Wednesday, 18 February 2015

Transvaginal mesh or also called vaginal mesh is a product that is used to repair a pelvic organ prolapse and stress urinary incontinence. According to Wikipedia, Pelvic organ prolapse is when organs in the female pelvis moves out of position as a woman grows older. That often causes discomfort and other conditions and so it needs to be repaired. That’s been happening hundreds of years in the lives of women but in the past probably ten years, instead of using traditional procedures, they’ve been using mesh to try to repair those problems and that has caused a lot of difficulties in the lives of women.

In the course of a year there are probably 500 000 procedures that are done whether it’s for pelvic organ prolapse repair or stress urinary incontinence. The latter are probably the most common and for many women stress urinary incontinence is something that’s not my really discussed as it’s a sort of embarrassing. These kind of procedures to repair those problems are done in hundreds of thousands of women each year and until the last two years those procedures were done using traditional sutures or native tissue repair. When other medical devices were introduced to address those conditions that’s when those really challenging problems started to occur.

for the large majority of women they are implanted with mesh. And when we say transvaginal mesh we are really talking about is a polypropylene mesh that is used to move your organs back into place. What is actually polypropylene? Fishing wire actually is made out of polypropylene. A lot of things are made of polypropylene and that material can cause some significant problems when it’s placed into the female pelvis. The grand majority of procedures now for stress urinary incontinence use polypropylene or trainsvaginal mesh. For pelvic organ prolapse, until recently, these procedures were done also using pelvic mesh or transvaginal mesh until recently the FDA put out a bulletin that really has cost a lot of doctors to rethink what they were using for pelvic organ prolapse.
Are These Vaginal Mesh Products Actually Approved By The FDA?

Medical devices are governed by the medical device Safety Act (FDA). These products are placed on the market often without testing in humans which is a surprise really to patients who receive them in a position to place these products. So there is no testing for safety by the FDA. There’s no review of studies in humans for the FDA to make a decision about safety. These products are really placed on the market with minimal testing. They call it a “lab bench testing” and we feel like that’s when the huge problems are associated with these products. The only testing that manufacturers do on these products prior to placing them in hundreds and thousands of women is they are placed in cadavers. Cadavers are actually bodies of people that have died and have been used for experiments. That is unreal, unrealistic way to try learning if these products are safe for the female and female pelvis which is a very dynamic part of your body.

What Injuries Are Caused By Transvaginal Mesh?

That’s really the saddest part to this story. The problems are everything from erosion of the mesh through the vaginal wall which is very painful, that can be nerve pain that causes chronic pelvic pain that is often 24/7 type of pain that women experience. They also can have permanent incontinence both urinary incontinence and fecal incontinence and painful intercourse as well as chronic infection. So these injuries cause tremendous quality of life problems for the women who experience them.
What Is It About The Transvaginal Mesh That Causes These Issues?

There are number of things that can cause these type of problems in women. One of the huge things is the way that these products are implanted in women and can cause a tremendous nerve pain. They are implanted through incisions into the vaginal wall and then through trocars that really cut through bridge areas that can cause a lot of difficulty for women. The other thing is the mesh which manufactures represent to the FDA would not change once it was placed in the body. In fact it does change. It begins to degrade and and when it degrades there are particles that are sloughed off essentially into the cavity of the woman and that can cause inflammatory responses that leads to a lot of the chronic pain as well. Scarring chronic pain results from that type of inflammatory response that is caused by the mesh breaking down within the body. For many these women the treatment options are very limited. What the manufacturers told the FDA was not the whole story or not the true story essentially. What you’re seeing proven through the course of litigation is FACS being established showing that in fact when the mesh is placed within the body it does break down. We are seeing the manufactures now be held accountable for those statements to the FDA. To date the FDA has not taken any action on some of those statements.

The FDA actually required the manufactures to performstudies in actual patients.You think that would have been donelong before these products were placed on the market but it hadn’t been done. So the FDA required manufactures to do what they call “Section 5 22 studies” in order to keep the products on the market the manufacturers (these were primarily for pelvic organ prolapse products) had to perform studiesin patients.

The risk was much greater than the benefit to these patients and then most of the pelvic organ prolapse products were taken off the market. Thereare still remains of products forstress urinary incontinence but large portion of the pelvic organ prolapse products now have been removed. This is primarily because not only with the FDA did in requiring thosestudies but alsobecause of the accountability. If FDA didn’t put pressure on the manufacturers, then these products would still be on the market.

What Is The Failure Rate Of Vaginal Mesh Procedures?

The failure rate is 10 to 25% depending on the product that is used and the type of procedure that is done. For pelvic organ prolapse patients up to 25% of the ones who had received certain products will experience difficulties over their lifetime. You have to remember that these products are placed and they are intended to stay in the woman’s body for a lifetime. Where as some women don’t experience problems immediately but usually three, four, five years down the road they can begin to experience problems as that inflammatory process continues to escalate. In July, 2011 the FDA issued another bulletin but this time it was very strongly worded that basically establishing that for pelvic organ prolapse repair that the use of mesh was not appropriate unless it was some extraordinary circumstances where traditional procedure was not an option. That was really the first time for physicians and for a lot of patients to understand that this is a serious problem and it’s something that needs to be addressed. For physicians in particular their habits in terms of what they were recommending to their patients really changed at that point. Physicians who were implanting vaginal mesh into their patients had no idea they have never been tested in patients prior to being placed on the market, they had no understanding of the true failure rate for these products. They vast majority of the health magazines and literature about transvaginal mesh were sponsored and manipulated by the manufacturers of the products. It was really marketing pieces rather than true scientific studies and so for a lot of physicians that look back and now realize they weren’t told the truth. They were not given all the information they needed in order to make an informed decision about the risk and the benefits of these products. Many women went into these procedures thinking that there was low risk and a large benefit. This is particularly true for those women who had stress urinaryincontinence proceduresthey had no idea that what they thought was going to be a very simpleoutpatient procedure could result inthen having chronic pain for the rest of their life.

Which Are The Primary Manufacturers?

There are number of manufactures but the primary ones are Bard, Boston Scientific, Johnson & Johnson and American Medical SystemsInc. They had thelarge percentage of the market share for these particular products.

Is It Possible To Remove Transvaginal Mesh Device?

It is true that many times the mesh has been in the body for more than 30 days it is very difficult to be removed. Many other womenhave had multiple procedures trying to remove the mesh. So that’s one of most challenging aspects of this public health problem is that once the meshesimplanted it can be difficult to impossibleto remove the mesh.

How can I found out which company manufactured the mesh that I have been implanted with?

There are number of ways you can do that.You can call the physician who implanted the device and ask what device was used. Also, you can get a copy of the operative reportorwhat we call “the sticker page” which indicates the product that wasusedin the medical records and through either those two ways you can find out what device was implanted.