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Smith vs. Johnson & Johnson Case #11-60624 

The Woman Behind the Case Tells Her Story (Part 1)

ABDOMINAL SACRAL COLPOPEXY,

Better, Safer Than Trans-vaginal Mesh?

By Deborah Lane Smith

 

      She woke up from a nightmare in which she saw herself in a coffin. She was crying uncontrollably and screaming. My father consoled her as best he could. “It’s just a dream, Baby. And it’s just a simple hysterectomy. Women do it all the time. What could possibly go wrong?” Well, the answer to that is short and sweet…a heck of a lot.

 

      My mother, 32 at the time, never came home from the hospital. She bled to death on a warm spring night in June of 1972. They called it DIC. She began hemorrhaging during the hysterectomy and even though blood donors poured in by the dozens nothing could be done to save her.

 

     Daddy never did recover. He remarried twice but each spring he stomped through the creeks and swamps to gather the pink honeysuckles she loved…He brought them to her just like he always had but there was no joy in it…..our lives were forever changed and not for the better.

 

     I tell people, we went from middle-class to white trash overnight. That’s the truth. See, Daddy never got over losing Mama and what remained of the hard-working, tough-as-nails and fun-loving man Mama had known and loved was a broken, bitter shell.  My 4 sisters and I, ranging from age 3-13, pretty much became orphans and had to learn to make it on our own at a very tender age. We had very little guidance and the worst possible role models. So, when I say we had to learn everything the hard way….I’m not quoting clichés and when I say we had to claw our way up and out of the bottom of the barrel….you can take my word for it. We were no longer the apple of anyone’s eye. We had become a burden to the man who used to sing and play and love us unconditionally and our once admired and highly respected Daddy… had become a mean drunk.

 

     My name is Deborah Smith. I’m the oldest of the 5 girls mentioned above and I just lost my lawsuit: Smith vs. Johnson & Johnson; case #11-60624. My husband and I filed suit for severe injuries from Mersilene mesh which was implanted during an abdominal sacral colpopexy to correct a failed hysterectomy. I’ve become aware that the FDA did not include abdominal placement of mesh in its warning in July 2011 but I’m living proof that it should have. Some attorneys along with some doctors propose abdominal sacral colpopexy is a better, safer alternative than transvaginal mesh. I plan to put an end to that myth.    

 

     In December of 2001, at 42 years old, I had a hysterectomy for break-through bleeding. I didn’t realize at the time that it was unnecessary, as so many are. See, I grew up thinking that a hysterectomy was part of the natural course of events in a woman’s life…you know, first the menstrual cycle, then children and eventually,  a hysterectomy and menopause. Needless to say, I was terrified because of Mama’s horrific hysterectomy experience but when I woke up following surgery…all I could think of was that I’d made it. I was going to be ok.

 

      Well, the hysterectomy failed six weeks later while my husband and I were at a social gathering. I stood up and felt something fall inside me. I called Dr Mills, the ob-gyn who had performed the surgery and his first response was ‘that’s impossible!!’ Well, that’s what I thought too! We decided to meet at the ER. He examined me and declared that everything was normal! I was baffled until I realized that I was lying down. So, I stood up and told the doctor “now examine me” and he did. His words were “oh! OH!!” I said, “Now Dr Mills I don’t know about everyone else but THAT is NOT normal for me.”

 

     Until that point I was a vibrant, healthy, independent and sexually active mother of two. I was capable of anything I set my mind to and proud of it. Even Dr Mills couldn’t believe what had happened because I was so healthy, young and had great muscle tone. His actual words! He apologized profusely and told me there were other things he could have done to prevent this if he’d suspected this outcome. He explained that my vaginal apex had dehisced and prolapsed along with a portion of my small intestine which fell into the vagina. I don’t mind telling you I was scared to death.

 

     He suggested a urogynecologist he knew and made an appointment. This urogyno/surgeon treated me like a bug under a glass. He called in nurses and staff to come take a look. I was humiliated and left with no intention of ever walking back in his office. 

 

     In April of 2002, Dr Barksdale performed an abdominal sacral-colpopexy. By then, I was a mess. The plan was to go in abdominally and attach my vagina back in place with a mesh. This would be a permanent fix. If there were other options, no one told me but at the time I was just so relieved. I’d never even heard of such a thing and I was very grateful that IF this could happen to a woman, then at least, they could fix it. But that was before the Mersilene mesh became infected and had to be removed.

 

     Approximately a year and ½ following the sacral-colpopexy surgery, I began to have major complications:  pain and infections which became progressively worse and then, bleeding.  After seeing two other doctors and taking several rounds of antibiotics, a thorough exam was done and it was discovered that I had “mesh erosion”. “Mesh erosion”? What?

 

     I went back to Dr Barksdale, who did a brief exam. The look on his face said it all; it was kind of a green, pasty look. He told me the mesh was infected and had to come out. I asked what he meant. I thought the Mersilene mesh was permanent. I asked what would keep my vagina in place if they removed it. There were no answers. He said that he would have a team of surgeons in the OR, including a cholorectal surgeon. When asked why, he said that it was likely I would end up with a colostomy….for life, due to all the scar tissue.  I was shell-shocked. I cried all the way home. I call Dr Mills. He thought Dr Barksdale was just giving me a worst case scenario…but he didn’t see the look on the man’s face. I tried to speak with Barksdale again but my calls weren’t welcome.

 

     During this time, we invested in a computer. I began to learn how to use it and started researching the mesh removal surgery and seeking experienced surgeons. What I read terrified me to the point that I made out my will.

 

     I came across a Dr. Miklos. I e-mailed him and he called me very early the next morning and talked to me for a long time. So I made an appt and my husband and I drove from Mississippi to Atlanta, Georgia to see him. I came prepared with questions, my medical records and a recent CT, which he never even looked at. He assured us that he’d done 1000s of these mesh related cases and removals. His opinion was, since a sinus tract formation had developed, the mesh would just pop out and because he was doing it laparoscopically, I would be back on my feet and home in a week. (I would later read a study by Miklos where he had done five (5) mesh removals at that point in time.)

 

     Well, nothing went as planned. I was in extended recovery for 3 days. My husband called in the family. When I came to I was in a room. I wasn’t allowed to eat or drink. I was bleeding and afraid. Dr Miklos assured me that I was going to be fine and I believed him… until I ate. See, during surgery, Miklos had perforated my rectum and all I consumed came out through my vagina. Later, he explained to my family that there were pus pockets and so much scar tissue; they had to literally chip it away. He said they removed as much of the mesh as they could, piece by tiny piece, but were unable to remove all of it. 

 

     My abdomen began swelling. I had peritonitis. I had to undergo a colostomy placement. This did not go well due to the swelling and another perforation. I remained in ICU for weeks hooked to an NG tube and every kind of machine imaginable. My abdomen actually burst open where the colostomy surgery incision was and I had to be wheeled back in for another procedure. There was talk of yet, another surgery, but new doctors arrived with a new approach to tackle the Illeus? issues. The following week I was sent home. So, nearly 6 weeks hospital stay, most of it in ICU, for a ‘simple’ mesh removal surgery.

 

     There were months of recovery for this ‘simple’ surgery with more corrective surgeries to follow and of course, additional recovery time; new wounds to pack and wound vacs and home health. It’s been a vicious cycle. My husband and I learned to do things we never dreamed of.

 

     The first corrective surgery was a recto-vaginal fistula repair to fix the rectal perforation. Then, finally they took down the colostomy bag but the recoveries were neither short, simple or painless. The only thing left to do was to repair the huge hernia. My abdomen was so large I looked 12 months pregnant but with none of the usual expectations. Once again, I started seeing surgeons and they all wanted to use more synthetic mesh!!! Well, that wasn’t going to happen and I wondered if they were crazy or they thought I was….just sayin’.

 

Eventually, I learned about Alloderm, a human cadaver product used instead of mesh.  I found a surgeon who had experience using it and made an appointment. Did you know that Alloderm doesn’t hold up real well? It’s also prone to infections. This recovery and the many follow-up procedures was another nightmare. As a result, I have multiple hernias and infections that are causing sinus tracts.  I’m afraid to let another surgeon touch me and yet, I know, the day will come when I’ll have to. The last surgeon said that until or unless we get the infections cleared up, there will be no surgery. I can’t say I blame him. That’s my biggest fear; the embedded infections.  I am currently seeing an Infectious disease doctor to address this on-going complication.

 

     So, we have an abdominal mesh placement post hysterectomy surgical failure, followed by mesh erosion and removal of infected mesh, which resulted in perforation of the rectum, colostomy placement, illeus issues…and a 6 week hospital stay w/Home Health for months. Corrective surgeries include recto-vaginal fistula repair and eventual colostomy take-down, a hernia repair w/complications requiring many more months of HH, other surgeries, infections, recurrent hernias and on-going infection issues. I’m disabled and suffer varying degrees of chronic pain on a daily basis with no end in sight. So, “Dear Attorney”, PLEASE tell me how an abdominal placement of mesh is any safer than the transvaginal placement. I’d really like to know.

 

     Here’s what I do know. Synthetic mesh is designed to create scar tissue to hold it in place; which is horrific, in and of itself! Synthetic mesh can become infected and cannot be treated or SAFELY removed. Polymers used to manufacture mesh should NEVER be used in the human body; not temporarily, not permanently, not for any reason!!

 

So I ask you: how could the method or placement of said product make one damn bit of difference when it’s the chemical make-up of the product that is the problem? Just think about it!

 

      It’s too late for me and so many others. My life is essentially ruined; No more baseball, no more long walks, no more fishing or canoeing, no more work and no more sex….it’s over. But, the next generation is coming. I have grandchildren and I do not want this product used on any of them…not EVER.

 

     One other thing worth mentioning is that my case never went to trial. The manufacturers never had to look me in the eye. They never had to see what their product did to me or even give me a sincere apology. I feel the legal system let me down…but I’m not dead and that’s something to be grateful for… Right?

Well… it’s something.

 

     The point is as long as I draw a breath…it ain’t over.  I only hope I live long enough to see this product banned forever. I strongly believe that the use of this product will become a case in study for the manufacturing industry, for doctors, the FDA…and the legal field for many years to come. Each of you has a mother, a sister, a wife or daughter that could someday have this mesh implanted; or a father, brother or son who may need a hernia repair someday. Do NOT let it happen. Do Not allow one more person to fall victim to the agony so many others have to live with every day because of synthetic mesh. I want the people who work at those mesh manufacturing companies held accountable for the incredible pain and suffering I live with every day of my life!! I want them exposed and I want them stopped!! To them, it’s just money in the bank. To the victims like myself and so many others…it’s total madness.

 

     So, that’s my story in a nutshell. Life as I knew it is over and there’s no happy ending in sight, just my unending mesh mess. And as for those attorneys and those doctors who propose abdominal sacral colpopexy is a better, safer alternative than trans-vaginal mesh, what are you thinking?

 

 

Deborah Lane Smith

December 2, 2012

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