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Surgical procedure broadcast live during hospital’s workshop
Apr 16, 2016 | The Star Online
By T. Avineshwaran
... Prolapse surgery addresses a weakness in vaginal support that results in a protrusion of the vaginal wall. -
Why every new mom needs physical therapy
Apr 17, 2016 | Fox News Health
By Julie Revelant
After she gave birth to her son, Valerie Orsoni knew what to expect: a prescription from her doctor for 12 sessions of physical therapy to rehabilitate her pelvic floor muscles. -
FDA’s Banning Authority: Still Only for Hard Cases
Apr 15, 2016 | Medical Device and Diagnostic Industry Online
By Nancy Stade
FDA’s recent proposal to ban powdered gloves follows impassioned calls from patient advocates and consumer groups to ban a host of other devices, including metal-on-metal hip implants, vaginal mesh, and power morcellators.
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Surgical procedure broadcast live during hospital’s workshop
Apr 16, 2016 | The Star Online
By T. Avineshwaran
DOCTORS are usually busy saving lives, but there are some out there who also want to impart their knowledge to other practitioners.
KPJ Ipoh Specialist Hospital CEO Asmadi Mohd Bakri said many doctors in KPJ love to teach and want to help others learn.
To boost the sharing of knowledge the hospital organises an annual course on Minimally Invasive Gynaecological Surgery for gynaecology specialists around Malaysia.
Obstetrician and Gynaecolgist Consultant Dr T. Divakaran, who was instrumental in organising the past two courses, also played organiser for this year’s course.
The subject of this year’s edition was “New insights in laparoscopic prolapse surgery: To Mmesh or not to mesh”.
Prolapse surgery addresses a weakness in vaginal support that results in a protrusion of the vaginal wall.
This occurs during activities that increases the pressure inside the abdomen and pelvic floor such as heavy lifting or straining, coughing or during bowel movement.
For the workshop, two experienced doctors performed two surgeries that were telecast live for the workshop participants.
Prominent laparoscopic surgeon from India, Dr Paul PG conducted the first operation and gave a glimpse of what happens in the operation theatre during laparoscopic prolapse surgery.
Participants had to wear 3D glasses to watch the surgery and also took the opportunity to ask questions via teleconferencing.
The surgery did not deter Dr Paul from answering the questions as he showed the methods to perform the surgery.
He explained the use of keyhole instruments during the surgery and how permanent stitches are placed between the top of the vagina and the supportive structures adjacent to it.
The surgical method demonstrated allows good visualisation for doctors to assess the tissue to be repaired that does not involve opening the vagina and avoids shortening or narrowing the vagina.
Dr Paul has performed more than 20,000 advanced endoscopic surgical procedures and is widely known for his expertise.
He has conducted live endoscopic workshops in India and also abroad.
Another doctor who conducted a surgical demonstration was Dr S. Selva, who is also a Consultant Obstetrician and Gynaecologist and a sub-specialist in Reproductive Medicine at the Mahkota Medical Centre in Malacca.
Both doctors performed six live surgeries on six patients with various complications using the laparascopic prolapse surgical technique.
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Why every new mom needs physical therapy
Apr 17, 2016 | Fox News Health
By Julie Revelant
After she gave birth to her son, Valerie Orsoni knew what to expect: a prescription from her doctor for 12 sessions of physical therapy to rehabilitate her pelvic floor muscles.
“Even when you’re a little girl in France, your mom always tells you to stay stretched and to always tuck in your tummy and contract your abs. When you do that, naturally it leads to contracting the perineum,” Orsoni, 45, the founder of Lebodychallenge.com, said.
After the birth of her son, now 19, Orsoni underwent biofeedback, a treatment that uses an electrode or probe inserted into the vagina to measure the strength of the pelvic floor muscles and to help ensure that Kegel exercises are done correctly.
Although she was prepared for it, Orsoni admits she was a little embarrassed. “At first, it’s pretty surprising. They’re putting something in your vagina,” she recalled.
Orsoni, who now lives in San Francisco, Calif., said postpartum rehabilitation is so important in fact that doctors in France won’t give women the green light to start exercising again without completing the two-to-three month program.
“The worst thing that you could do would be to go back to doing regular exercises after giving birth without doing perineum rehab,” she said.
Rehab for your pelvis and abs
After giving birth, it’s common for women to deal with issues like urinary incontinence, diastasis recti— a separation of the rectus abdominis muscle— and pelvic pain.
In fact, approximately 85 percent of women have pain the first time they have sex after childbirth and nearly a quarter of them still do at 18 months postpartum, a recent study in the journal BJOG found.
“Most moms are in pain after birth and they just figure it’s common and normal but there is treatment for it. They don’t have to live with it,” said Marianne Ryan, a physical therapist in New York City and author of “Baby Bod: Turn Flab to Fab in 12 Weeks Flat.”
In France and other countries like the Netherlands and Australia, postpartum physical therapy is a common treatment to help women recover from the rigors of childbirth. Yet in the United States, women have a 6-week postpartum check-up and are told to resume their normal activities.
“Not only do we do nothing in the U.S., but also if a woman goes to her physician, particularly her obstetrician, with these complaints after delivery it’s written off as ‘Well, you just had a baby,’” said Stephanie Prendergast, co-founder of The Pelvic Health and Rehabilitation Center in Los Angeles, Calif. and author of “Pelvic Pain Explained.”
“While that’s true, there are still musculoskeletal implications that come with both pregnancy, labor and delivery and of course, C-section,” she said.
Although they might be well-intentioned, OB-GYN’s are not trained to identify pelvic floor or abdominal problems like physical therapists are, Prendergast said.
Another issue is that although women are encouraged to do Kegel exercises, doing so can make perineal tears worse. What’s more, a study in the journalFemale Pelvic Medicine & Reconstructive Surgery found that 23 percent of women who said they knew how to do Kegel exercises did not do them correctly.
If problems are left untreated, over time they can lead to low-back pain and hip problems, urinary and bowel function issues such as urgency, frequency, burning, constipation, anal pain, and infection and pelvic organ prolapse, a condition in which the bladder, uterus or other organs descend into the vagina, Prendergast said.
What’s more, studies show that even if women feel fine after childbirth, it could take between 6 and 10 years until these issues become a problem.
How physical therapy can help
“In an ideal world, everybody should have an evaluation to identify what their particular issues are and get a specialized home program,” Prendergast said.
A physical therapist can help identify impairments in the tissues, muscles, nerves and joints and evaluate the abdominal wall and the pelvic floor muscles to determine what has changed during pregnancy, labor and delivery.
Once the issues are identified, women are given an individualized program to help the muscles heal, improve urinary, bowel and sexual function as well as the overall stability of the pelvis so they can do things like pick up their babies, Prendergast said.
Physical therapists can also help moms do daily tasks in a way that doesn’t put pressure on the abdominal muscles, or even teach them how to have a bowel movement without straining the pelvic floor muscles, Ryan said.
Biofeedback, the therapy Orsoni used, can help, especially for those women who have recently given birth and find it hard to pinpoint their pelvic floor muscles. It can also help identify a temporary neuropathy, or damage along the nerve that controls the muscles.
“They may need electrical stimulation to help those muscles fire if the nerve can’t direct the muscle to do so itself,” Prendergast said.
Caring for a new baby can leave little time for sleep, a shower or a workout, much less multiple physical therapy sessions. Yet experts agree it’s one of the best things women can do for their health, both right after childbirth and in the future.
“Women deserve treatment,” Ryan said. “Your body is not going to just magically snap back together.”
Julie Revelant is a health journalist and a consultant who provides content marketing and copywriting services for the healthcare industry. She's also a mom of two. Learn more about Julie at revelantwriting.com.
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FDA’s Banning Authority: Still Only for Hard Cases
Apr 15, 2016 | Medical Device and Diagnostic Industry Online
By Nancy Stade
FDA’s recent proposal to ban powdered gloves follows impassioned calls from patient advocates and consumer groups to ban a host of other devices, including metal-on-metal hip implants, vaginal mesh, and power morcellators. Each of these has been the subject of FDA safety communications and high profile campaigns led by patient and consumer advocates; in contrast, the campaign to ban gloves has been relatively low key, and sustained over several decades largely by a physician who filed multiple petitions with FDA before his death in 2014. Why is FDA proposing a ban for powdered gloves while, at least to date, the agency shows no signs of pursuing a ban for other devices that have raised patient safety concerns?
Part of the answer lies in the standard for banning. Section 516 of the Federal Food, Drug, and Cosmetic Act (FDCA) grants FDA the authority to ban, by regulation, any device the agency finds to present “an unreasonable and substantial risk of illness or injury” when that risk cannot be “corrected or eliminated by labeling or [a] change in labeling.” (21 U.S.C. § 360f.)
“Unreasonable” may be the key concept in FDA’s recent proposal, which describes serious risks of powdered gloves including acute respiratory reactions, inflammation, and granulomas, risks that greatly exceed the only identified benefit of increased ease in donning the gloves for healthcare workers. In short, powdered gloves carry serious health risks and no apparent upside to patients in increased safety or effectiveness when compared to alternatives (such as unpowdered gloves). In contrast, where potential clinical benefits exist, FDA may take measures that do not require the removal of the device from the market place, such as clinical studies to show how the risks and benefits stack up in specific subpopulations, and revised labeling to tilt the balance in favor of a benefit to patients by improving instructions for use or contraindicating certain uses.
Another device that has prompted calls for a ban seems, at least at first, to have the same characteristics as powdered gloves of a lopsided risk-benefit profile and minimal current use. That device is the electrical stimulation device (ESD), known to be used only at Judge Rotenberg Center (JRC) in Massachusetts to provide aversive conditioning to patients with self-injurious behavior (SIB) and aggressive behavior who had been diagnosed with autism or other developmental disabilities. The news program 20/20 ran a highly critical segment investigating JRC practices in using ESD and a UN report has likened use of the device to torture.
In 2014, FDA convened a panel to consider whether the ESD meets the standard for a ban. Although a slim majority of the panel concluded that the device presents an unreasonable and substantial risk of illness or injury, the panel made additional findings that could complicate FDA’s analysis of whether the device is an appropriate banning candidate. In particular, the panel found that though available evidence did not establish a clinical benefit for ESD, many panel members noted the poor quality of available data, and a majority concluded that the device could be ethically studied under tightly controlled conditions.
With powdered gloves, FDA seems to be treating banning as a last resort, using its authority only when a device has no demonstrated clinical benefit. When FDA finds a device has potential clinical benefit that can be further studied or controlled by limiting use to a subpopulation, improving device labeling, or otherwise controlling how the device is used, FDA has relied on authorities other than banning to address device safety issues. Because the gulf between the risks of the ESD and its known benefits is so great, the device challenges this past practice and raises the question of when, if ever, banning is the right response when a potential clinical benefit for a population with few options exists.
The extent of the imbalance between risks and benefits for the ESD may not be the factor to decide that question. The comparison of ESD to torture makes ESD qualitatively different from other devices where FDA seems to have opted against a ban despite public outcry. Arguably, the comparison makes risk-benefit analysis completely inapt, and could cause FDA to expand its definition of what constitutes an “unreasonable” risk warranting exercise of this extraordinary authority.
Nancy Stade, JD is a partner at Sidley Austin LLP in Washington, DC. She has extensive prior experience at FDA, including as deputy director for policy at CDRH and counselor in the Office of the Commissioner.
The views expressed in this article are exclusively those of the author and do not necessarily reflect those of Sidley Austin LLP and its partners. This article has been prepared for informational purposes only and does not constitute legal advice. This information is not intended to create, and receipt of it does not constitute, a lawyer-client relationship. Readers should not act upon this without seeking advice from professional advisers.
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