditional Chinese Medicine (TCM) theory. Many urinary disorders are related to kidney deficiency and qi deficiency. Baliao points are traditionally used to nourish kidney qi and regulate urination. Baliao points regulate the bladder and stimulate local muscles. As a result, the acupuncture point prescription is consistent with TCM principles of treatment. 

    It appears that the researchers are testing a protocol of care for SUI that is less invasive than surgical intervention. Currently, SUI may be treated with a sling procedure, retropubic colposuspension, or an inflatable artificial sphincter. The sling procedure is insertion of a mesh support system for the urethra. The support may be synthetic, the patient’s own tissue, donor tissue, or animal tissue. Retropubic colposuspension involves attachment of sutures to lift the bladder and upper urethra. The inflatable artificial sphincter is an implant but is more commonly used for men than women.

    Given the high efficacy rate of acupuncture combined with pelvic muscle floor exercises, it is a reasonable treatment option. Additional research on all of the SUI treatment options will help to determine a refined protocol. Larger sample size studies and long-term studies will help to identify methods to achieve maximum positive patient outcomes.

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  4. Why Routine Kegel Exercises Are A Must For All Women

    Aug 17, 2015 | Coastweek

    Routine Kegel exercises are a must for all women particularly of child bearing age throughout their lives. The exercises are named after Dr Arnold Kegel, the gynaecologist who first described them to strengthen the pelvic floor muscles.

    The pelvic floor in women supports the uterus, bladder and bowel and prevents a common condition known as pelvic organ prolapse affecting half the women who have had children.

    According to Dr Johnstone Miheso, Programme Director and Urogynaecologist in the Faculty of Health Sciences at the Aga Khan University Hospital, there are many ‘silent sufferers’ who are too embarrassed to seek medical help about some of the pelvic floor disorders yet the conditions can be prevented by practicing daily kegel exercises.

    Kegel exercise is a type of physiotherapy which consists of repeatedly contracting and relaxing the muscles that form the pelvic floor.

    The practice is similar to a lady pretending she has to urinate and then holding it.

    Pelvic organ prolapse is the descending, or drooping of any of the pelvic floor organs including the bladder, uterus, vagina and rectum into, or outside of the vaginal canal.

    Dr Miheso explains this as a common condition among women who have had vaginal delivery and attributes age (above 40), multiple deliveries and menopause as the main risk factors.

    Other causes are obesity, chronic constipation and cough and previous pelvic operations such as hysterectomy.

    Describing the symptoms Dr Miheso said, “Patients may present with a dysfunction of one of the organs either bladder, bowel or recurrent vaginal discharge and problems when having sexual intercourse.

    "They may also have urinary incontinence, or describe a feeling of a ‘bulge’ from beneath, or a sensation of ‘sitting’ on a ball.”

    “About 50 per cent of women do not show any symptoms and those who do are sometimes vague because of embarrassment.

    "A keen gynaecologist should therefore be able to identify this problem through a careful history, physical examination, or when conducting a pap smear test.”

    Regarding treatment, Dr Miheso said, “Prevention through kegel exercises is the best way of managing this condition.

    "However, when it occurs it can also be treated through surgery.

    "The operation is usually done from down below (vaginally). When the patient has recovered from the operation kegel exercises must resume.”

    “Patients can seek help in general hospitals and a majority do not need specialised treatment.

    "By reporting the condition early people can avoid social problems associated with pelvic organ prolapse.”

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  5. Mesh Trial Pioneer Linda Batiste to be Laid to Rest

    Aug 14, 2015 | Mesh Medical Device News Desk

    By Jane Akre

    A funeral is scheduled for Saturday, August 15 in Garland, Texas for mesh-injured  pioneer Linda Elizabeth Batiste.   Batiste died Saturday, August 8th. She had been suffering from cancer.

    Linda Batiste, 65, was the plaintiff in the first trial to win a jury award against Johnson & Johnson over her pelvic mesh implant, a TVT-O made by Ethicon, a division of J&J.

    Ms. Batiste was awarded $1.2 million by a Dallas jury on April 3, 2014. Enduring pain and walking with a cane, Ms. Batiste, a former registered nurse, attended nearly all of her three-week trial.

    In a precedent setting decision, the jurors decided the TVT-O was defectively designed. They rejected Batiste’s claim that Ethicon didn’t provide proper warnings about the health risks and declined awarding punitive damages.  Since her trial, the jury in the Jo Husky trial also decided the Ethicon TVT-O was defective in its design.

    The incontinence treatment remains on the market.

    See the story on the trials conclusion on Mesh News Desk here. See the trial coverage on Mesh News Desk here.    Aaron Horton covered the trial for Mesh News Desk along with another mesh injured woman who prefers to be called “Kathy.” See her coverage here.

    According to the family, Aaron is considered one of the family and fundraising efforts were approved by Sara Gaston, Linda’s oldest daughter, as well as the rest of the family.  Here is the Linda Batiste program for the Saturday service.

    The Mesh Warrior Foundation reports 100% of the proceeds from her page will go toward expenses to lay Ms. Batiste to rest. The purple and blue ribbons were made by Horton and Linda’s grandson, Josh, this week to be given out at the service.

    Linda’s favorite color was purple.

    “Thank you! It’s perfect,” Ms. Gaston wrote in approving the web post.

    The jury award of $1.2 million has never been paid by Johnson & Johnson and is on appeal.

    “Although she lost her battle for life; she died knowing that she had won the war,” says her obit.   #

    Please Note* There has been a change for Ms. Batiste’s services. They will still be held Saturday, August 15, 2015 with visitation from 10:00 am to 10:45 am. Her Celebration of Life Service will follow at approximately 12:00 Noon at: Macedonia Baptist Church 3925 Bucknell Dr. Garland, TX 75042

    Horton and The Mesh Warrior Foundation is dedicated to raising funds for Ms. Batiste’s family. All of the proceeds from this page will go towards the expenses necessary to lay Ms. Batiste to rest, including a headstone, all done with the family’s approval and blessing.  Here is the link to donate.

    Aaron Horton’s story on Linda Batiste appears on The Mesh Warrior blog.  

    Here is the Chamberland Funeral Home notice.   

    Mesh News Desk offers its sincerest condolences to the family of Linda Batiste.  May she rest in peace.  #

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