Your Turn: After the Ethicon decision

Jane Akre
February 19, 2014

This woman who will go unnamed has written her thoughts about the Charleston decision regarding the TVT implant and the judge's decision to cut short a jury decision and to make the decision on his own. She admits she was frustrated and it was 3 am but she felt better afterward. As the only reporter who sat in the courtroom all week, I'm sorry that this case ended this way and sitting in that courtroom had great faith that the jury might have rendered a decision in the plaintiff's favor. Sadly they never got to issue their feelings. Here are her words:

Anonymous woman, WikiCommons

Anonymous woman, WikiCommons

Hello all,

I have written to the FDA several times. I have filled out the 3500 form. The MAUDE database is a joke. I have been severely injured by a Boston Scientific Obtryx. This is a sling for stress urinary incontinence. My incontinence is much worse following the surgery and I've had so many painful complications, surgeries, botox shots, etc. I have watched the news (and lack of news) for any indication of follow through on the part of the FDA. It isn't happening. The FDA put out a requirement that the pharmaceuticals do a 3 year follow-up study on their transvaginal mesh products and gave them a deadline date. They haven't done the studies, and in some cases just pulled the product off the market with no consequences.

My life and the lives of so many others have been destroyed and we are being ignored by our own government officials. I tried to write to the congressmen who oversee the FDA. I do not live in the right state to get their attention, all of them refused to hear from me (I am not their constituent). The fact that the FDA decided not to investigate the SUI mesh is confusing and alarming. The product that was implanted in me was cleared based on a "predicate" device that was recalled for excessive harm. I had a Dr. who did a partial removal tell me "I don't consider the FDA a reliable source and I do not report any complications to them." Apparently in the US most Dr.'s do not report any revision surgeries or complications from these products. Even after the FDA put out a letter asking for complications to be reported.

I tried to look up complications that have been reported on the Boston Scientific Obtryx in the MAUDE database and got hundreds of pages of identical reports with no details. The fact that the media is ignoring the largest MDL in the history of the United States covering several state courts is mind boggling. Why are these companies not being investigated for criminal negligence, for causing bodily harm and even death to so many? Why are these products still being sold and implanted every day? Dr. Raz's nurse (UCLA, CA. Dr. Raz is a leader in mesh removals and complications) told me that the wait is so long for surgery (hopefully to remedy 9 pain on a daily basis) because they are still implanting this every day and they are seeing new complications daily-the list is growing for those of us who are losing our lives to this "minimally invasive" product.

I do not think it is going too far to say that you are clearing products that are actually allowing United States Citizens to be tortured on a daily basis. In my case water boarding would be more acceptable.

I have continual genital pain, pelvic pain and spasms. I have to take about 25 drugs on a daily basis just to get through each day. All this because I leaked urine when I coughed or sneezed. Please DO SOMETHING! STOP the senseless maiming of US citizens. We are not just numbers on a piece of paper. There is a big difference between claiming that a "minimally invasive" product is even 94% effective for curing incontinence than claiming that it causes severe harm, mutilation and even death when it goes wrong (6% of the time according to the companies, and they deny this happens-they admit it doesn't cure incontinence 6% of the time).

A lawyer for the defense of Ethicon (a subsidiary of J&J) just stated in a WV court on Thursday (February 13, 2014) that their SUI product "is the gold standard of the industry." There are many studies that show a much higher complication rate than 6%. The bottom line is money. They are making billions and are getting away with it. Dr.'s are making a lot of money and they are also getting away with it. The FDA looks the other way and allows this travesty to occur. I have never smoked, and I don't drink. What has happened to me is so much worse than what is caused by smoking and excessive drinking. And ironically if I decided to drink and drive and hurt someone I'd pay the price. But pharmaceutical companies don't have to worry about what they decide to sell and put into our bodies, even if it causes death to occur, they are above the law.

Our country is in great need of people who do their jobs with accountability, integrity, honesty, and pride. Who are not bought off with money and who do not cave into political pressure. The only thing that allows evil to prevail is for good men (women) to do nothing. Evil is prevailing. Please save other women from going through this and stand up and DO SOMETHING, MAKE A DIFFERENCE.

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