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Ethicon 06/09
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Ethicon's Own Rep. Said Mesh Degrades In Body, Patients Say
Jun 8, 2016 | Law 360
By Emily Field
Patients with injury claims against Johnson & Johnson's Ethicon over pelvic mesh repair systems on Wednesday told the West Virginia federal judge overseeing multidistrict litigation that the company’s own witness has testified numerous times that its device does indeed degrade inside the body. -
Endo 'reviewing options' for its incontinence device due to closure of its women's health unit
Jun 8, 2016 | Fierce Medical Devices
By Varun Saxena
Endo ($ENDP) is pulling out of the vaginal mesh business due to billions of dollars of litigation costs associated with the (often hazardous) devices for pelvic organ prolapse and urinary incontinence -
Bill aims to crack down on dangerous medical devices
Jun 8, 2016 | Democrat & Chronicle
By Brian Tumulty
Frank Interlichia of Rochester joined other patient advocates Wednesday to celebrate the introduction of House legislation they hope will lead to swifter action by the Food and Drug Administration to take dangerous medical devices off the market. -
Get Help for Incontinence
Jun 8, 2016 | Consumer Reports
By Lauren Cooper
Some treatments work. Others can worsen the problem. Many people hesitate talking about bladder-control problems. But they shouldn't. Incontinence is surprisingly common, affecting more than half of women and 30 percent of men ages 65 and older, according to the Centers for Disease Control and Prevention.
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Ethicon's Own Rep. Said Mesh Degrades In Body, Patients Say
Jun 8, 2016 | Law 360
By Emily Field
Patients with injury claims against Johnson & Johnson's Ethicon over pelvic mesh repair systems on Wednesday told the West Virginia federal judge overseeing multidistrict litigation that the company’s own witness has testified numerous times that its device does indeed degrade inside the body.
The patients are seeking to exclude the testimony of an expert witness for Ethicon, polymer scientist Dr. Stephen McClean, which they say is inconsistent with prior, "damaging" testimony given by one of Ethicon’s corporate representatives, Dr. Thomas Barbolt. In their filing, they say Dr. Barbolt has admitted that the surface layer of Ethicon's Prolene mesh devices can crack and that the company knew this several years before spreading misinformation to doctors through labeling that claimed that the devices didn’t degrade.
“Nevertheless, the defendants hired Dr. MacLean in an effort to undo this damaging testimony and, not surprisingly, Dr. MacLean’s opinions contradict Dr. Barbolt’s testimony,” the patients said.
Therefore, according to the plaintiffs, Ethicon’s argument that Dr. Barbolt’s testimony rebuts their assertion that the mesh devices degrade is not only “unbelievable,” but “borderline frivolous," and the company and its parent are bound by the admissions of their corporate designee.
There are about 23,000 suits against Ethicon and J&J in the MDL, which covers allegations that its mishandling of transvaginal surgical mesh devices caused serious injuries to patients. The cases also claim Ethicon and related entities failed to provide appropriate warnings and instructions regarding the risks and dangers posed by the devices, which are used to treat pelvic organ prolapse and stress urinary incontinence.
Seven separate MDLs comprising 70,000 cases are pending in West Virginia over the allegedly defective products. The U.S. Food and Drug Administration recently reclassified pelvic mesh devices like those at issue in the suits as high-risk devices that must undergo the agency's most stringent safety evaluation before hitting the market.
The Fourth Circuit in April affirmed a lower court's ruling that a case thrown out of another MDL over pelvic mesh devices was barred by a two-year statute of limitations, finding that the woman should have begun questioning the mesh's effectiveness by at least the end of 2007.
The three-judge panel said in an unpublished opinion that plaintiff Brenda L. Robinson's claims, as well as her husband's derivative claims, came too long after the expiration of Utah's two-year statute of limitations for product liability actions. Robinson's case was cut from the MDL afterBoston Scientific Corp., which made the mesh, won summary judgment last year.
Representatives for the parties in the Ethicon MDL didn’t immediately respond to requests for comment Wednesday.
The patients are represented by Bryan F. Aylstock and Renee Baggett of Aylstock Witkin Kreis & Overholtz PLLC and others.
Ethicon is represented by David B. Thomas of Thomas Combs & Spann PLLC.
The case is In re: Ethicon Inc. Pelvic Repair System Products Liability Litigation, case number2:12-md-02327, in the U.S. District Court for the Southern District of West Virginia.http://www.law360.com/articles/805047/ethicon-s-own-rep-said-mesh-degrades-in-body-patients-say
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Endo 'reviewing options' for its incontinence device due to closure of its women's health unit
Jun 8, 2016 | Fierce Medical Devices
By Varun Saxena
Endo ($ENDP) is pulling out of the vaginal mesh business due to billions of dollars of litigation costs associated with the (often hazardous) devices for pelvic organ prolapse and urinary incontinence. But the company has said that its investigational mesh-based Topas device to treat fecal incontinence among women "does not require transvaginal incision, or any incision or modifications to the pelvic floor muscle, and thus has a different safety profile than transvaginal mesh device." As a result, it could represent a viable financial opportunity. In light of the pending closure of Astora Women's Health, Endo is reviewing its best options for the "valuable" device, and has notified FDA accordingly, a company spokeswoman told FierceMedicalDevices. The agency's review process is continuing. In spite of the inevitable comparisons to vaginal mesh, the FDA's Gastroenterology-Urology Devices Panel unanimously voted that the device is safe and effective, making approval likely. It seems like a company that it is committed to devices will have the opportunity to commercialize the Topas, assuming it is willing to pay Endo an appropriate sum for the rights to the development program and technology. More about the Topas | Prior coverage of the closure of Astora
http://www.fiercemedicaldevices.com/story/endo-reviewing-options-its-incontinence-device-due-closure-its-womens-healt/2016-03-08
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Bill aims to crack down on dangerous medical devices
Jun 8, 2016 | Democrat & Chronicle
By Brian Tumulty
Frank Interlichia of Rochester joined other patient advocates Wednesday to celebrate the introduction of House legislation they hope will lead to swifter action by the Food and Drug Administration to take dangerous medical devices off the market.
The two bipartisan bills would make it easier for patients victimized by faulty devices to sue the manufacturers. They also would require physicians to tell the FDA about any problems the devices cause for patients.
Under current law, only hospitals and manufacturers are required to relay such information to the FDA, which patient advocates say leads to serious under-reporting. Physicians already are required to tell the FDA about adverse effects of prescription drugs, using an online database.
Democratic Rep. Louise Slaughter of Fairport and Republican Rep. Michal Fitzpatrick of Pennsylvania teamed up to introduce the legislation because each was approached by constituents with compelling stories about how a device used for minimally invasive hysterectomies caused an otherwise treatable cancer to spread.
“What should been a routine procedure has ended with a death sentence,’’ Slaughter said Wednesday, noting that Interlichia is one of three local men whose wives died as a result of the procedure. Slaughter has asked the Government Accountability Office to investigate why the FDA approved the device in question, known as a power morcellator. It dices up the uterus and fibroids, which in some cases can host malignant cancers.
“All of us share a similar sad story,’’ Interlichia said as he looked over a group of about two-dozen patient advocates who traveled from as far away as California for the announcement.
He said his late wife’s fervent wish was "to make sure this never happens to anyone else.’’
Fitzpatrick was approached by husband-and-wife physicians, Hooman Noorchashm and Amy Reed, after use of a power morcellator during Reed’s hysterectomy caused her undetected cancer to spread. The couple were the first people to file an official complaint with the FDA in November 2013.
“While we all agree that the majority of medical devices can and should prove to be invaluable, life-saving products,’’ Fitzpatrick said, “we must also note some well-intentioned products can cause harm and have devastating consequences on patient safety and patient health.’’
Dr. Amy Reed discusses how her cancer spread as a result of the use of a power morcellator. She was accompanied by her husband, Dr. Hooman Noorchashm at the news conference outside the U.S. Capitol on Wednesday, June 8. (Photo: Brian Tumulty, USA TODAY)
Reed said physicians at the Boston hospital where her hysterectomy was performed failed to report the problem, even though another patient there was dying from a similar complication at the same time she had her surgery.
“In medical school they tell you all the time, if a patient has an adverse reaction to a drug, you need to report it,’’ Reed said in an interview. “They never say anything about device reporting. My hope is that there is a trickle-down effect now if it’s made into law, (that) it becomes part of the American Medical Association’s educational curriculum and that medical students think about medical devices the same way they think about drugs.’’
The legislation also could address widely reported problems with other medical devices, including a pelvic mesh, a redesigned blood clot filter and the permanent contraceptive known as Essure.
The online group known as the “Essure problems’’ group has 29,800 members, an advocate for the group said.
“When a medical device is not safe, we should have an efficient system to monitor and to remove it from the market,’’ said Fitzpatrick. “And those harmed should have legal recourse through the judicial system. And, unfortunately, today for some, that is just not the case.”
The two bills have no Senate sponsors as yet, but Fitzpatrick expressed optimism the legislation will be considered by the end of the year.
http://www.democratandchronicle.com/story/news/2016/06/08/bill-aims-crack-down-dangerous-medical-devices/85626112/
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Jun 8, 2016 | Consumer Reports
By Lauren Cooper
Many people hesitate talking about bladder-control problems. But they shouldn't. Incontinence is surprisingly common, affecting more than half of women and 30 percent of men ages 65 and older, according to the Centers for Disease Control and Prevention.
If you leak unexpectedly or sometimes have such a strong urge to urinate that you fear you won’t make it to a bathroom in time, you could use products such as absorbent pads or underwear. Or you might be considering a drug or procedure you’ve seen advertised.
But what works best? Our experts weigh in.Start With Your Doctor
If you feel uncomfortable talking about the problem, consider that your primary care doctor has probably discussed it with many patients. (If he or she hasn’t treated bladder conditions, see a doctor who has, such as a gynecologist, urologist, or urogynecologist.) “A doctor can determine if a medication side effect or a condition like diabetes or a urinary-tract infection might be causing urine leakage,” says Consumer Reports’ chief medical adviser, Marvin M. Lipman, M.D. Try Non-Drug Therapy
Exercises or bladder training should be the first treatment tried, says the American College of Physicians.Kegel exercises (repeatedly tightening and relaxing the muscles that stop urine flow to strengthen them) are especially helpful for women with stress urinary incontinence, or leaking when they laugh, cough, sneeze, lift heavy objects, or exercise. Bladder training involves keeping a diary of urination and accidents, then slowly increasing the time between bathroom visits. It’s most effective for men and women with urge incontinence, a sudden, urgent need to urinate. Kegels haven’t been proved to be effective for men, but experts say trying them is reasonable. Women with both types of incontinence can try bladder training and Kegels.
Both strategies can help. A small study recently published in the journal Menopause found that a 12-week course of physical therapy, which included Kegels and bladder training, resulted in a 75 percent reduction in the number of leakage episodes, an improvement that was still evident a year later. Study subjects who didn’t do the physical therapy techniques saw no improvement, and a year later their incontinence had worsened. Using the correct muscles to do Kegel exercises is key to success, so don’t hesitate to ask your doctor for advice. And be patient; it can take several weeks to see a benefit. Know Drug Pros and Cons
Several drugs are approved for urge incontinence (or overactive bladder), such as prescription mirabegron (Myrbetriq), oxybutynin (Ditropan XL and generic), solifenacin (Vesicare), and tolterodine (Detrol and generic). The little evidence available suggests they might work as well as non-drug therapy. But according to our Best Buy Drugs experts, more than half of those who take incontinence drugs stop within six months because of side effects including constipation, drowsiness, dry mouth, blurry vision, and dizziness. Botulinum toxin type A (Botox) injections into the bladder muscle are also approved for this condition and may reduce the urge to urinate. But they have been associated with urinary-tract infections and incomplete bladder emptying requiring catheterization.
“Medications should only be considered for those who continue to have bothersome symptoms despite having tried lifestyle changes and therapy exercises,” says Michael Hochman, M.D., M.P.H., an assistant professor of clinical medicine at USC’s Keck School of Medicine. Think Twice About Surgery
Several surgical procedures are available for stress incontinence. The most common is midurethral-sling surgery, where strips of synthetic mesh are implanted to support the urethra. It can be effective. In a study of several hundred women published in the New England Journal of Medicine in 2013, 85 percent of those who had the surgery said they no longer leaked. Only 53 percent of those who did physical therapy alone got relief after a year.
But the surgery carries risks including infection, difficulty urinating, and an increase in the severity of incontinence. “Surgery should only be considered as a last resort,” Lipman says.
http://www.consumerreports.org/conditions-treatments/help-for-urinary-incontinence/
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