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Vaginal Mesh Study: Complications More Likely With Lower-Volume Surgeons
Sep 15, 2015 | WBUR - Boston's NPR News Station
By Rachel Zimmerman
How do you minimize risk when undergoing surgery, an inherently risky endeavor? -
New laser treatment for stress urinary incontinence
Sep 15, 2015 | Irish Medical Times
Dr Sabina Tabirca, SHO in Cork University Maternity Hospital, and Dr Barry O’Reilly, Consultant Obstetrician and Gynaecologist at CUMH and UCC, examine a new treatment plan for stress urinary incontinence that promises to revolutionise the management of the condition.
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Vaginal Mesh Study: Complications More Likely With Lower-Volume Surgeons
Sep 15, 2015 | WBUR - Boston's NPR News Station
By Rachel Zimmerman
How do you minimize risk when undergoing surgery, an inherently risky endeavor?
If you happen to be one of the thousands of women facing surgery to treat stress urinary incontinence (SUI) — that uncontrollable leakiness due to weakened pelvic muscles, and yet another injustice of middle-age — there’s one pretty clear path to lower risk: Find a surgeon who performs many, many of these operations.
In a new analysis, Canadian researchers reviewed 10 years of data from nearly 60,000 patients who had vaginal mesh surgically implanted to treat stress urinary incontinence. The study concludes: “Ten years after SUI mesh surgery, 1 of every 30 women may require a second procedure for mesh removal or revision. Patients of lower-volume surgeons have a 37% increased likelihood of having a complication.”
The findings, published in the journal JAMA Surgery, “support the regulatory statements that suggest that patients should be counseled regarding serious complications that can occur with mesh-based procedures for SUI and that surgeons should achieve expertise in their chosen procedure,” the researchers write.
In case you’ve missed it, vaginal mesh implants have been in the news lately — and the news isn’t good. In May, a Delaware jury awarded $100 million to a woman who sued Boston Scientific, one of the manufacturers of vaginal mesh devices, for negligence, breach of warranty and fraud. Many more cases are pending and regulators continue to scrutinize the devices.
Patients and advocacy groups have also raised major concerns about the safety of vaginal mesh, the study authors note, citing complications ranging from chronic pain (and specifically, pain during sex) and fistula to erosion of the mesh into the vagina, which can require multiple followup surgeries and, needless to say, emotional and physical distress. More than 50,000 women have joined class action lawsuits related to vaginal mesh complications after SUI and prolapse procedures, the study says.
In an editorial accompanying the new analysis, Quoc-Dien Trinh, MD, a urologic surgeon at Boston’s Brigham and Women’s Hospital and assistant professor of surgery at Harvard Medical School, writes: “Although the lay press has focused on the judicial aspect and the potential financial fallout for manufacturers, little attention has been paid to understanding the factors associated with adverse events after vaginal mesh-based procedures. ”
In an interview, Trinh, who also studies health outcomes and patient safety, said the relationship between surgical volume and outcome is well established; that is, the more you do. the better you are. But while patients tend to shop around for high-volume surgeons when considering very complex procedures, like for cancer or heart surgery, that scrutiny doesn’t always carry over for simpler surgeries. “It’s something that people often don’t think about,” Trinh said, “but the same relationship [high volume equals better outcomes] applies to the less complex, same day procedures. Though the complications from vaginal mesh surgery may not be life threatening, erosions and fistulas, these things can make your recovery and quality of life miserable.”
Of course, Trinh said, it’s sometimes unrealistic for people to demand the very best, most experienced surgeon for every procedure.
“There’s a balance between quality and convenience; not everyone needs to be operated on by someone who has done thousands of the procedures. But it’s still important to investigate the quality of the surgery they offer,” he said. “Surgical volume is an easily accessible quality metric. There are metrics that are harder to find, but the one you can ask up front is: How many have you done? You can’t necessarily measure surgical talent, but volume, at least, is somewhat reliable, and you can obtain the information.”
Authors of the recent vaginal mesh study note that the overall risk of complications is still relatively low. Nevertheless, there remains much controversy around the mesh implants. And some have suggested the whole endeavor is unwise.
Back in 2011, Bay Area pelvic surgeon Michael Thomas Margolis told an FDA advisory panel that the very idea of transvaginal surgery using synthetic mesh “defies core surgical doctrines” because the vagina is defined as “clean-contaminated” due to its normal flora, including Staph and E.coli bacteria, which “can not be surgically cleansed from the operative field.”
Dr. Margolis, who says he’s done scores of “salvage” operations on women with mesh complications, wrote: “The implantation of contaminated synthetic mesh through the vagina defies basic surgical tenets because by definition it is not performed in a sterile manner. In fact so-called ‘mesh erosion,’ the most common mesh complication, is in reality mesh infection with chronic wound breakdown.”
Dr. Trinh, the Brigham surgeon, says part of the problem involves patient expectations. He compares vaginal mesh surgery to robotic surgery, which, he says, has “probably been excessively marketed and so some patients have unrealistic expectations.”
“People have suffered serious, major complication after robotic surgery,” Trinh said. “But there are also benefits to the surgery. Doctors have to do a better job of explaining there’s a person behind this technology, but the literature shows there are also benefits to these technologies.”
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New laser treatment for stress urinary incontinence
Sep 15, 2015 | Irish Medical Times
Dr Sabina Tabirca, SHO in Cork University Maternity Hospital, andDr Barry O’Reilly, Consultant Obstetrician and Gynaecologist at CUMH and UCC, examine a new treatment plan for stress urinary incontinence that promises to revolutionise the management of the condition.
Stress urinary incontinence (SUI) is defined as the involuntary loss of urine with any increase in intra-abdominal pressure such as coughing, sneezing, laughing or running, in the absence of a bladder contraction. Although it is not a life-threatening condition, it can seriously impact on the physical, psychological and social well-being of women.
Urinary incontinence is associated with depression, anxiety and work or social isolation. Coital incontinence affects one-third of women with UI, therefore adversely impacting on interpersonal relationships.
Aetiology
SUI is the most common type of urinary incontinence affecting up to 14 per cent of young women and it increases with age in up to 35 per cent of older women.There are two reasons why women might suffer from SUI: urethral hypermobility or intrinsic sphincter deficiency. Urethral hypermobility occurs when the pelvic floor muscles and vaginal connective tissue do not support the urethra and bladder neck properly, i.e. inability of the urethra to close against the anterior vaginal wall with increase in intra-
abdominal pressure.Chronic pressure such as obesity and chronic cough or trauma such as childbirth leads to connective tissue damage that causes urethral hypermobility.
Intrinsic sphincter deficiency is another form of SUI. This is a severe form of SUI and occurs when there is loss of the urethral muscular tone after a neuromuscular insult such as multiple pelvic surgeries.
Rick factors for urinary incontinence include: 1) obesity, 2) parity, 3) mode of delivery, 4) family history, 5) age, 6) ethnicity race, 7) others i.e. smoking, caffeine intake, diabetes, stroke, depression, vaginal atrophy etc.
Treatment options
Many treatment options are available to tackle this condition. These vary from non-surgical to surgical options, and not every option will suit everyone. Lifestyle modification is key to addressing this problem. Losing weight significantly decrease the severity of SUI. Smoking, constipation and dietary changes are also very important in improving symptoms.Pelvic floor exercises (PFE) or Kegel exercises strengthen the pelvic floor musculature. This involves three sets of eight-to-12 contractions lasting for around 10 seconds, performed three times per day, for at least 15-to-20 weeks. In women who are not suitable for PFE vaginal pessaries could be of help. Continence pessaries are placed in the vagina and replaced every six months. These have shown to have a success rate of up to 50 per cent.
No pharmacological therapy has been approved by the FDA for the treatment of SUI. Duloxetine, a serotonin and noradrenaline reuptake inhibitor (SNRI), has been shown to have an effect. However, this is not routinely used because of the adverse effect profile.
Women who have no improvement in symptoms with conservative measures could benefit from surgical interventions. These include mid-urethral sling, injection of urethral bulking agents and other older procedures such as Burch retropubic colposuspension.
However, not everyone is suitable for surgical intervention. For women with a high body mass index (BMI), other significant medical co-morbidities, or those who have not yet completed their families, surgical options are not advisable.
Novel treatment
It is known that women with SUI have a decrease in the quality and quantity of the collagen composition. Laser therapy targets the collagen tissue by enhancing its structure and stimulating neocollagenesis. As a result, the triple helix of collagen shortens and gives immediate tightening of collagen fibres by up to two-thirds.This method of treatment is specifically important in women who are not suited for surgery, those who have a mild-to-moderate SUI and for those who desire to have more children.
Laser therapy has been use in medicine for decades. There are many types of laser systems and they have been used to treat or improve symptoms in areas such as dermatology, oncology, ophthalmology, gynaecology or urology.
Carbon dioxide (CO2) laser is commonly used in gynaecology to treat conditions of the cervix, vagina, vulva and perineum. CO2 lasers have been utilised trans-vaginally to counter the effects of urogenital ageing. However, the CO2 laser is a very ablative form of therapy.
Erbium (Er:YAG) is a novel therapy system that has preceded CO2 lasers. Er:YAG is a non-ablative laser treatment, therefore the tissue is coagulated and shrinks but it is not removed. There are also emerging applications for the Er:YAG trans-vaginal laser including vaginal laxity, mild prolapsed and vaginal atrophy.
IncontiLaseTM is a minimally invasive Er:YAG laser technique that enables collagen remodelling, ideal for mild-to-moderate stress incontinence. Laser energy is applied to the vaginal mucosa and the collagen in the tissue suddenly contracts the fibres.
In turn, this leads to the contraction and shrinking of the irradiated tissue. The thermal effect on collagen continues throughout the process of remodelling and neocollagenesis, resulting in the generation of new collage.
Practically, this is an office-based procedure and it involves an erbium laser probe to be inserted into the vagina for 20 minutes.
It is painless, involves no ablation, cutting or suturing. There is a rapid return to normal activities and the patient can walk out of the treatment room immediately after it is done. Usually two sessions are recommended. This will completely revolutionise the way SUI is addressed in our society.
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