Women's Health

New Findings Point Finger at Possible Fibromyalgia Causes

New Findings Point Finger at Possible Fibromyalgia Causes

Often the reason that patients receive transvaginal mesh implants is to control something called stress incontinence. Stress incontinence is a condition that often leads to women leaking urine from their bladder when doing high impact activities (running, jumping) or even from smaller catalysts, like coughing or sneezing. Stress incontinence impacts about 20% of women, usually after childbirth and around menopause.

These meshes are also used to treat women who are living with pelvic organ prolapse. Pelvic organ prolapse is basically when a pelvic organ, like the bladder, “sags” and is shifted out of place during the pregnancy process. This impacts around 50% of women who have had children. Often this can happen when the pelvic floor muscles, ligaments, and tissue that hold the organs are weak or damaged. 

The current controversy around vaginal mesh implants takes place because many of the short-term clinical trials found that while there was a high rate of efficacy and low complications in terms of incontinence, there has been growing evidence that shows that it has the opposite effect on pelvic organ prolapse.

Studies also suggest that the complication rates reported may be misleadingly low. Studies in the UK by the NHS show that one in 15 women will eventually have to have their mesh implant surgically removed.

Sling the Mesh Campaign

The Sling the Mesh Campaign is run by women who are demanding that an operation with a lot of negative life-changing risks be suspended in the UK. The UK-based organization also plans and implements a fibromyalgia awareness campaign.

This organization has made huge leaps in the recent months, including joining the Scottish Mesh Survivors to speak at the Australian senate inquiry into mesh implants. They continued their pressure on the government in September of 2017 by launching the All Party Parliamentary Group APPG, which will be chaired by Owen Smith and Paul Masterson as well as other medical practitioners. The formal advisers will be surgeon Suzy Elneil and the founder of the organization, Kath Sansom.

The organization has a lot of resources for patients effect by the negative side effects of mesh implants, including group action options and more individualized options

The organization’s website says that Sling the Mesh calls for “a full investigation and audit to be carried out into how many women have been adversely affected by vaginal mesh implants and tapes. We want the NHS to write every woman who has had the operation.” Their mission statement showcases their dedication to find individual help for each woman negatively affected by these implants as well as taking steps to work on a larger scale.

The Campaign’s future plans include starting a National Register for mesh implants. The idea behind this is that patients would be tracked for her lifespan. They also want to bring the NICE guidelines for mesh incontinence to light. The next upcoming review is not going to take place until 2019.

The organization’s main problem with the English Mesh review which was published in 2017 is that it was not received as accurate. In fact, the review has been called “a whitewash” and been accused of missing vital information and not taking the safety of the mesh implant nor the implementation of it seriously.

Part of what makes the organization so strong is that it was founded by a woman who suffered what a lot of the women joining the campaign suffered from. After realizing that her botched Mesh implant was a part of a worldwide women’s medical problem, Kath Sansom started the campaign only ten weeks after her initial operation.

Fibromyalgia and Mesh Implants

The Sling the Mesh support group for women who have been negatively impacted by mesh implants found that 54 out of 187 people had developed a diagnosable form of fibromyalgia after having the polypropylene playact implant inserted into them.

According to a Landmark report, 9.8% of women experience complications due to their incontinence mesh implant in the UK.

A study conducted by Fayaz, Croft, Langford, Donaldson, and Jones found that the 5.4% of the overall population lives with fibromyalgia.

A Sling the Mesh spokesperson said, “Our survey shows the incidence of fibromyalgia in mesh patients is six times higher than what one would expect for the overall population. In mesh support groups globally we see people talking of the debilitating effects of this autoimmune condition which is why we decided to nail down some figures. In addition to those with a diagnosis, a further 51 said they had many of the symptoms but have not yet received a formal diagnosis- 27.2%. There were also 40 people who have developed inflammatory arthritis, one in five people."

Previous Findings

This finding contradicts the reports published earlier in 2017 by an American-based surgeon who wrote that he denied the plastic implants can be the catalyst for the development of autoimmune diseases.

Because of the rules of transparency in play in America, medical professionals are required to declare their conflicts of interests online, the NY-based surgeon who spearheaded the aforementioned study also took industry-funding for the study. In fact, the surgeon had $117,423.20 from industry funding and $22,350.85 in overall payments in the calendar year leading up to the report’s publication.

Dr. Bilal Chugtai, who was the main author in the May 2017 study, said “we found not relationship exposures to vaginal mess and subsequent development of Systemic Inflammatory and Autoimmune Diseases (SAID). Mesh has been placed under additional scrutiny with concerns on consumer world wide web sites about the association of mesh and the subsequent development of systemic autoimmune diseases. There is growing uncertainty among patients regarding long-term safety of these procedures, which have been associated with high success rates.”

Studies completed using animal participants have showcased that mesh actually causes inflammation, foreign body reaction, and fibrosis. Patient support groups, such as the Sling the Mesh Campaign, reported autoimmune disorders like lupus, fibromyalgia, and rheumatoid arthritis.

Dr. Chugtai vehemently shooed away theories that suggested that chronic foreign body responses actually leads to oxidization. This oxidization causes the polypropylene to break down. This is confirmed by a study on explanted mesh. The study in question was spearheaded by Professor Iakovlev.

“The process of mesh degradation has not been confirmed in beings and remains controversial,” Chugtai said. “The occurrence of SAID may be events unrelated to the preceding mesh placement Vaginal mesh has been used for decades, and synthetic slings for stress urinary incontinence are considered the gold. “

What People are Saying

In 2013, the BMJ published a piece by journalist and founder and editor of Pharmalot blog, Ed Silverman. Silverman wrote that the open payment declaration system in America was “Expected to usher in a new er of transparency regarding the financial relationships between doctors and the makers of drugs and devices.”

Many things can fall under the umbrella of payment, including consulting and speaking costs, meals, gifts, and research funding. People find this upsetting because these financial and other comped deals can “unduly influence medical practice and research,” Silverman wrote.

Ed Silverman has over two decades of experience when it comes to pharmaceutical industry news.

However, some patients remain confident. The support group Fibromyalgia Action UK said “Gone are the days when GPS told us that there was no such thing as fibromyalgia and that was all in our heads. The NHS now accepts fibromyalgia as a ‘real’ chronic illness.