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CR Bard Gets Mesh Implant Suit Trimmed
Jun 4, 2015 | Law360
By Jody Godoy
Medical device maker C.R. Bard Inc. and its subsidiary Devol Inc. shook eight of nine claims brought by a man who says that the companies' mesh implant has left him with chronic pain, in a ruling in Pennsylvania federal court on Thursday. -
Robot-assisted surgery for pelvic organ prolapse
Jun 4, 2015 | 7 KPLC
By Britney Glaser
Whether it is having a baby, aging, undergoing a hysterectomy or gaining weight, many women will develop a condition where their pelvic floor organs begin to fall or prolapse. That can impact more than the quality of life. Left untreated, you could develop a host of medical complications. -
Advantage Therapy in Eveleth now offers pelvic floor rehabilitation
Jun 5, 2015 | Hometown Focus
Advantage Therapy in Eveleth offers therapy specifically related to women’s health issues and, together with the Fitzgerald Nursing Home and Rehab, Advantage Therapy has purchased computer software called Telesis.
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CR Bard Gets Mesh Implant Suit Trimmed
Jun 4, 2015 | Law360
By Jody Godoy
Medical device maker C.R. Bard Inc. and its subsidiary Devol Inc. shook eight of nine claims brought by a man who says that the companies' mesh implant has left him with chronic pain, in a ruling in Pennsylvania federal court on Thursday.
Judge Stewart Dalzell granted the companies' motion to dismiss most claims brought by Joseph Runner in his suit over the companies Bard Composix L/P Mesh product but preserved the plaintiff's negligence claims.
Runner says in his complaint that he had the device implanted during a 2012 surgery and that the implant, which is used to reinforce the abdominal muscles in hernia patients, now causes him chronic pain.
In September, the plaintiff sued C.R. Bard and its subsidiary, which jointly manufacture and distribute the mesh product. He tried to have the claim moved to a multidistrict litigation over the product in Rhode Island federal court, but the attempt was denied because the panel was not accepting new cases. The defendants moved to dismiss in December.
Judge Dalzell agreed with the defendants on eight out of nine of Runner's claims. However, the judge said that Runner had sufficiently pled negligence, and kept alive his allegations that the companies committed negligence in manufacturing and designing the product and by failing to warn his doctor of the alleged dangers of the product.
The judge axed the plaintiff's strict liability claims for design and manufacturing defects and failure to warn as well as his breach of implied warranty claim because Pennsylvania has adopted tort law that classifies prescription drugs as unavoidably unsafe but not unreasonably dangerous.
The federal court noted that although the Pennsylvania Supreme Court has not ruled on whether the law, contained in the Restatement (Second) of Torts and known as “comment k,” extends to medical devices, the Superior Court has issued a decision to that effect.
The judge said that Pennsylvania law also bars Runner's misrepresentation and fraudulent concealment claims because he did not adequately distinguish them from a negligence for failure to warn claim.
Judge Dalzell tossed Runner's breach of express warranty claim because he had failed to pinpoint to the device maker statements on which he relied.
On Runner's claim of emotional disturbance, the court ruled that he did not establish that the companies had a duty to care for his well-being or alleged a specific physical injury, the two applicable criteria under state law.
C.R. Bard is currently challenging a $2 million jury verdict in a bellwether case over defects affecting its vaginal mesh product.
Counsel for the parties did not immediately return requests for comment on Thursday.
The plaintiff is represented by Irene McLafferty of Messa & Associates PC.
The defendants are represented by Andrew Trevelise and Debra A. Djupman of Reed Smith LLP.
The case is Runner v. C.R. Bard Inc. et al., case number 2:14-cv-05259, in the U.S. District Court for the Eastern District of Pennsylvania. -
Robot-assisted surgery for pelvic organ prolapse
Jun 4, 2015 | 7 KPLC
By Britney Glaser
Whether it is having a baby, aging, undergoing a hysterectomy or gaining weight, many women will develop a condition where their pelvic floor organs begin to fall or prolapse. That can impact more than the quality of life. Left untreated, you could develop a host of medical complications.
When the connective tissues weaken, these organs (vagina, uterus, bladder and rectum) can begin to bulge or sag, known as prolapse. This is a condition Lake Area Medical Center urologist, Dr. Kenneth Ewane, sees frequently. "Usually they are suspended in the pelvis and when they prolapse, they fall out of place," he said.
Dr. Ewane says that can impact urinary and bowel function, cause pain and pressure, as well as sexual dysfunction.
The only way to fully restore function is through a prolapse surgery, something that now can be done with the da Vinci robotic surgical system through six tiny incisions, versus one large cut. "When we go into the abdomen and into the pelvis, we dissect the vagina free from the bladder and from the rectum," said Dr. Ewane. "When you're separated those two fascial layers, you're able to position the mesh in between those two layers, sandwiching the vagina and lifting it up."
The da Vinci system features a magnified 3D, high definition vision system and special wristed instruments that bend and rotate much greater than the human wrist. That allows the doctor to operate with enhanced vision, precision and control, all leading to a better recovery compared to a traditional open surgery. "They don't deal a lot with post-operative pain," said Dr. Ewane, "they leave the hospital in one to two days, compared to previously with the big incision, they had to be in the hospital for about a week."
Dr. Ewane says the robot-assisted prolapse surgery is best for younger, active women.No doubt you have heard the FDA warnings about surgical mesh concerns. This procedure is not the same as what occurs during transvaginal placement of mesh.
Many women do not show know they have prolapse until they experience pain or discomfort. A doctor can diagnose prolapse with a cotton swab test, a bladder function test or a pelvic-floor strength test.
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Advantage Therapy in Eveleth now offers pelvic floor rehabilitation
Jun 5, 2015 | Hometown Focus
Advantage Therapy in Eveleth offers therapy specifically related to women’s health issues and, together with the Fitzgerald Nursing Home and Rehab, Advantage Therapy has purchased computer software called Telesis. Physical therapist Kandice Lytton specializes in women’s health and pelvic floor rehabilitation at Advantage
Therapy.Where's the story?3 Points Mentioned
Pelvic floor rehabilitation is a specialty type of physical therapy that serves individuals who may be experiencing urinary incontinence, pelvic pain, pelvic organ prolapse, bladder dysfunction, pregnancy and post-partum symptoms. The computerized biofeedback therapy provides patients with a nonsurgical option to treat these conditions.
Telesis is sophisticated biofeedback software that interprets muscle activity from surface EMG electrodes placed on the patient’s skin. It is a non-invasive technique that is painless and relatively easy to perform. It provides the therapist with information that helps the therapist customize a treatment plan based on the patient’s needs.
The treatment plan is designed using pelvic muscle training and/or bladder training, and the biofeedback from the computerized software and surface EMG, or electromyography, a technique for recording the electrical activity produced by skeletal muscles. Goals of therapy include reducing the urgency to void, or urinate and improved ability to remain continent.
People who may be at increased risk for incontinence or pelvic floor dysfunction: Women of older age being overweight, pregnancy, hysterectomy, frequent urinary tract infection, and having given birth by C-section. Common symptoms or complaints include difficulty holding urine until the appropriate time to void or leaking urine when exercising, sneezing or coughing. Other symptoms include pelvic heaviness and pain of the lower back and sacroiliac joint in the pelvis.
Lytton explains “It is a unique therapy tool that when coupled with exercises, can provide the patient with immediate valuable feedback on performance, ensuring that they are focusing on the correct muscles. Telesis is used on the first examination and follow-up appointments to reduce or eliminate symptoms and improve quality of life.”
Lytton received her Bachelor of Science degree in biology from Carrol College in Montana, where she grew up. She studied at the Mayo Clinic College of Medicine School of Health Sciences in Rochester and graduated in 2012 with a doctorate of physical therapy. She then moved to the Iron Range with her family.
Advantage Therapy, Eveleth, is the first clinic on the Iron Range to use this combined treatment approach. Questions or appointments can be directed to 218-471-1447 or 218-744-7570
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