SEPTEMBER 16, 2011 - Editors Note: I attended the Food and Drug Administration expert panel convened on September 8 & 9, 2011 to listen to patients and industry as well as surgeons who use pelvic mesh to treat incontinence and pelvic floor weakness in women and hernias in men. All of the injured patients were articulate, sincere, and injured. When they spoke the room grew quiet and everyone appeared to be listening. Jerry Maassen helped his wife to the podium to speak. He said he accompanies her to doctor appointments. He appeared very attentive and the Maassens seemed like very nice people, the sort of folks you want for a neighbor or a relative. They did not seem like the type of people who would stand up in front of a panel of strangers and talk about incontinence, intercourse, or the nightmare of pelvic mesh, but they did. Here is Diane's FDA Presentation 9/9/11

Diane Maassen

AMS S.P.A.R.C. Bladder Sling Surgery

October 2007

Good morning. I am Diane Maassen and this is my husband Jerry. Thank you to the panel for allowing us to address you today.

In 2005, we were living a very active retirement in Las Vegas, Nevada. I began having a leakage problem when I coughed, sneezed etc. so I went to see urologist in Las Vegas, and he suggested trying different medications such as Detrol, Ditropan, & Vesicare.

Well I tried them all, and after taking these medications for many months none of them seem to help. He then suggested that I have a sling inserted in my vagina to hold up my bladder. He said it was less invasive than customary bladder surgery.

H e sent me home with a VHS video tape to watch on the S.P.A.R.C. sling manufactured by the American Medical Systems (AMS), and the ladies on the video seem to be satisfied with the results.

But the video did not explain or caution against any serious dangers or risks associated by having this product inserted vaginally.

The doctor scheduled the surgery for Oct. 16th 2007. The procedure was done as an outpatient day surgery. I was sent home after surgery with an inserted catheter and was told by the doctor that I should recover in 2-3 weeks.

Well, I didn’t recover in 2-3 weeks, it took me 5 months to just get out of bed. My body rejected the S.P.A.R.C. sling from day one.

I have had nothing but problems since I had the surgery. I spent days & days in that bed with horrific pelvic and stomach pain. I then became incontinent and could not fully empty my bladder, that caused me to have numerous urinary tract infections over the next 4 years. My husband & I have not been able to have intercourse since the surgery because it is too painful.

As time went on, the pelvic pain continued and I developed more bowel problems. I was going to the bathroom about 20-25 times a day. In Oct. 2008, after being so depressed from constant pain & suffering, my husband and I decided to move from Las Vegas back to Texas to be with our 3 children & 4 grandchildren.

My problems still continued after the move to Texas. My bowel problems became worse, so I went see a gastroenterologist in Arlington, TX. He then performed a colonoscopy which was negative for any type of cancer, and ordered a cat scan of my stomach which showed a large mass in the area of my left kidney. Because of the cat scan findings & ongoing urinary tract infections, he then referred me to a special urologist.

After the consultation & examination by this urologist, she referred me to another colleague of hers who specializes in female stress incontinence. After several tests over several weeks, he said I needed surgery to repair the sling by trying to loosen it up.

My husband & I asked him about the mass that showed up on the cat scan, so he sent me to another urologist who specializes in kidneys only.

At the consultation with the kidney specialist, he had a large TV screen in his office & wanted my husband & I to look at the cat scan with him. We were stunned & scared at what we were watching on the TV screen. It showed that my left kidney had become so large & hydronephrotic, that it had pushed all of my organs to the right side of my stomach. The doctor said that he needed to perform surgery right away to remove the kidney.

On June 11th, 2010, I had 2 surgeries in one day with 2 different urologists. One performed the 1st surgery which involved cutting out part of the sling to loosen it up. Then the kidney specialist performed the 2nd surgery which involved the removal of my left kidney, and the doctor said it was the size of a soccer ball. He had to remove 3 liters of fluid before he could remove the kidney.

I did recover from these surgeries after a painful post-op process, but I still have frequent urination problems. I am in the bathroom around 12-15 times a day & still have to wear pads constantly for leakage, as well as having continuing bowel problems.

I just had my bladder tested again on August 19th at my doctors office, and he said my sling & bladder is still a problem.

He prescribed some new medication, & if that doesn’t work, he said I will either need a 3rd surgery on the sling, or a type of pacemaker product to control the bladder. He also told us while we were there, that he is convinced that the sling caused me to lose my left kidney.

I want to know now - What do I do?

I didn’t have any of these problems before the sling was inserted.

I have now lost a vital major organ.

I am very angry about what I had to go thru for the past 5 years. I know I will continue to go thru many medical problems in the future, & I have lost all quality of life for the last 5 years.

So I ask you the Panel & the FDA to prohibit any of these devices NOW so that more perfectly healthy women will not end up going thru this NIGHTMARE!!!!

Thank you for listening!