Suffering in Silence: Mary Blanks Not Silent Anymore About Transvaginal Mesh Sling

“I’m a pretty smart cookie. I’ve tested genius, but trust me I’m at half capacity.”

So says 58-year-old Mary Blanks of Erie, Pennsylvania. The Methodist pastor was named Minority Business Woman of the Year for Northwestern Pennsylvania in 1990 as the entrepreneur behind her chain of beauty supply stores, Blanks Beauty & Barber Supplies and for her role as pastor at the church she and her husband, Joe, built.

She closed those stores in 2004, the same year she had her surgery.

Mary says her health problems began several years ago when her bladder totally fell through her vagina, something called pelvic organ prolapse (POP), a common occurrence following a hysterectomy. Her doctor sent her to a urogynecologist who said Blanks would have to have a sling implanted to hold up her bladder as well as a total rebuild of her vagina which was compromised during the hysterectomy.

Mary is no stranger to research. Online she found women saying they were in pain from the corrective surgery.

‘Don’t worry,’ said her doctor, ‘what’s on the Internet is always the worst.’

“That made sense to me,” says Blanks. Assured by her doctor, in October 2004 she had surgery in a local hospital in Erie to rebuild her vagina and to have a sling implanted to hold up her descending bladder and urethra. The doctor used layers of porcine (pig) graft mesh interspersed with layers of her own skin held in place with zero vicryl, a type of synthetic suture in a transvaginal surgery, through the vagina.

Blanks later found from her medical records that she had been implanted with the Monarc Subfascial Hammock, made by medical device maker, American Medical Systems, which had been placed in her through vaginal incisions using a Monarc stainless steel needle to thread the Prolene mesh graft under the urethra. Prolene is the commercial name for a type of petroleum-based plastic called polypropylene.

Blanks now says it was odd that she was treated for incontinence since she had not complained of that condition to her doctor, even though it appeared in her medical records that she had.

After spending less than one week in the hospital Mary was sent home. The first thing she noticed was she couldn’t walk. “About seven or eight weeks later I was still so sick and in so much pain,” she tells MDND.

“I wasn’t urinating, I felt like I wasn’t emptying. I felt like I was still full and I was so tired all the time,” says Mary today. And the pain continued.

When she returned to her urogynecologist and complained she was tired and in so much pain she couldn’t walk, she was given Elmiron to relieve bladder pain to be taken three times a day for the rest of her life. Her general practitioner gave her B6 and B12 shots for the fatigue.

Then there was a strange turn of event.

In October 2006 after her third time visiting the urogynecologist whom she describes as “the most loving, sweetest, good-looking doctor you’d ever want to meet,” the doctor committed suicide, leaving behind a practice of Ob-Gyn specialists and a family.

Mary’s records disappeared. It wouldn’t be until March of 2012 that she finally located her medical records which had been placed in storage.

Blanks returned to her family doctor still in pain – pain in her legs, her back, her stomach and throwing up. “It felt like somebody had kicked me between my legs,” she says. But Blanks says he also learned to adjust, and even began another business, J & M Beauty Services, as she went back and forth to the doctors.

As her family doctor was retiring, she now went to his daughter. The young woman commented on how good Mary looked.

“Every time,” Blanks says. “I’m in a business suit, that’s how I go to doctors.”

But Mary sensed a suspicion. “She kind of treated me like I was seeking drugs and I knew it but what could I do? I’m in her hands now. I said, ‘Look, please help me.’ Toward the end I was just peeing on myself. She told me it was part of growing old. I told her I couldn’t have sex. She said that comes with old age. I was 55-years-old! I wasn’t asking her for drugs, I was asking her to help me.”

Succession of Doctors

As often happens to women implanted with synthetic mesh for incontinence or prolapse and looking for answers - Mary Blanks began asking questions to a succession of doctors.

Her general practitioner (GP) told her to wear a pad and take the antibiotic, Bactrum every day. A trip to the Cleveland Clinic and she received a PAP smear and even though she complained about pelvic pain, Blanks said she never had a pelvic exam. Instead she was sent to a gastrointestinal doctor who swore she had suffered acid reflux disease for 20 years and put her on Nexium. She had a colonoscopy. She was prescribed Cymbalta to treat anxiety. Blanks went to the emergency room for pain and Blanks said every time she pointed to her right side and her pelvis and lower back and legs but never received a pelvic exam.

“I think this metal thing is coming loose inside of me,” Blanks told doctors believing she had been implanted with a metal medical device.

“It was all tied together. They were pretty much saying you must be crazy in so many words. Every time they checked me above and gave me pain meds and sent me home and said nothing was wrong with me. Pretty soon I believed I was crazy. They were blaming everything on fibromyalgia but that is different, it’s a whole other pain. I’ve learned to deal with that,” she says.

Blanks says she asked her GP who prescribed Cymbalta, “I’m in unbearable pain and I can handle pain, trust me. I’m one of those people who is okay with pain. You deal with it. I have a high tolerance for pain. I came out of her office I was in so much pain, begging her for something. My daughter went in and begged her to help me. Nothing. She said I’d be alright if I just took the Cymbalta and gave it a few days.”

Searching for Answers

Mary started connecting the dots. She asked for her medical records to see what the original doctor had done to her. Blanks is not the picture of health. She had suffered a heart attack. She had a metal knee implanted two years ago. She’s treated for fibromyalgia. But nowhere in the records did it clearly say she had been implanted with transvaginal synthetic surgical mesh.

By October 2011, Mary endured another trip to the ER then the hospital. This time she was throwing up and couldn’t stop. Her husband said she couldn’t keep it up. There she received a plethora of diagnosis – Blanks was told she had a growth on her ovary and it looked like cancer. Then her problem was diagnosed as a blood clot on her ovary. Then they said the growth was on her liver, but she needn’t worry. Blanks says she kept asking for a pelvic check since that’s where her pain was emanating from but doctors kept looking above the waist.

Blanks was assigned a hospitalist, a doctor who works inside the hospital. She warns, “You are not going to believe this.”

“I had been talking to the nurses. I’m a nice person and I like to talk to people. I has just got done saying I just didn’t understand why I can’t get someone to help me. Now you got to listen to me you are not going to believe me. I have a witness.

“I’m bent over in pain, I don’t know what they had me on and I’m still in pain. He said, ‘Look before we get started let me get you straight right now.’ I said excuse me? He said, ‘Let me get you straight right now. You said nobody would help you. I’ve given you pain medicine,’“ Blanks says she was told by the hospitalist.

“I said, ‘Sir, I’m not looking for pain medicine, I’m looking for some type of diagnosis to find out what’s wrong with me.’ I now know he was trying to bully me. I was confused. You know I’ve been nice to everybody.

“ ‘I don’t care how much pain you’re in,’ she says he said. By now I’m crying. ‘I don’t know what you’re crying about. I lift weights. You don’t mess with me, I’m a bad motherf*......’

“I looked at my husband and he was waiting for me to verbally tear him to shreds but I was too sick. I couldn’t believe it.

“My 6-foot 4-inch linebacker son is sitting in the corner and I’ve got my hand up trying to keep him away, afraid my son is about to throw this man through the window.”

After the abusive doctor left, the nurses came in to find out what happened.

“Then this man comes back in my room, Blanks says. He said, ‘Look don’t you worry about a thing. We’re going to send you home and keep you comfortable. You’re not going to feel a thing.’ ”

“I took that to mean he was sending me home to die. I’ve been at the death bed of too many people. I know exactly what that meant - drug me up so I can die! At some point there is no more you can do. That’s what he was telling me, there is no more we can do. I said ‘why are you saying this,’ and he walked out of my room.”

He sent her home with the antibiotic Bactrum and Endocet, an opioid pain reliever made up of acetaminophen and oxycodone. Blanks says she stopped taking the drug after it completely knocked her out.

A followup with her family doctor and Blanks was sent home with a prescription for 120 mg of hydrocodone with ten refills. “They don’t give out drugs like that, trust me.”

A Miracle Doctor

Before she went home, Mary Blanks experienced a visit from someone that does not appear on her medical records. Blanks says her witness is her husband who was also in the room. A man walked in her room and said he had something to tell her.

Blanks continues, “He said, Mary, I’m so sorry, what happened to you. I wouldn’t want it to happen to my mother, daughter, or my worst enemy. He said ‘you have transvaginal mesh inside of you and you’ve had it a long time going into your system.’ She continues, ‘It’s not that they don’t want to help you, we don’t know how to help you.’ He said, ‘My office didn’t use that stuff but a lot of docs use it like it’s the best thing since bubble gum. Mary, you’re basically screwed. Even if you find it, they’re not going to take you as a patient. He said if they take you as a patient, even after many surgeries, you’re still not going to be out of pain.”

Mary Blanks and her husband didn’t know what to say. She had finally found someone willing to look at test results and tell her the truth. She never found out the man’s name.

“He put me into action. He told me I had mesh inside of me and nobody can help me. I’ve got to find somebody to help me.”

Something else she found out later. Blanks says the hospital never mentioned her high white blood count which showed she was going to die. She either had lupus, cancer, or a severe infection going through my body. They cancelled out lupus and cancer.

“He knew I was dying. I appreciate and thank God for that. If he hadn’t told me that I never would have known what to do. He saved my life.”

Mad Woman with a Plan

She scanned the Internet. Blanks returned to her family doctor and asked why she hadn’t heard of the two warnings from the Food and Drug Administration, one in October of 2008 and another in July 2011 warning of the risks of synthetic transvaginal mesh including extrusion through the vaginal wall or organs, chronic pain, infections, scarring, shrinkage, neuromuscular problems, a return of incontinence and prolapse and multiple surgeries, among other complications, which the FDA said in 2011 were “not rare.”

Her family doctor hadn’t heard about it.

“I said I don’t believe you. How can the FDA miss you?” Blanks barked.

Another search found a doctor at a major Midwestern medical clinic who said he could help. He told her he knew how to remove mesh; he invented the procedure and he even teaches how to remove it.

“You know, I think I got my man,” said Blanks.

She was told by the doctor he could alleviate her pain by snipping a section out because the hammock was too tight. The doctor said he couldn’t get rid of all of the pain but he’d get rid of some of it.

Relief?

On March 14, 2012, Mary Blanks underwent surgery again. On the 17th of March, she says she almost died.

“Now I know what he did when he cut me, he loosened those particles again, so it went through my body like it was introduced again. My body had learned how to fight partially, now I’m fighting like hell all over again. So I’m throwing, up my chest is hurting, my stomach. I can’t explain, nothing would move. My husband had to carry me into the hotel room.”

Blanks says any time she moved she would get deathly sick again. Now she was unable to make the calls on her beauty supply business. She says she kept getting weaker, couldn’t walk and couldn’t breathe. When she went back to the hospital her oxygen reading was 61 and in the red. The nurse asked her if she wanted oxygen.

Following a pelvic exam, the doctor told her she had vaginitis. Maybe she should bathe more often.

“Now I’m seething. I’m praying, Lord, please help me.”

“He said, ‘Mary, are you talking to anyone?’ I said what do you mean? ‘Do you have a psychiatrist or anyone to talk to?

“So now you’re saying I’m crazy? You better get it straight. I’m a trained, licensed Methodist pastor. I talk to the Rock of my Salvation to have me standing here in spite of you, and he is the only one who has ever told me the truth. Doctor, the truth does not change. It’s the same yesterday, today and tomorrow. You told me you could help me and I’m standing here in worse condition. I’m on a cane and the best you have is I need to see a psychiatrist and take a bath? Are you kidding me right now? How dare you!”

Mary was sent home with a prescription for the antibiotic Cipro and one for Flagyl after tests showed she had a colony of bacteria growing inside her. Today she is bedridden. After finding women discussing mesh online, she’s made an appointment to consult with Dr. Shlomo Raz at UCLA on April 24 to have the synthetic mesh removed.

She told the Midwestern doctor all he had to do was keep her alive until then.

Mary has found a like-minded local doctor who will help her recover when she eventually returns from her removal surgery in Los Angeles. Getting him to promise not to use any mesh products wasn’t a problem. He told Blanks that pharmaceutical reps had tried to push mesh on his office, promising a five percent chance of erosion. Doctors in his practice went to receive training on how to insert the mesh. Even though they were all excellent surgeons, he said they couldn’t get the product to act as they were told during training.

After nine tries, six of the women returned with complications. They no longer use mesh. #

Learn More:

AMS YouTube video on placing the Monarc subfascial hammock- Warning- this may be disturbing to watch!

http://www.youtube.com/watch?v=_LtPE9-vUz8

Miklos & Moore explain Subfascial Hammock

http://www.miklosandmoore.com/pdf/TOT.pdf

FDA October 2008- Medical Device Alert and Notice, October 20, 2008 – This was the first FDA Public Health Notification about complications associated with surgical mesh used to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI).

http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/PublicHealthNotifications/ucm061976.htm

FDA July 2011- Alerts and Notice, July 13, 2011 – This was the second notice – FDA Safety Communication: UPDATE on Serious Complications Associated with Transvaginal Placement of Surgical mesh for Pelvic Organ Prolapse. This is a much more strongly worded caution about surgical mesh questioning whether benefit is worth the risk, but falls short of a recall. See symptoms the FDA has received from its adverse event database here.

http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm262435.htm

Mary Blanks- AMS Monarc Subfascial Hammock sling made of polypropylene. Blanks has not yet successfully reported to the FDA's MAUDE database though she says she has made several tries over the phone, but gets cut off before the call is completed. She says she will continue to try.