pelvic vaginal mesh stress urinary incontinence Polypropylene vaginal mesh

Study Shows Advantages for Stress Urinary Incontinence Surgery

One of the most commonly performed surgeries to treat stress urinary incontinence in women may have better long-term results than another common surgical technique, according to a study led by Mayo Clinic researchers.  The retrospective study of more than 1,800 cases at Mayo Clinic from 2002 to 2012 found that the need for additional surgery was twice as high after a transobturator sling surgery compared with a retropubic sling procedure. Reoperation rates within eight years after surgery were 11.2 percent for patients in the transobturator group compared with 5.2 percent in the retropubic group, according to the study, which will be published in the journal Obstetrics and Gynecology in August. Read more.

Source: Austin Daily Herald, July 16, 2019

pelvic vaginal mesh stress urinary incontinence Polypropylene vaginal mesh

FDA Halts All Sales of Pelvic Mesh Products Tied to Injuries in Women

The U.S. Food and Drug Administration on Tuesday announced a ban on the sale of all pelvic mesh products.  The surgical mesh is typically used to repair pelvic organ prolapse (POP) and incontinence, but reported side effects have included permanent incontinence, severe discomfort and an inability to have sex.  “In order for these mesh devices to stay on the market, we determined that we needed evidence that they worked better than surgery without the use of mesh to repair POP,” said Dr. Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health. “That evidence was lacking in these premarket applications, and we couldn’t assure women that these devices were safe and effective long term.” Read more.

Source: HealthDay News, April 16, 2019

pelvic vaginal mesh stress urinary incontinence Polypropylene vaginal mesh

BD withdraws surgical mesh products for SUI and POP

A spokesperson said: “BD has decided to discontinue the manufacture and sale of pelvic organ prolapse and stress urinary incontinence products in all remaining markets worldwide. While thousands of women over many years have benefited from the safe use of these products, we have decided to stop production of these devices to focus on other strategic priorities rather than continue to invest in clinical data to support additional EU requirements.”  The government website says there is no need for implanted devices to be removed and no additional follow-up is required for patients implanted with such devices but anyone who has any concerns about their implanted device should contact their GP. Read more.

Source: Medical Plastics News, March 7, 2019

operating room surgery

London Researchers Examine Psychological Fallout of Incontinence Surgery Complications

London researchers are zeroing in on the potential psychological effects of complications from women’s incontinence surgery, uncovering an increased risk of depression and self-harm after the corrective surgery.  Researchers at the Western University branch of Toronto-based Institute for Clinical Evaluative Sciences and Lawson Health Research Institute — the research arm of the London Health Sciences Centre and St. Joseph’s Health Care London — examined patient outcomes after pelvic mesh implants from January 2004 to December 2012. Using 12 years of data from Ontario’s public health-care system, researchers studied the files of 57,611 women who underwent the midurethral mesh sling procedure during the study period. Of those, 1,586 went under the knife again to correct a complication from the mesh. Read more.

Source: The London Free Press, January 9, 2019

pelvic vaginal mesh stress urinary incontinence Polypropylene vaginal mesh

Mesh ‘Last Option’ for Incontinence

Women who need treatment for urinary incontinence should only be offered mesh surgery as a last resort, new draft guidelines for the NHS advise. The National Institute for Health and Care Excellence (NICE) says non-surgical options, like pelvic muscle exercises, are the first to turn to. The NHS in England has already put restrictions on mesh operations after safety concerns. Many women say the implants cause agony by cutting into tissue. It is estimated that more than 100,000 UK women have had a mesh fitted. The net-like fabric can be attached into the wall of the vagina to act as a scaffold to support organs, such as the bladder, to keep them in the right place to help manage incontinence or another condition called prolapse.  Read more.

Source: BBC News, October 9, 2018

surgeons perform pelvic organ prolapse surgery

New Zealand’s Medsafe regulatory body removes pelvic mesh products from market

New Zealand’s regulatory body Medsafe has taken steps to remove a number of surgical mesh products from the country, according to a release posted today. The agency said the product’s removal was the outcome of a recent regulatory action on surgical mesh products, specifically those designed for treating pelvic organ prolapse via transvaginal implantation and one mini-sling product designed to treat stress urinary incontinence. Medsafe said that last December it requested safety information from four surgical mesh suppliers in New Zealand, following action taken by Australia’s TGA as it looked to review meshes used for urogynaecological use. The earlier TGA’s investigation ended in regulatory actions to remove the devices from the market, MedSafe said, and similarly resulted in their removal from New Zealand’s market. Read more.

Source: +Mass Device, January 31, 2018

operating room surgery

Vaginal Mesh Operations Should Be Banned, Says NICE

The health watchdog NICE is to recommend that vaginal mesh operations should be banned from treating organ prolapse in England, the BBC’s Victoria Derbyshire show has learned.  Draft guidelines from NICE say the implants should only be used for research – and not routine operations.  Some implants can cut into the vagina and women have been left in permanent pain, unable to walk, work or have sex.  One expert said it is highly likely the NHS will take up the recommendation.  However, the organisation is not compelled to act on findings it receives from NICE.  Both NHS England and NICE declined to comment. Read more.

Source: BBC News, November 27, 2017

My Transvaginal Mesh Surgery

My Story – Submitted by: Mary

I am a 53-year old woman who had a hysterectomy for cervical cancer at 27 and chronic bronchitis in my 40’s. This caused my incontinence and I was told I would get relief if I had the transvaginal mesh implanted. I had the surgery in 2009, both bladder and rectal repairs.

Since then, I have had nothing but problems. The mesh is eroding out of my vagina, my bladder has fallen again, I cannot empty my bladder totally, have the urge to urinate often and I leak constantly. I also can’t be intimate with my husband without pain. That is not even close to being the worst of it.Continue reading

Pelvic Organ Prolapse (POP) Surgery

surgeons perform pelvic organ prolapse surgery

Pelvic organ prolapse surgery should only be done by a highly qualified and skilled surgeon.

There are several different types of surgeries performed for the treatment of pelvic organ prolapse (POP). The kind of surgery used is dependent on the type of prolapse (bladder, womb or end of vagina, uterine, or bowel).  Sometimes, when the patient is experiencing stress urinary incontinence, the surgeon can perform an anti-incontinence surgery, (most likely a loose sling under the neck of the bladder) during the prolapse surgery for treatment of stress urinary incontinence.Continue reading