Rush for profits: Vaginal mesh devices were barely tested and doctors were NOT told how dangerous they could be

For young women eager to start their families, the thought that one day they might suffer pelvic organ prolapse and have to face a hysterectomy or another invasive procedure is the last thing on their minds. Nonetheless, the Women’s Health Initiative warns that 44 percent of women experience some level of prolapse in their lifetimes, most of whom have had children.

Now, a shocking investigation by the BBC’s Panorama has found that vaginal mesh – which has increasingly become the treatment of choice for uterine prolapse in recent years – is both dangerous and ineffective, and the company that manufactures it went out of its way to hide that fact.

So, what exactly is uterine prolapse? The Mayo Clinic explains that the condition occurs when a woman’s pelvic floor muscles and ligaments stretch and weaken over time and can no longer effectively support her uterus. The uterus gradually begins to slip down and may protrude out of the vagina. While any woman can be affected by this condition, it is more common after menopause, in women with a BMI higher than 35, and in those who have had at least one vaginal birth. Other pelvic organs can also prolapse, including the bladder or rectum.

Symptoms include a sensation of heaviness or pulling in the pelvis, urinary problems, tissue protruding from the vagina, trouble having bowel movements, and difficulty with sexual intercourse.

Vaginal mesh was originally used with success to treat women with urinary incontinence. Then, around two decades ago, Johnson and Johnson began advocating its use for uterine prolapse. The product is marketed in the U.K. by a J&J subsidiary called Ethicon, under the name Gynecare TVT.

Vaginal mesh is inserted to repair damaged tissue and support prolapsed organs. The mesh is inserted vaginally or through the abdominal wall, and is secured with sutures or tissue fixation devices.

The Guardian explains that the complications of the procedure can be very serious:

These include mesh exposure and erosion – when the mesh pokes through the vaginal wall or cuts through internal tissue – vaginal scarring, fistula formation, painful sex, and pelvic, back and leg pains. Some of these complications may occur years after surgery and can be difficult to treat. And although serious complications appear to be rare, given the thousands of women who have had the implants, the numbers of women suffering adverse reactions is high.

And neither surgeons nor patients were given the opportunity to assess these risks accurately, because Johnson and Johnson covered them up. (Related: Woman awarded $70M after contracting cancer from Johnson & Johnson talcum powder.)

The Daily Mail recently reported:

The BBC Panorama investigation reveals that Ethicon produces ‘Instructions for Use’ (IFU) leaflets to accompany mesh products to explain how doctors should insert them. They also explain the ‘adverse reactions’, or risks, associated with surgery to help surgeons explain these to patients. But in 2009 an associate medical director at Ethicon warned that the statements about side effects in the IFU leaflets for mesh products were not sufficient.

The BBC investigation revealed that Ethicon’s then-associate medical director wanted the wording in these leaflets changed to warn that the side effects of these devices are not “transitory.” The company refused to do so, although the leaflets have been changed to reflect that some side effects are “permanent” since 2015.

This lack of accurate information left surgeons in the dark with regard to the true effects of using these devices for uterine prolapse – a lack of information which has left thousands of women around the world trying to cope with debilitating side effects. (Related:.)

Ethicon – and by extension Johnson and Johnson – is, of course, admitting nothing. A statement issued to the BBC noted:

While we empathise with those who have experienced complications, the vast majority of women with pelvic mesh see an improvement in their day to day lives. All surgical pelvic floor procedures – with and without mesh – come with the risk of developing complications.

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All in a day’s work for Big Pharma.

Sources for this article include:

DailyMail.co.uk

FloridaHospital.com

TheGuardian.com

MayoClinic.org