February 3, 2012.
That was the day that Deb Contestabile says her health took a downturn from which she has still not recovered.
The 46-year-old mother of two boys led a predictable and comfortable life with her husband of almost 22 years who owns a machine shop.
They have busy lives with the two boys in sports and her full-time job as an administrative assistant at the University of Rochester in Rochester, New York. Deb was about to transfer to another department and thought, why not take time first to fix this small, inconvenient problem of incontinence. She believed it would be minor surgery to treat a “somewhat embarrassing problem,” and besides, Deb’s friend had had the same procedure six months earlier and raved about no longer having to wear pads or worry about sneezing.
Deb wanted to start the new job free and clear of the problem and not need to take time off once in her new position.
She went to the same urologist as her friend.
“I had never gone to him before. He was abrupt with zero communication, like he was in a big hurry, he came in and left. I didn’t worry about that because my friend recommended him” she says.
Was she told about complications? In other words, fully informed so she could give her consent to the surgery?
“I didn’t research a lot which is not like me. I normally research and am skeptical, but I thought this was just minor so I didn’t really think too much about it. He gave me a pamphlet which didn't say much. He seemed more concerned that my insurance would qualify me to have it.”
The urologist told Deb the time off would depend since everyone is different. The surgery was scheduled for a Friday and she would go home the same day with a catheter which would allow her to empty her bladder through a tube. She’d come back Saturday to have the catheter removed.
With those assurances, Deb didn’t even take Monday off in preparation for the surgery.
“After the surgery, I found out I shouldn’t be driving for two weeks. The pre-surgery prep at the hospital just seemed like a lot of paperwork, talking about the hospital and where to go. I knew any surgery has risks, but I had no idea how serious mesh complications could be, how common they were, or how difficult they were to fix."
“I thought, if there was a problem, they’re going to fix it.”
Deb C. and her husband, Kevin
So on February 3 of this year, Deb Contestabile had the American Medical Systems, Monarc TOT, transobturator tape (TOT) sling implanted to support the urethra. Using three small incisions, called “minimally invasive” the synthetic polypropylene mesh is pulled into place through two groin incisions, the obturator membrane and around the ischiopubic ramus region.
The procedure is said to be safer than a “blind” needle passage and does not have to pass through the abdominal wall like traditional slings. AMS has more on the mesh on its website (here).
Transobturator surgery, Miklos and Moore
YouTube has a video of the procedure * Warning very disturbing images (here).
Here is a animation from AMS *Warning disturbing images (here) .
She says it’s been all downhill since.
“I had problems right away. I felt terrible that night. I was so sore I could hardly move, I was bleeding bad. I called my friend that evening and asked her, ‘Were you like this? I can’t move?” Then I called the surgeon’s after hours emergency care. An on-call doctor returned my call and told me I was okay to wait until my appointment the next day to be seen.”
Deb was scheduled to come in Saturday morning to have the catheter removed, but when she got there, the clinic was closed.
“I was hobbling around with my catheter and the clinic was closed! I’m in pain right? There was a gentleman there also waiting and I’m on my cell phone calling the after hours care again, what the heck?”
Eventually a nurse showed up, apologizing profusely. She removed the catheter from Deb and told her, “You’re fine.” Still, no doctor showed up. Deb was told everybody is different and if the bleeding gets worse, call the doctor.
A friend drove Deb to and from work for a couple of weeks and Deb says she felt the stitches. She was still in a lot of pain and thought “Maybe I’m just taking longer to heal.” Two weeks after her surgery during the follow up she told the surgeon she could still feel the stitches and was in a lot of pain.
Deb and Cleo
“He didn’t even examine me. I asked him what happened on my appointment the day after my surgery when the office was closed. He acted as if he didn’t know anything. I was concerned by the amount of pain and how hard it was to walk but he assured me everybody is different. “Give it time”, he said, and quickly ended the appointment. I called my friend right after, ‘did he examine you?’ I was dumbfounded. I couldn’t believe it.”
Deb was now hobbling around with pain in the groin, left leg and hip area. It grew worse and worse until she felt her leg giving out.
“I started getting shooting pain in my left groin/leg whenever I walked any distance. The pain stems from what I now know is my obturator muscle area, and then sort of goes out and down my leg. That same pain just kept getting worse. I started limping more and more, and by July it got so bad I was using a cane or a crutch.”
Today she can’t walk without using a crutch and regular pain medication.
At work, Deb attempted to hide the fact she felt sharp pain, but the limp was harder to hide. Thinking she might need to get in better shape she tried to walk during her lunch hour, but this just increased her pain and soon any distance at all was impossible.
A visit to her regular doctor at the end of April yielded no answers. She was told she might have bursitis and given anti-inflammatory medication. Then, at her second follow-up with the urologist in May she pointed to the area where she was experiencing pain. That couldn’t be linked to the sling surgery, she was told.
But that was not enough of an answer for Deb. This pain didn’t just coincidentally start after her mesh surgery.
ROUND OF DOCTORS
By April Deb found herself on the circuit of doctor visits that so many mesh women experience trying to find out why she felt so bad. She visited the original surgeon in May for her second follow-up, and told him she was limping. By this time the internet had yielded some suggestions she might not be fine and that her sudden onset of symptoms since the mesh surgery might be related.
“He immediately said it’s not from the surgery. ‘Everything we did is over here in the abdomen’ he pointed, 'you wouldn’t be having pain in the leg or hip area’. I said, ‘yeah, but it hurts right here’, pointing to what I know now is the obturator muscle, and said ‘the pain starts here then shoots out and down my leg’. He still looked me in the eye and said, ‘That’s not related’ and told me I should go to a chiropractor,” Deb says today.
Still, she received no internal exam in fact, the surgeon never examined her after his surgery. Later his notes would say she complained of pain “far away from the incision area” and she had no vaginal pain.
Her primary doctor gave her anti-inflammatory drugs and told her to go to an orthopedic doctor, who said she had a mild hip dysplasia in her left hip. All the pain was from that and not the mesh she was told. She had x-rays, an MRI done, received a cortisone hip injection and was referred to another orthopedic specialist. She was too young for a hip replacement but she might be a candidate for a hip osteotomy where bone is cut to change its alignment before it’s put back in the pelvic area. This is major and rare surgery with a long recovery time. She would have to drive or fly to a special clinic in Boston that specialized in that type of surgery.
“They were more willing to discuss that than mesh removal,” said Deb who still suspected her shooting pain must be mesh-related.
Finally, the first confirmation came from a Rochester area urogynecologist that Deb sought out independently and waited months to see. This doctor suggested her pain could be mesh-related, though she’d never seen that complication before. “You’re the first one,” she was told, as so many mesh-injured women hear. The doctor didn’t blame Deb for wanting it out and told her a partial removal might be possible but a total removal wasn’t possible.
Deb and family
Deb’s online reading told her partial removals often left more women in excruciating pain and in need of additional surgeries. Research yielded more information. The transobturator tape had been known to pinch the obturator nerve and cause groin and leg pain. She watched a video of surgeons doing a Monarc Sling surgery and saw the kit they used. They take a steel hook through the obturator muscle.
“Once I saw that, I thought how could he look me in the eye and say that is not related?” Deb says. Her next move was to call the clinic of Dr. Shlomo Raz at UCLA, hoping for a cancellation appointment. Regarded as the premier mesh removal doctor in the world who sees hundreds of women every month who fly into the clinic from around the world to have their vaginal mesh removed, Deb kept calling and finally got an opening in August.
His comfortable manner made her feel she made the right decision. The Monarc Sling is known to cause the kind of pain you’re describing, she was told. His exam revealed that part of the mesh was thicker than 1 centimeter so it may have bunched up or was shrinking and jabbing her obturator muscle causing spasms. His opinion was to have the entire sling removed, not a partial removal. She might experience an 80 percent chance of recovery and her incontinence may not come back if the urethra stays in place. If it does come back, he told her she could come back in a few months and they could make another sling using her own tissue – no mesh.
“He seemed to know exactly what I was talking out,” she told MDND. Finally some good news; the bad news –Dr. Raz is so booked up, he couldn’t operate until January.
Insurance will cover the operation, but not the travel and hotel.
“Every day I wonder how I’m going to make it until January,” Deb says but she adds she is one of the lucky ones, not only to have insurance, but a supportive husband and two kids who can do a lot for themselves.
“I can’t keep up with anything -work, laundry, dinner, anything. The other day my 15-year-old forgot his homework and called me to ask if I could bring it to school. I said, okay. Then, I thought, ‘wait. Is there handicapped parking there? How close?’ I pictured the huge steps up the front of school. I started crying, I can’t even bring my kid his homework.
“My younger son said, “I don’t like you like this.” He wasn’t being mean. I told him I don’t like me like this either. I’ve had a lot of friends look at me funny when we get together and see me with the cane or crutch and say things like, ‘I’m sorry, I can’t get used to seeing you like this. It’s so not you’. My husband’s been a saint through this. I don’t know what I’d do without him.”
WAITING FOR SURGERY
Deb says she is not embarrassed to tell anyone about what she’s experienced and feels like she needs to warn people. Friends are shocked that she is hobbling with the aid of a crutch at age 46. She has joined the online community of Mesh Medical Device News Desk, the same group on Facebook page, TVT No, Medical Mesh Legal Support and other sites, and has talked to hundreds of other women who are suffering, some in silence.
One women has posted a video (here) on YouTube of her travails getting into and out of a car. Deb says that's how she's getting.
Deb plans to let all of the doctors who consulted her know what the real cause of her pain was, after her surgery. She wonders if they were entirely unaware of the two Safety Notifications from the U.S. Food and Drug Administration, or if they just didn’t think they applied to her? The first in 2008 said the thousands of complications such as mesh erosion, perforation of organs, pain and systemic changes. The second mores strongly worded in July 2011, said complications are “not rare” and questioned whether the use of mesh was worth the risk.
While these warnings involve synthetic mesh used for pelvic organ prolapse (POP), the FDA has not issued a similar warning for the same mesh used for incontinence (SUI).
“The FDA continues to evaluate the effects of using surgical mesh to repair SUI and will communicate these findings at a later date,” the agency said in July 2011.
So far there has been no update, but an expert panel convened in September of last year seemed to agree that incontinence mesh did not pose the same dangers. See the FDA July 2011 warning here.
As a result, Deb wonders if this is why she wasn’t fully warned of the risks, and vented her frustration in an article she posted in Facebook as well as MDND called, “Mesh: Definitely risky for POP, but for SUI? Eh? It might be okay still, right?"
Finding a lawyer willing to take a case of SUI mesh injured woman sounds like another hassle to Deb that she’s not sure she wants to take on currently. At the moment, Deb, like other women injured by synthetic mesh used to treat SUI, is not represented.
“Perhaps one of my greatest challenges now is waiting. My condition only gets worse. Everything is getting harder and harder, emotionally now, as well as physically. To me, what I'm going through seems like a little personal hell. I'm normally a strong, independent woman. I hate missing my children's events... not being able to do things like walk my dog. I loved long walks through the woods with my kids and dog but that’s something I haven’t been able to do lately. I hope that my waiting and going to Dr. Raz will save me a lot of time and pain in the future.
“I had this surgery so I could be more active and not have to deal with the minor problem of incontinence, but now I can’t even walk. Had I known one tenth of what I now know about mesh, I never would have done this.” ##
Deb C. 46 years old
Mesh: Monarc TOT transobturator tape, American Medical System to treat SUI
Implanted: Feb 3, 2012
Explanted: Not yet, waiting for January 2013 removal surgery, Dr. Shlomo Raz, UCLA
File FDA report: yes