Lisa Elford-Pashenee was mad as heck and didn’t want to take it anymore.
She was tired of unresolved questions about her vaginal mesh complications, about a succession of doctors who denied she had a problem, and about a California HMO that denied her a referral to a doctor who could help remove the mesh.
In 2004, Pashenee, then 41, had a Gynemesh TVT sling implanted for urinary incontinence. She tells MDND her incontinence was not bad, but she did leak urine when she had a cough or sneeze. Lisa says she mentioned it to her Ob-Gyn who said he had something that would do the trick.
“Back then they didn’t know there were complications,” she says, referring to the abundance of information that is available online today. “I was told it was permanent and not meant to be removed. I wasn’t told about the complications and risks.”
Pashenee says during the surgery the mesh was inserted vaginally through two holes put on either side of the vagina. She was brought out of anesthesia and told to cough. When urine leaked, the doctor pulled up on the mesh ends and told her to cough again. Again the mesh was tightened.
Chronic Bladder Infections
Pashenee says for two years it“worked great for two years,” as far as urine leakage. But there was another problem that would soon be become chronic. In 2005 she had had 4 bladder infections and every year she would experience a minimum of four to six infections. But Pashenee says they were minor and were treated with antibiotics.
By the time the round of antibiotic was gone, so was the infection.
By July 2011 she went in for urodynamic testing to determine why she still had leakage. The urogynecologist said she may need to double the mesh but the test came out okay. Then he sent her for acupuncture.
The succession of antibiotics and infections continued for years until October of last year, when Pashenee says she has a bladder infection for 36 days. When she felt a urinary tract infection beginning her abdomen would seize up and out of nowhere a sharp pain would cause her to cry out. “I felt it pulsating inside of me for two hours,” she says.
Lisa thought it was a really bad urinary tract infection.
Even with four different medications, the infection would not go away. In the last eight months, Pashenee says she had 11 urinary tract infections, one right after another. At the writing of this story she has another.
Her urogynecologist denied there was any problem when Lisa suggested it might be the mesh.
“Show me the data on infection,” she says she was told, though the doctor had seen data on mesh erosion. Both are listed as complications of mesh implants by the U.S. Food and Drug Administration (FDA) which has issued two Safety Notifications to the public about the dangers of surgical mesh. Instead, the doctor said everything was fine and he sent her for acupuncture.
Her Own Investigation
Lisa decided to begin her own investigation. Online she found sites where women talked about repeated bladder infections caused when the mesh was pulled too tight. She also found recommendations for four doctors, one who told her if she didn’t have bladder infections before the mesh and had them afterward, the mesh had to be implicated.
During January and February her doctor had her taking the antibiotic, Septra, used to treat urinary tract infections (UTI).
Going back to her original doctor, she was tested for mesh erosion in February. A kidney ultrasound showed no kidney stones. The doctor told her he knew of two other women with the older TVT mesh and recurrent multiresistant infections and he might have to begin to “experiment” to take it out.
That was all she needed to hear.
Lisa asked for a third time for a referral outside of the HMO to one of the four doctors others online had mentioned who had experience with plastic mesh removal. She was denied once again.
“They don’t care. I thought are you really going to let me die?” she asks today.
Instead she was referred to a urologist who confirmed her problem was caused by the presence of the plastic mesh. The body had lost its ability to fight infection she was told. Lisa says that same doctor never did an exam but did do removal surgery June 6, 2012. When she woke up from anesthesia, Lisa says she was told by the urologist that she was unable to find the mesh and therefore did not remove it.
Lisa says she started crying. She was told it might have absorbed by her body, but one of the four recommended doctors she found online emailed her that that was impossible. Gynemesh is not absorbed by the body. Make sure it’s Gynemesh. Lisa did. She was told it must still be there, but the urologist within her HMO said there was nothing more they could do.
Last March, Lisa was referred to an infectious disease doctor who did cultures on her which came back with evidence of a superbug, Extended-spectrum beta-lactamase (ESBL) and its cousin ECESBL, bacteria resistant to beta-lactams antibiotics such as penicillin.
“My infectious disease doctor said e-coli had colonized around mesh,” she tells MDND.
“I was told the reason I developed these was because of so much medication over the years, I became resistant to all oral antibiotics. I was told I would have to turn to injections of antibiotics.”
This presented two problems – first, she didn’t know how to do an injection and second, the antibiotics recommended had side effects. With no urgent care center to turn to to teach her how to administer the injections, she got help from an M.D. who came to her aid as a favor.
She was told the injections were important because they might be the last defense to save her life.
The first one was the antibiotic, Amikacin, often used for treating hospital acquired infections. Lisa read the product insert. It said she could lose her hearing from the drug. After five days Lisa said her ears began popping and felt like they plugged up. After 10 days she emailed the doctor who wrote the prescription to request a hearing test which showed she had mild hearing loss in the left ear. The doctor who had come to her aid with the injections said she should have had a baseline hearing test before the antibiotic which also can damage your eighth cranial nerve. Her urogynecologist sent her to have an ear wash.
Pashenee then began a second once-daily injectable antibiotic, Invanz.
In the first three months she says she received 34 shots to quell the bladder infections. Finally, her husband learned how to administer the shots. By this time Lisa says she was warned not to miss any injections of antibiotic since she had become resistant to other antibiotics and an unchecked infection could end up in her bloodstream with fatal consequences.
Feeling a sense of urgency now, Lisa tried to go outside of her HMO seeking a referral.
“I was told they would not pay for a consult when we have 13 credible urologists here.”
Stop Playing by the Rules
To make matters worse, Lisa says there is a shortage of Invanz and she can only receive small amounts at a time. So after four different doctors, surgery, a battery of test, ongoing infections and antibiotics and no answers Lisa says it was time to stop playing by the rules.
“If you can’t win by paying the rules, you’ve got to break the rules. I’m not going to lay down and die. I have a 12 year old and a 17 year old. I’m 49.”
Her son set up a Facebook Event page and invited people to a gathering to picket for his mom’s life.
Placards and picket signs were made most mentioning mesh. “Don’t let mommy die,” “Mesh equals death.” Lisa says she called the police to inform them ahead of time. Lisa expected maybe eight people to show up for their peaceful protest outside of the HMO headquarters.
Lisa says 25 people walked outside of the HMO headquarters on Thursday, June 21, complete with bullhorns. Lisa wore her red Rosie the Riveter shirt.
“Within 20 minutes security came out and I gave her a flyer,” Lisa says.
A half hour later, an unidentified woman and a female doctor came out and invited her in for a meeting.
“Okay I went up there and four people listened to me. They tried to send me back to my original doctor, they even pulled him out of the operating room. He is willing to help you, they said. But I answered, no he’s not, he’s willing to experiment on me. I said I don’t want him touching me.”
Lisa says she left and went back to the picket line.
But 30 minutes later the same two women came down and said that after talking to Pashenee’s doctors and the physician’s board, a decision was made to refer her outside of the HMO to UCLA. One of the women in the room, a doctor added that there is nothing wrong with mesh and it is the ‘gold standard’ and still the best treatment for urinary incontinence.
That was not what Lisa wanted to hear but the referral was.
Dr. Shlomo Raz is the premier surgeon in the world for mesh removal visited by women who fly in from around the globe to UCLA Division of Female Urology, Reconstructive Surgery and Urodynamics to have the polypropylene mesh removed when no one else can help.
Lisa called off the picket.
On July 1, Pashenee received an authorization for an appointment for a consult and translabial ultrasound at UCLA with Dr. Larissa Rodriguez, MD, who shares the same clinic with Dr. Raz in mid-July for an initial consult. Testing, using a specialized MRI, will follow in another appointment and then hopefully surgery to remove the “gold standard’ from her body forever. She has confidence UCLA will find the mesh no one else has been able to and she will be able to stop the antibiotic injections.
She has filed a complaint into the FDA’s MAUDE database.
Why did she turn to the picket line?
“I don’t know why everybody doesn’t do it because I did everything I was supposed to do. Even four to five doses of pain injections were not helping me and I finally let them do the surgery. It was unsuccessful. I appealed and they said no. I was in a union and I know companies don’t like publicity. So I thought everybody needs to know about it. The mesh is the big thing, it’s not about me, it’s about the mesh,” she says adding, “and they’re still putting it in!”
Lisa adds, “What if we organize a national picket on the White House with mesh survivors, friends & relatives & women in general? If the FDA won’t recall it, we should stand up and protest! Worked for me! It would if nothing else gets the word out to women everywhere not to do it. We could call it a mesh convention.” #
Two FDA Public Health Safety Notifications- Transvaginal Mesh Complications
October 20, 2008
July 13, 2011
FDA Executive Summery – July 2011 – Urogynecologic Surgical Mesh
How to Post an Adverse Event with the FDA