Sheri Ragan is playing the waiting game - waiting for a hospital in Ormond Beach, Florida to decide when and if it will take Medicaid so she can have an infected biologic mesh implant removed by the doctor of her choice. At 42, Ragan still doesn’t know how she ended up with six years of pelvic pain following an inguinal hernia repair, first with synthetic mesh, then biologic mesh made from cadaver skin cells following a hysterectomy she apparently didn’t need.
Here is her story:
“In May of 2006, I had bilateral inguinal hernia repair open technique. The surgical mesh used is a material made by Ethicon, a Johnson & Johnson Company, it's called Prolene Hernia System.
“A month later I was back in to see my surgeon with the same pain I’d felt since the hernia patch was put in. He told me I didn't have a recurrence and to get my ovaries checked out since the pain was coming from that area.
“I went to my gynecologist and after multiple tests she decided to do a full hysterectomy. The pathology report from my hysterectomy showed nothing. There was no evidence that I should have had a hysterectomy. My pain has not diminished since the hysterectomy.”
Ragan and her doctors thought either the Prolene hernia patch or the hysterectomy would have addressed her pain, but neither did. Her general surgeon in Saginaw, Michigan suggested she give it more time. When that didn’t work, he suggested a “little boost” in the form of some nerve blocks.
“I had two on the genital femoral nerve and one on the ilioinguinal nerve. The first one on the genital femoral nerve worked for almost 2 weeks. The block on the ilioinguinal nerve did not work at all. I got my operative reports it said at the time he put the mesh in he took out my ilioinguinal nerve. I didn’t know that. Imagine getting a nerve block for a nerve I didn’t have, and he had ordered it!”
Ragan was 36-years-old. She had a new grandson, grown children and pain that emanated from the incision site shooting down the leg which she describes “like electrical shocks”. Most days she was in a chair or in bed, unable to move or work. All of this for a hernia that she had never felt, but was diagnosed when she initially went to her doctor for some hip pain.
“They said the pain was nerve damage from what, they didn’t know. I brought it up to them about the mesh as the source of pain. I asked about the possibility of meshoma (chronic pain from mesh implant) and it balling up at the end. He said it couldn’t be the mesh, it’s effective, it’s hard to believe you are the one person in my career…I’ve never had this happen. When I brought up terms I had learned, that’s when he knew I knew something and he rushed me out of his office.”
Ragan says she kept digging deeper to find out more and her conversations with others told her she was not alone. Another woman in Saginaw had gone to the same doctor for a hernia repair, she also had complications following the synthetic mesh implant and is currently hospitalized with a bowel obstruction surgery. Her nephew had synthetic mesh implanted to treat a hernia and is still suffering complications. Yet another doctor, this one in Ann Arbor said he didn’t think it was the mesh. Sometimes you get chronic pain afterward, she was told. Live with it.
Ragan says she became more convinced that the pain she was experiencing was the same as others she read about who had the same experience following a mesh implant – the same story, the same pain. Once again, she returned to her gynecologist who did the hysterectomy and she called in another doctor to look for symptoms of any mesh complication in the groin area.
“He ended up assisting and taking out a dime piece of mesh that was poking through my peritoneal. When I went back for my six week checkup I asked about removing it all. He said ‘I know how to remove the mesh, am I going to do it? No, because I’m not going to fix someone else’s mistake.’ He wouldn’t tell me what it meant. I was ready to cry and give up,” she says.
Once again not deterred, Ragan had a plan. She would raise the funds she needed to see Dr. Bruce Ramshaw, recommended by hernia mesh injured patient advocate, Bruce Rosenberg. Dr. Ramshaw was in Missouri and charged about $12,000 to remove hernia mesh. Selling her household goods she failed to raise enough for the surgery. So she turned to Plan B – purchasing a vehicle, Ragan went to see a doctor in Dearborn, Michigan who had removed a friend’s synthetic hernia mesh. She drove from Saginaw to Dearborn, had the mesh removed as promised at the Oakwood Healthcare System. But the surgeon there replaced the synthetic mesh with a biologic material called Alloderm, made from harvested cadaver cells.
Ragan says she was on Cloud Nine for the first time in a long time. The doctor had removed her mesh and took pictures of it. You could clearly see it had balled up and was hard as a rock, she says. For the first time in a long time she was pain-free. Back in Saginaw, she participated in a Relay for Life cancer fundraising walk and enjoyed time with her grandson, Daniel, who she calls the pride and joy in her life.
Then the pain began again.
“It started going downhill and the pain came back slowly. I went back to the Dearborn doctor and he said well, since this one didn’t work out I can’t help you anymore. The day after that, I ended up in the hospital emergency room for a suicide attempt. I took too much medication. I just wanted to go to sleep. I was so devastated. I thought I can’t do this again. There was no indication what was causing the pain and he said I should start back on pain management again.. All I heard was blah, blah, blah, ‘the rest of your life.’ ”
By this time, Ragan was alone. Her husband had divorced her. One of her three children was not speaking to her, another was angry because she couldn’t attend her high school graduation. With nothing holding her back, she moved to Holiday, Florida to live with her sister and to move closer to Dr. Ramshaw, who had now moved to Halifax Medical Center in Ormond Beach.
“I was going to get him no matter what it took,” she says. Dr. Ramshaw has Ragan’s medical records and the hospital is now waiting to see if it will take Medicaid, the insurance she has with her supplemental SSI Disability, the disability she’s suffered since her initial prolene mesh repair.
“He tells me it isn’t 100 percent guaranteed and I understand that it will be my last resort. I’m in pain every day. If I walk too much and overdo it, there is a shooting pain inside of my legs, so I try to avoid that. I can’t sit up straight for a long period of time. I live close to a fishing hole and go there and sit back and relax. Other times I sit on the couch and play online or watch TV. There is not much I can do now.”
“I’m very mad, I don’t know who to trust anymore. There is nothing else that’s going to be in my body anymore, that’s for sure. What I don’t understanding is (her first mesh) it’s the same exact mesh used for vaginal prolapse. Why are the FDA warnings not for hernia patients like us? It’s hurting as many hernia patients as women for vaginal prolapse, there is a wider range of people because it effects both men and women.”
*Editors Note* Ms. Ragan had the AlloDerm biologic mesh put in after the Ethicon synthetic mesh was removed. Developed by LifeCell in 1994 to be used in burn care and later in plastic surgery, the human tissue implant comes from donated cadaver skin cells that are harvested and processed to form a skin graft. Biologic mesh was thought to be a safer alternative to those made from polypropylene, a petroleum-based product used in most synthetic mesh.
Problems arose in 2005 when LifeCell Corporation of Branchburg, New Jersey, had a lapse in internal quality processes after questions were raised about the donor documentation received from one tissue recovery organization.
That’s when the company issued a quiet, voluntary recall of its biologic mesh. The FDA notification is here.
Ragan’s Dallas attorney, Bill Curtis, says he has 40 to 50 of these cases and the complications arose when LifeCell’s sales reps promoted the off-label use of AlloDerm for internal use and hernia repair between the years 2002 and 2009.
“It sounds a little better than an artificial graft but if you’re going to stretch the mesh again to repair an overly stretch material, they reherniate and in the worst conditions cause infection,” he tells MDND. Additional surgeries often follow an AlloDerm implant along with abdominal pain, disfigurement, a recurrence of the hernia, abscess, infections which can be life-threatening, swelling, and discomfort.
AlloDerm is no longer recommended for hernia repair. #