22 May 2018

Vaginal Mesh Manufacturer Ethicon Fails to Disclose Serious Health Risks to Physicians

ethicon vaginal mesh

According to a BBC Panorama investigation, Ethicon, a Johnson & Johnson subsidiary, failed to inform physicians that vaginal mesh implants had caused chronic pain and side effects in some patients.

In addition, the investigative report also discovered that a transvaginal mesh marketed in the UK had only been tested on 31 females and sheep before it was released to actual patients.

Since the late ’90s, mesh implants have been used for treating female patients suffering from incontinence or prolapse. Most women experience no adverse side effects, but there are some who’ve suffered debilitating and chronic pain.

Some of these women lost their ability to walk following the implant procedure. During December 2017, a 42-year-old woman died following a four-year bout of sepsis caused by her mesh implant.

Investigators also learned that back in 2009, the associated medical director working for Ethicon warned that the side effects information included on their leaflet was insufficient.

The company was describing these complications as being transitory, but the medical director and many patients say the side effects are actually permanent. The associate medical director even expressed this sentiment in an email.

Ethicon failed to update any of this information until 2015, and even then, declined to disclose that the complications could actually be permanent. Instead, they maintained that the transitory description was appropriate for the intended readers, trained pelvic floor surgeons.

They claimed the risks associated with the implants were properly identified for use in education materials given to physicians.

Surgeons need this information to be accurate in order to fully understand the risks associated with different medical devices or procedures. The instructions for use are often the first resource of information surgeons go to before beginning an implant procedure.

Physicians expect manufacturers to include a comprehensive list of potential risks and adverse side effects in these instructions so they can be fully understood and conveyed accurately to the patient.

The procedure is non-invasive an can take as little as 20 minutes in some circumstances. The net-like mesh implant is placed around the urethra by inserting it into the vagina. It provides support to the urethra by acting like sort of hammock.

The prolapse and incontinence its used to treat are conditions often caused by childbirth. Ethicon released its TVT mesh product in 2006 after testing only testing it on 31 women for a period of just five weeks.

By 2012, Ethicon’s TVT mesh implant had been withdrawn from the market. A Pennsylvania woman who received the implant in 2007 for incontinence subsequently suffered from a bout of chronic pain that eventually restricted her to using a mobility scooter and walking stick to get anywhere.

She filed a lawsuit against Ethicon and was awarded $57 million during September 2017. This is the pain she will be dealing with for the rest of her life.

She claims she would have never elected to have the procedure if she knew there was a possibility of being in a wheelchair or suffering from permanent disabilities for the rest of her life. Instead, she would have opted to have surgery for a simple stress urinary incontinence.

Ethicon is appealing the decision, claiming that all pelvic procedures pose the risk of developing complications, whether the mesh is used or not.

From 2007 through 2015, over 92,000 female patients in England reportedly received mesh implants. Experts estimate that more than 9 percent of these women have suffered health complication has a result of the implant. From 2006 to 2017, over 6,000 women in England and Wales used the National Health Service to have operations to remove the vaginal mesh plants.

There are already hundreds of female patients who’ve begun taking legal action against vaginal mesh manufacturers and the NHS over the implant procedures. While the NHS prescribes mesh implants across the UK, a Scotland review warns that the procedure should not be routine for those suffering from pelvic organ prolapse.

According to the Medicines and Healthcare Regulatory Agency, there have been over 1,000 adverse incidents from mesh implants reported since 2012.

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