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Online Sources

1. Covidien settles the score in more than 11,000 vaginal mesh cases

   Jun 25, 2015 | Fierce Medical Devices

   By Emily Wasserman
   
   
   ...But other companies including Johnson & Johnson ($JNJ), Boston Scientific ($BSX) and Bard are still wading through vaginal mesh claims. J&J and its Ethicon unit face more than 36,000 lawsuits in state and federal courts over related devices...
2. Help is available for women with bladder woes

   Jun 26, 2015 | Miami Herald

   By JULIE LANDRY LAVIOLETTE
   
   
   Some women shrug off incontinence, thinking the involuntary leaking of urine is just a normal part of aging. Others give up dancing, exercising or going to the movies because the leakage, coupled with a frequent or urgent need to go to the bathroom, is just too embarrassing.

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

Online Sources

1. Covidien settles the score in more than 11,000 vaginal mesh cases

   Jun 25, 2015 | Fierce Medical Devices

   By Emily Wasserman

   Medtronic's ($MDT) Covidien unit is settling more than 11,000 claims related to transvaginal mesh devices, months after a judge urged companies facing litigation over the products to resolve cases with plaintiffs rather than battling it out in court.

   As Reuters reports, the company did not reveal the amount of the settlement or how many cases would be resolved under the agreement with one of the plaintiffs' law firms. But there are about 11,300 filed and unfiled claims over Covidien's mesh products as of the beginning of this month, Medtronic said in a regulatory filing, and Covidien took a pre-tax charge of about $180 million in Q3 2014 related to litigation for mesh products, signaling a move by the company to put its mesh-related woes behind it.
   

   Still, Covidien is facing more legal drama for its vaginal mesh devices. Two of the company's subsidiaries supplied mesh products to another devicemaker, and Covidien is indemnifying that manufacturer in some of its cases, it said in its regulatory filing. And the company that received the mesh products should also indemnify Covidien in some cases for marketing the devices, it added.
   

   Covidien is staying mum on the name of the manufacturer mentioned in its filing. But C.R. Bard ($BCR) has revealed in its own regulatory filings that two Covidien units supplied it with mesh products and said Covidien was responsible for defending or indemnifying it in about half of the more than 14,000 claims it faces, Reuters reports. Bard, Covidien and a lawyer for the settling plaintiffs did not immediately return the new outlet's requests for comment.
   

   Covidien's move to settle litigation comes months after a federal district court judge overseeing a group of consolidated vaginal mesh cases urged companies to resolve cases instead of fighting claims in court. In December, Bard asked Judge Joseph Goodwin of the U.S. District Court for Southern West Virginia to delay its product liability trial over vaginal mesh devices. Goodwin shot down the company's request, saying he could not "imagine a corporation facing potentially billions of dollars in verdicts wouldn't find it advisable to try to achieve a settlement for a much lesser sum."
   

   Some devicemakers such as Coloplast and Endo ($ENDP) have decided to lay mesh-related claims to rest. In March 2014, Coloplast said it would pay $16 million to settle lawsuits over vaginal-mesh inserts, spurring talk of a global settlement. Endo followed suit and said in October that it would add $400 million to its $1.2 billion reserve to resolve "substantially all" claims related to vaginal mesh implants sold by its American Medical Systems subsidiary.
   

   But other companies including Johnson & Johnson ($JNJ), Boston Scientific ($BSX) and Bard are still wading through vaginal mesh claims. J&J and its Ethicon unit face more than 36,000 lawsuits in state and federal courts over related devices. Boston Scientific is dealing with more than 23,000 claims related to vaginal mesh implants in U.S. state in federal courts, including cases consolidated before U.S. District Judge Goodwin.
   

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2. Help is available for women with bladder woes

   Jun 26, 2015 | Miami Herald

   By JULIE LANDRY LAVIOLETTE

   Some women shrug off incontinence, thinking the involuntary leaking of urine is just a normal part of aging. Others give up dancing, exercising or going to the movies because the leakage, coupled with a frequent or urgent need to go to the bathroom, is just too embarrassing.

   But help is available to improve symptoms and get you back to doing what you love, medical experts say.

   “Often women delay getting treatment, because of embarrassment or they are afraid nothing will help,” said Dr. Rafael Perez, gynecologic surgeon and medical director of the Fibroid Center at South Miami Hospital’s Center for Women & Infants. “While it lengthens the time you have to deal with it, the good news is that most times, delaying treatment doesn't worsen the problem.”

   There are two main types of incontinence. Stress incontinence is when you leak urine, often when you cough, laugh, jump or run. Urge incontinence is more about increased frequency and urgency.

   Perez said he sees urge incontinence more in younger patients, while stress incontinence increases as you get older. “After menopause — the average age of menopause in the United States is 52 — over 50 percent of women have some sort of incontinence or bladder problem,’’ he said. “It's a humongous problem.’’

   So what's normal? If you're going to the bathroom more than seven times a day, that may be a problem, Perez said. But it needs to be examined with a full workup, family history, physical examination, assessment of symptoms, and a diary of how much fluid you take in, and how much you're peeing out.STRESS INCONTINENCE

   Therapy to help strengthen the pelvic floor is the first line of defense. This includes Kegel exercises (contracting the muscles that stop urine flow), biofeedback to help make sure you're doing the exercises right, and electrical stimulation, which contracts the muscles and helps strengthen the pelvic floor. “What that does is help the patient have a lot more control, and if the pelvic floor gets strong enough, they may not need anything else,” Perez said.

   Dr. Eric Hurtado, a gynecologic surgeon at Cleveland Clinic in Weston, said if pelvic floor therapy doesn’t help, there are other options. One is a pessary, a ring inserted in the vagina that puts pressure on the urethra to prevent leakage. “It’s another route for people who want to avoid surgery,’’ he said.

   Bulking agents, little beads injected around the urethra, also can help stop leakage. “They're very simple and they can be done in the office, but they're not the most effective treatment,’’ Hurtado said. Cleveland Clinic is involved in a research study that is using stem cells as an alternative to beads as a bulking agent, he said.

   The most common surgical option for stress incontinence is the mid-urethral sling, a mesh sling that supports a sagging urethra.

   “Urethral slings have become the go-to because of their ease, high success and low complication rates and because it is an out-patient surgery,” Hurtado said.URGE INCONTINENCE

   “We start with behavioral therapy and pelvic floor therapy, to see if they can get better,” said Dr. Yvonne Koch, a urologist at Mount Sinai Medical Center in Miami Beach. “We try lifestyle changes like avoiding bladder irritants like caffeine or alcohol.”

   Bladder retraining, systematically trying to lengthen the time a patient waits before they go to the bathroom, also can help, Perez said.

   The next step is oral medication for an overactive bladder. There are seven medications on the market. “The goal is to find something that works, is affordable, and has the fewest side effects,” Koch said.

   If the medicine doesn't work or the side effects are too severe, there are other treatments. Botox injections can help relax the bladder. InsterStim, or sacral neuromodulation, acts like a pacemaker for the bladder to change its impulses.

   Perez said one therapy, percutaneous tibial nerve stimulation, stimulates a nerve near the ankle that affects your bladder. The idea is to help reset the reflex to go, he said.

   Hurtado said acupuncture may help in about 50 percent of cases, but there is not enough good research to say for sure.

   Hormone cream such as vaginal estrogen cream may help post-menopausal women, he said. “If they have a lot of vaginal atrophy, it can help, along with the oral medication,” Hurtado said.

   The overall improvement rate with treatment is about 90 percent, he said. For a complete cure, where you don't leak a drop, it's about 50 to 60 percent.

   “Women think they're alone. They don't realize it's such a common problem,” Koch said. “Treatment improves quality of life, because when they get better, they go back to things they like to do.”

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