Preview Newsletter
ethicon 7/17
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Norfolk women back campaign raising concerns over safety of operation
Jul 15, 2015 | Eastern Daily Press
By Kath Sansom
A Norfolk mother and daughter have backed a campaign for an operation carried out on women to be suspended after they both suffered painful problems after having the treatment. -
Pelvic Mesh Trials Naming J&J
Jul 16, 2015 | Mesh Medical Device News Desk
By Jane Akre
The following is a partial list of the upcoming pelvic mesh trials naming J&J’s Ethicon mesh as defective. Understand that the schedule frequently changes so this is the most up-to-date -
What women should know about gynecologic conditions
Jul 16, 2015 | San Diego Union-Tribune
By Dr. Craig Saffer
Many women live with gynecologic conditions like fibroids, endometriosis, urinary incontinence or pelvic prolapse, without seeking treatment. There are many reasons for this. -
Incontinence strikes young adults
Jul 17, 2015 | The Times of India
By Umesh Isalkar
...Patients with mild and early stage of incontinence are treated with medicines and Kegel exercises. In severe cases, surgical procedures like sling, tension free vaginal tape are conducted in women...
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Norfolk women back campaign raising concerns over safety of operation
Jul 15, 2015 | Eastern Daily Press
By Kath Sansom
A Norfolk mother and daughter have backed a campaign for an operation carried out on women to be suspended after they both suffered painful problems after having the treatment.
The operation, carried out in the region’s hospitals, uses a device known as a TVT mesh sling to cure incontinence or pelvic organ prolapse, a problem that can often be caused by natural childbirth, especially if women have had big babies.
However, there have long been concerns about complications caused by the procedure and last month a campaign called Sling The Mesh, was launched calling for the procedure to be suspended and reviewed for safety.
Kate Wood, a 36-year-old from King’s Lynn, had a TVT inserted in April 2012 and has since had three operations carried out by the same surgeon to try to correct it.
This weekend she travelled to London to have her fourth operation by one of two leading surgeon’s in England who can successfully remove mesh.
The mother-of-two said: “I want to get the word out there that this does not always work out. It can have devastating consequences.
“I was made to feel like I was the only woman suffering but since finding Sling The Mesh I realise it is not just me.
“It has been a nightmare. In 2014 I went to my GP and said this is ridiculous I need help. I can’t run or exercise because it hurts too much. It is beyond frustrating, I used to do fun stuff with my kids and now I can’t.”
In 2010 her mum Elizabeth Barrett, 56, also had the operation done and has suffered with pain. Mrs Barrett is also going to go and See Ms Elneil about possibly having her TVT mesh out.
The campaign was launched by Kath Sansom, an Archant journalist from March, in Cambridgeshire, who has suffered since having the operation four months ago.
Around 40pc of women have the problem after natural childbirth which weakens pelvic floor muscles.
Within a month of launch more than 600 people have joined her Facebook support group with problems of leg pain, hip pain, groin pain and difficulty going to the toilet.
She said some are in wheelchairs or struggle to walk far due to nerve damage or the mesh pressing on nerves.
To find out more about the campaign, visit Kath’s blog at slingthemesh.wordpress.com.
If you have undergone the operation and want to tell your story, contact Kath on 01354 652621 or email kath.sansom@archant.co.uk
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Jul 16, 2015 | Mesh Medical Device News Desk
By Jane Akre
The following is a partial list of the upcoming pelvic mesh trials naming J&J’s Ethicon mesh as defective. Understand that the schedule frequently changes so this is the most up-to-date. Other manufacturers cases will be added as they become available.
Trial updates
The Jennifer Ramirez v. Ethicon case was supposed to start July 13 in San Antonio, Texas before Judge J. David Canales. (case #2012-ci-18690), 73rd Civil Division, Tx.
However, J&J/Ethicon removed the case to federal court in June. Edwards de la Cerda law firm filed their remand papers the next day, but the local district court (Western District of Texas) punted the decision to the Southern District of West Virginia. At the present time there’s been no decision from the Southern District of West Virginia as to whether this case will go back to San Antonio. A decision could come soon.August 24, 2015 – Tonya Edwards v. Ethicon 2:12-cv-09972, Charleston, WV before Judge Joseph Goodwin. The device in question is the TVT-O. Edwards was implanted at Piedmont Healthcare, Atlanta GA by Dr. Harold Wittcoff. Counts include Negligence, Strict Liability-Manufacturing Defect; Failure to Warn; Defective Product; Design defect; Fraud and fraudulent concealment, Negligence, Breach of express warranty, violation of consumer protection laws, gross negligence, unjust enrichment, loss of consortium and punitive damages.
Attorneys are Mark Mueller, John Fabry, Breanne Vandermeer. The case was filed December 31, 2012. This trial is limited to six days writes Judge Goodwin in a June 12, 2015 order.
September 21, 2015 – Carol Cavness v. Ethicon , She was implanted with the Gynecare Prosima Pelvic Floor Repair System, April 24, 2012. DC-14-04220, 95th Judicial District Court before Judge Ken Molberg, Dallas. Attorneys are Blankenship Law and Freese and Goss. See here.
The case was filed in April 21, 2014 against Ethicon and Teresa Kowalczyk MD, a doctor at Hunt Memorial Hospital, Baylor Healthcare system. Cavness had a partial explant and suffers pain discomfort, difficulty voiding, continued incontinence, infection, bleeding. Included in the multiple finings here is a Motion to exclude the testimony of Michael Thomas Margolis MD as an expert witness. This documents goes on for 63 pages about other experts suggested to appear in this case.
See:
http://courts.dallascounty.org/ViewDocumentFragment.aspx?DocumentFragmentID=11874341
http://courts.dallascounty.org/CaseDetail.aspx?CaseID=4895375
October 26, 2015 – Josephine Marie Rabiola v. Ethicon, 53rd Judicial District Court, Travis County, Austin TX. She was implanted with both the TVT-Secur System and the Gynecare Prosima Pelvic Floor System (for pelvic organ prolapse). Dr. Tomas G. Antonini and Lone Star Urogynecology and Continence Center are defendants in this action. She was implanted by Dr. Chris Hart, MD on May 24, 2010 at Seton Southwest Hospital in Austin, Tx. Case #D-1-GN-13-002039. (DC-14-04220). The case could take up to three weeks. This jurisdiction is not available online but here is the Rabiola Complaint.December 7, 2015 – Mullins et al v Ethicon 2:12-cv-09311 (previous case Bryant et al v. Ethicon), 2:12-cv-02952, 2:12-md-12327, jury selection Dec. 4, 2015 at 8:30.
Thirty-seven plaintiffs will have their case consolidated before Judge Goodwin. All of the plaintiffs have been implanted in West Virginia and have the Ethicon TVT. Dr. Eddie H.M. Sze implanted TVT in more than half of the West Virginia plaintiffs. This will be a strict liability defective design and negligence claims. Still debated is whether it will include causation that plaintiffs say will allow them to make their case. According to a filing, Doc #28, “The question of whether a product is defective is inextricable intertwined with the issues of causation and damages.”
According to Judge Goodwin in PTO #184, filed July 1, 2015, the cases are consolidated on the issue of design defect and all have a common question of law or fact.
“Among these cases, the claims against Ethicon are the same: negligence, design defect, defective product, manufacturing defect, failure to warn, breach of express warranty, breach of implied warranty, and punitive damages.”
In Doc #32 Plaintiffs Plaintiffs’ Response to Def Objections to PTO# 182
Defendants object to consolidated trial and argue that it will lack the required finding that a defect existed in an individual device, which caused her injuries. Defendant (Ethicon) argues that a consolidated trial would feature a composite plaintiff who would suffer every possible injury. The company argues that a determination of defect liability would violate their constitutional rights under the Fifth Amendment due process clause and the Seventh Amendment’s reexamination clause. They call the consolidation a “logistical nightmare”.
Plaintiffs say a consolidated trial that includes evidence on complete design defect and negligent design claims including causation and damages would alleviate the concerns. Under West Virginia law there is no requirement to prove there was a safer alternative design. Plaintiffs want a trial on Plaintiffs’ complete claims for design defect and negligent design, including causation and damage issues. Stay tuned. #
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What women should know about gynecologic conditions
Jul 16, 2015 | San Diego Union-Tribune
By Dr. Craig Saffer
Many women live with gynecologic conditions like fibroids, endometriosis, urinary incontinence or pelvic prolapse, without seeking treatment. There are many reasons for this.
Some women are hesitant to discuss their symptoms with a doctor because they find them embarrassing or they assume their experience is just a normal part of aging.
This is especially true when it comes to female pelvic floor disorders which include incontinence, chronic pain, and prolapse. These disorders occur due to a weakening of the pelvic muscles and are more common as women age. In fact, an estimated 40 percent of all women will experience some form of pelvic disorder throughout their lifetime. However, it is important to know these disorders don’t have to be a part of aging, and they can improve with treatments like medications, physical therapy and minimally invasive surgery.
The prospect of surgery can be daunting — from taking time away from work and family, to concerns about pain and recovery time. The good news is that gynecologic conditions can often be managed or treated without surgery.
When surgery is required, the latest minimally invasive techniques are designed to reduce pain, scarring, and recovery time:
Hysteroscopy
During hysteroscopy, a doctor inserts a hysteroscope— a thin instrument with a lens, light source and camera attached to one end — through the vagina and cervix to examine the uterus. This technique is often used in diagnosis (biopsy of the uterus to check for cancerous growths) or to treat an underlying problem such as the removal of small polyps or fibroids. Hysteroscopy can also be used for tubal sterilization.
Laparoscopy
A laparoscope consists of a long lens with a small video camera attached to it. The laparoscope is most often inserted through the belly button, easily hiding the incision site. Two to three additional small incisions may be used for insertion of other instruments. Laparoscopic techniques can be used to diagnose and evaluate pelvic disorders, perform minimally invasive hysterectomies or tubal sterilization, or treat endometriosis.
Robotic surgery
Robotic surgery uses state-of-the-art technology that allows the surgeon’s hand movements to translate into extremely precise movements to perform complex procedures through small incisions. Robotic surgery has proven to be effective for minimally invasive hysterectomies, as well as the treatment of fibroids, prolapse and gynecologic cancer.
Vaginal-approach surgeries
Vaginal-approach surgeries allow for surgical intervention without incisions in the abdomen by performing the procedure directly through the vagina. Procedures such as hysterectomies, pelvic floor reconstruction and prolapse surgeries can be performed in this way.
Talk to your doctor
If you are experiencing problematic or painful gynecologic symptoms, it is important to have an open and honest discussion with your doctor. There are often treatments available that can reduce or eliminate your symptoms and allow you to get back to the activities you enjoy.
Craig Saffer, MD, is a board-certified specialist in obstetrics and gynecology who is Director of Minimally Invasive Surgery at Sharp Mary Birch Hospital for Women & Newborns. He has received Center of Excellence in Minimally Invasive Gynecology (COEMIG) designation by the American Academy of Gyneco
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Incontinence strikes young adults
Jul 17, 2015 | The Times of India
By Umesh Isalkar
Twenty-eight-year-old Sheetal gets at least a dozen bladder contractions a day. Even a small amount of urine can give her contractions, and going to the washroom doesn't always help.
Overactive bladder (OAB) is a condition where patients experience urgent sensation to pass urine, frequent urination, and may leak urine before they are able to reach the washroom. These symptoms may appear singly or in combination, in the absence of identifiable causes such as bladder infections or tumours. Overactive bladder is also known as urge incontinence and is actually a form of urinary incontinence or an unintentional loss of urine.
Urinary incontinence is often considered a problem of middle and old age. But childbirth, injuries and medical conditions can lead to bladder control issues in young adults, too.
"The prevalence of OAB is similar in women and men. However, the prevalence of incontinence associated with OAB is higher in women as compared to men. The prevalence of OAB increases with age and in women it increases with body mass index (BMI). Its prevalence in young women is 20 per 1,000 female population. Frequent urinary tract infections, obesity, smoking and diabetes can also cause urinary incontinence at a young age," said consultant urologist R K Shimpi of the Ruby Hall Clinic.
Shimpi said, "Women who urinate eight or more times a day or more than two times at night with or without urine leakage are part of this group. Many affected by this disorder never get the help they need. They are either embarrassed, hold an incorrect assumption that it is a natural part of aging, or just hope the problem will go away on its own. However, there are effective treatment options available."
"Experiencing frequent urination problems and having an overactive bladder can be very difficult to deal with, and is embarrassing for many. Overactive bladder can wreak havoc by disrupting work, sleep and social outings," said consultant urologist Shirish Yande of Ratna Memorial hospital.
Yande said, "Many women who suffer from bladder control problems often feel embarrassed and alone. Some women even shy away from daily activities including exercise, socialising and even sexual activity. Women need to know that there are many promising drugs and treatment options available to help them regain control over their bladder and their lives."
Symptoms of overactive bladder can include, aside from urgency in urination, increased frequency in urination that is usually eight or more times in 24 hours, urge incontinence which is the involuntary leakage of urine immediately following an urgent need to urinate and needing to wake up two or more times in the night to urinate (nocturia).
"Though, discussing the problem may be difficult because it is considered by many as a very private issue, it is very important that a doctor is consulted. This is especially true if there is urge incontinence or if the other symptoms of overactive bladder are beginning to cause disruption in social interactions, work schedules and daily activities," said Yande.
There are times when people consider bladder problems as something that is a normal part of aging and simply go about wearing adult diapers and pads. However the symptoms of overactive bladder are not an inevitable part of aging and there are treatment options available. Also, it is crucial to speak with a doctor because urge incontinence or an overactive bladder may be a result of a serious issue like a tumor that could be cancerous, he added.
There are some simple first steps people can make on their own. If these methods don't work, anti-muscarinics are mainstay of managing over active bladder symptoms besides many effective non-surgical and minimally invasive surgical treatment options that can offer significant and often dramatic relief from these symptoms. Some of the options include a new class of medication with far fewer side effects than prior medications, including pelvic floor rehabilitation and tibial nerve stimulation.
"Patients with mild and early stage of incontinence are treated with medicines and Kegel exercises. In severe cases, surgical procedures like sling, tension free vaginal tape are conducted in women. Those who have urinary leak following prostate cancer surgery or radiotherapy are treated with male sling or artificial sphincter. Artificial sphincter are used in patients with extremely severe form of incontinence," said senior reconstructive urosurgeon Sanjay Kulkarni, director of the Kulkarni Reconstructive Urology Centre — a tertiary referral centre.
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