Sunday, October 2, 2011

Women Used as Guinea Pigs

Every woman that has had a difficult vaginal delivery, or several, is bound to find that her bladder does not behave the same way it did prior to the pregnancy and delivery.  Kegel exercises are helpful to strengthen the abdominal muscles and over time, the expectation is that bladder control is ...well... under control.  A surgical procedure involving the permanent suturing of a mesh to the vaginal walls was designed to prevent bladder incontinence and other issues (Pelvic Organ Prolapse or POP). 

What the Heck is this thing?
The transvaginal mesh procedure is a technique that allows surgeons to stitch a mesh into a woman's vagina to help with incontinence that is typical of difficult deliveries or just something that happens as women age.  It is not uncommon to experience loss of muscle control and unpredictable incontinence after a difficult delivery or as we age and women find they need relief in order to continue living their lives to the fullest and not be subjected to constant embarrassment.  For some women, this is not just and inconvenience, but a smelly issue that precludes them from joining in activities and outings with the people they love.  For some, going out to dinner requires more preparation and vigilance than the outing is worth, and visiting relatives across the country is out of the question.

Besides medication, exercises and less invasive methods, there is the aforementioned surgical procedure in which a mesh is mesh is adhered to the vaginal walls to provide support.  The intent is to reinforce the lining and walls to prevent further collapse and hold in place everything that is collapsing, tilting or protruding.  Problem solved, right?

Who does this procedure?
One would think a surgeon with vast experience would, but according to the reports we have been reading, anyone with a medical degree can easily perform the procedure.  A General Practitioner could do it if so inclined. There is no law against him doing so, all he needs is patient consent.

Yes, well, as far as the manufacturer was concerned, getting this thing to market was the only priority.  They clearly stated to the FDA that any doctor could do the procedure and that it was a very easy process.  Also, the manufacturers never conducted any trials to determine benefit, side effects or long-term damage.

Say What?
Seriously, the FDA approved this thing without trials.

What Happened?
The stupid thing melds/bonds/meshes with the lining of the vagina.  Causes - get this...- persistent urinary track infections that are painful and other organs to protrude, which is exactly what this thing is suppose to prevent.  In addition, it causes painful intercourse and, as reported by the patients, chronic painful urination.  The last thing we heard was that in many cases, this mesh has melded so well with the interior walls that it becomes impossible to remove.  Permanent scarring and cramping are common.

What Else?
If that is not enough, many of the women have to take sedatives in order to bear the painful urination and chronic pain.  The lining of the vagina becomes thin and degrades and there is no repair method.  This is a permanent situation rife for additional health issues to come in the near future.   There are other complications that are inherent during the surgical attachment and should not be minimized: The possibility of hitting the bladder and perforating anything on the other side of the lining is huge.  This includes the bladder. Pelvic hemorrhaging is also common.

From the FDA Website:
From 2008 – 2010, the most frequent complications reported to the FDA for surgical mesh devices for POP repair include mesh erosion through the vagina (also called exposure, extrusion or protrusion), pain, infection, bleeding, pain during sexual intercourse (dyspareunia), organ perforation, and urinary problems. There were also reports of recurrent prolapse, neuro-muscular problems, vaginal scarring/shrinkage, and emotional problems. Many of these complications require additional intervention, including medical or surgical treatment and hospitalization.
Are These Meshes Still on the Market?
Yes. Even though the FDA allowed this product to market without medical trials, they have allowed it to stay on the market with a warning that there have been complications and that doctors should take a course/class/training prior to performing the surgical procedure.  For more information I am directing you to WebMD and urge you to read the comments at the bottom of their article.  They are from real women who have had this surgical implant.

There are lawsuits and a possible reclassification by the FDA for the products, but it is obvious that the companies involved are not eager to see the classification changed to high-risk, or the FDA willing to admit openly that approving these procedures without clinical trials was a huge mistake.  They may not have a choice since this subject is out in the open and many more outlets will begin talking about it in the upcoming days.

Why Are We Talking About this?
Because you need to know. We all do.  In addition, we need to be aware of the intrinsic connection between the FDA and former executives from the pharmaceutical companies.  There have been times that this agency is nothing more than a revolving door between the private sector and the government and this is not necessarily a good thing for patients.  

You, me and the guy down the street, need to do our due diligence and examine results of  procedures and drugs as reported by other patients and the results of medical trials. If none are done, you may want to consider not being the guinea pig, or if there are trials asking for women only, you may want to consider being a pioneer.  Of course, it all depends on your situation and level of comfort.

Personal Opinion
What bothers me the most is reading comments from young, and previously healthy, women who have been dismissed as being lunatics.  As women, mothers, daughters and just plain, ole human beings, don't we deserve to have clinical trials and medications done exclusively for women? - Heart, and many other,  medications are given to women routinely but they have only been tested on men in clinical trials.  It should not be surprising that women don't respond to these drugs in the same manner as men do and many have the opposite intended effect.  In short, what is effective for a man, may or may not work for a more complex and understudied system as a woman's body.

What Can Women Do? 
Women, and the men who love them, need to become proactive in understanding what is being prescribed, why it is being prescribed and if there have been clinical trials involving women and understand those results.  If the trials involved both genders with a success rate of 80 percent, find out how much of that percentage were women, because if 70 percent success rate was only for the men, this may not be for you or the woman you love.

Get a second and third opinion and don't get them from the same place.  Furthermore, outweigh the current situation and perceived benefits before considering any type of procedure.  Many of us can lead normal lives through pain management that can be a combination of lifestyle changes, holistic approaches and tried and true pharmaceuticals.   For those of us who require more invasive procedures, jumping into it should only be done if there is no time to spare.  Most of us can, and should, take a few steps back and examine the situation from all angles before we decide to permanently insert foreign objects into our bodies.

I wish you health and PEACE 

Related Articles:
The Naked Doctor
The Naked Patient
The Naked Spouse

Image: Stuart Miles /


Amanda aka LibrlOkie77 said...

Thank You for the information. This is quite disturbing. The thought of putting something in your body that no one has tested is frightening.

You raise a very good point, before having a procedure research the procedure. Just because one Doctor says it is a good idea, another Doctor might have a less invasive solution.

Of the subject a bit. My Husband's Grandmother had back surgery many years ago. She is in a lot pain now so they where looking for a Neurologist to see. Many of the Neurologists would not see her because of the Doctor that operated on her back. After research, they discovered the Doctor that operated on her no longer had a license and was being sued. My point is that you should do as much research as possible on the Doctor that is going to cut you open.

My one criticism of your blog, not all Doctors are male. :-)

Thank You Olivia!

Love & Peace

Olivia Emisar said...

Hi Amanda,

Sorry to hear about your grandmother. It is possible that the fact that her former doctor is being sued plays a role in doctors treating her, but don't discount that back surgery is a difficult process and what was done to her may not be an easy fix. Her age may also be a factor.

About the criticism: I re-read what I wrote & can't find where I stated about all doctors being male. If u can point that out to me, I'll gladly correct it. No offense taken, we live, we learn, we evolve and I thank you for your comments.


BlueTrooth said...

Well hey there! Interesting example of a product making it to market without thorough testing. In my own experience, I've been prescribed a few drugs that I had to make my own decision regarding continued use or even starting them. My Doctor is an Angel, but she's also human. Before she went to electronic record-keeping (a result of "Obamacare"), my follow-ups would routinely consist of 20-30 minutes of review (going over the handwritten files) and then the "how's everything going?" followed by the refill prescriptions and maybe a new one. One drug was prescribed that included a warning regarding heart problems. I was kind of surprised my Doctor would take that risk with MY heart. I made my own decision to not begin the regimen. The drug? Avandia. The next visit, the topic of Avandia never really came up and I think I just briefly mentioned I didn't think the symptoms were worth another prescription. About 6 months later, Avandia was in the news for causing heart attacks. The basic point being that as a patient, it's important to exercise a healthy skepticism. I also established a goal long ago of keeping my "meds" to a minimum. I know some of my friends that tend to brag about how many different pills they take as if it's proof they are a "miracle of science" or something. It may be a miracle they haven't had serious complications.

Anonymous said...

Is this procedure approved in other countries?

Everything about it revolts and I think i'd prefer wear incontinence pads for the rest of my life than get it done.

Anyway, my new sound bite: todays new drug advertising campaign is tomorrows class action law suit.

Marie @re67u

Olivia Emisar said...

Hi Marie,

Yes, it was approved in other countries. Canada is cautioning against it and there was a study in Europe I read through. Looks like lawsuits are already in process, so you are right about your new sound bite. :-)