I understand and often feel the same way. The public doesn’t think journalists have standards but there are very strict standards for the best journos and I believe he is very good.  But I insisted, I’ve flown myself to the FDA hearings, I’ve been following the issue since 2009 and am truly interested in the topic and feel it’s an important story of our time. I’m not soliciting for the attorneys, they just offer some support! Do I have to take a vow of poverty to be a journalist? The New York Times takes ads for BMW, does that mean there is a conflict? I was getting a bit flustered and I’m afraid it showed.

It fell on deaf ears – any association with lawyers is a conflict. Some other journalist will have to do the story.  Maybe they could interview you, he said.  Right.

Sometimes you can’t catch a break.  Anyway here is the story I did. Too bad they won’t read it in In These Times.

###

The email came in on February 21, 2012. It said “Please Help Me”

Okay I thought, this is a scam. Someone crying that their funds are tied up in a Ugandan trust and they need me to forward cash. Right.

But lately I’ve heard from too many people who are desperate for answers because they are in severe pain following a common medical procedure – the implantation of synthetic surgical mesh to treat hernias in men and women and pelvic organ prolapse and incontinence in women. So I clicked.

“Jane, I am sitting in a hotel room here in Washington DC.  Flew in from far west Texas to see a doctor to consult about mesh removal for my mom. This doctor was highly recommended.   My mom is in such pain and has been for two years…the flight alone was hell.  She was a very active woman prior to having this put in her.

This was a waste of time and money as the doctor here acted like this was no big deal and referred us to some urogynecologist in Albuquerque.

Jane, I don’t know what to do.  I have never seen my mom cry like this.  I have never seen her so weak and scared.  No one in my web research will say with clarity who to trust.  I am flying back home tomorrow with my mom and I am more confused than ever. My mom is saying things like “I just give up.”

What do I do?  PLEASE PLEASE give me any guidance you can.”

The woman left her phone number and email.  Her mother turned up in a cursory Google search to be who she claimed. I called the daughter.

There are thousands of men and women living in debilitating pain from permanently implanted synthetic petroleum-based surgical mesh. Turning to me as an option shows just how desperate these people are. I’m not a doctor or a lawyer but a journalist who began writing about mesh complications in the spring of 2009 after being contacted by a persistent mesh victim.

I couldn’t believe what I heard.  For some reason, in some people, mesh migrates and perforates organs, erodes into the vagina, can cause a systemic inflammatory response and intense pain all over the body. In men, hernia mesh has been known to entangle nerves and form a hard plastic ball. The actual complication rate is unknown even by the U.S. Food and Drug Administration (FDA).

The thousands of mesh-injured men and women are victims of a perfect storm – the aggressive marketing of the medical device industry paired with the hands-off regulation by the FDA toward medical devices which relies on the mesh makers for assurances of safety and efficacy.

And while I tell the stories of women and men who are injured by surgical mesh on my Mesh Medical Device News Desk (MDND) website, there is very little I can do to help. I don’t refer the injured to lawyers or doctors, despite receiving support from two law firms, but what I do, as I did here, is put her in touch with women and men who have gone through the same living hell and are now advocating for others.

Many who I talk to are bankrupt and without insurance. Others return to their original doctor only to be turned away with phrases like, “You’re the only one I’ve seen,” and to be given a prescription for an antidepressant.

Others begin a succession of specialist visits only to be met by a wall of resistance and denial.  In some cases, a doctor will attempt a removal only to leave the arm of the mesh behind which often leaves the woman in worse condition.

 “On return to the doctor who placed the mesh in me, he claimed upon re-examination that he could not find anything wrong. I suffer with excruciating pelvic pain on my left side radiating into my lower back spine left side. I’ve had CT scans, a MRI and can’t seem to diagnose anything. I can’t stand or sit for long periods or walk. NO one can help me. I’ve been to three different OB-GyNs with the same thing, we can’t find anything.”

A man told me his mother was in such pain from a mesh implant that she shot herself to end the pain.

HOW DID WE GET HERE

An estimated 13 million American women experience stress urinary incontinence (SUI), a leak of urine that can happen during a sneeze, laughter or physical stress. It’s estimated about 20-40% of women have some form of incontinence.

Pelvic organ prolapse (POP), involves the decent of pelvic organs, the bladder, urethra, small bowel, rectum, or uterus, through the vaginal vault due to weakness of the connective tissues due to multiple births, age, hysterectomy, menopause and injury. Some experts feel we inherit the collagen which makes connective tissues and muscles strong. Exercise, or the lack of, may play a role.

Except in rare cases, POP is a nuisance but not life-threatening and many women are asymptomatic. The condition can be maintained by using a pessary, a rubber insert that holds back descending organs, making lifestyle changes, and through surgical intervention to stitch up the anterior or posterior vaginal wall.

Surgical mesh was first used to repair abdominal hernias in the 1950s, but fast forward to the 1990s and fuelled with aggressive marketing pushing a host of new petroleum-based materials, gynecologists began using synthetic polypropylene or polyester surgical mesh, some delivered in precut boxes, to hold up the urethra or the vaginal vault.

The FDA reports about 300,000 U.S. women underwent POP repair in 2010 with 75,000 of those procedures involving transvaginal (through the vagina) implantation of surgical mesh. And even gynecologists, many who were never trained as surgeons, can attend weekend cadaver training sessions offered by the major mesh makers – Ethicon (Johnson & Johnson), Boston Scientific, American Medical Systems, and C.R. Bard to learn how to implant mesh in the blind procedure.

One woman told MDND her doctor said this new surgical option for his practice would be his “bread and butter.”

510(k)

“Biggest regret of my life, as it has ruined my life, my sons childhood, and my hysbands and mines marriage. Its truly a living hell. ~ 25-year-old implanted with mesh after a hysterectomy.

Most Americans assume that medical devices undergo the same sort of scrutiny as pharmaceuticals, but they would be wrong. Ninety percent of the 4,000 medical devices approved for market by the FDA every year do not require proof that they have been clinically tested for safety and efficacy.

Instead, they are approved under the 510(k) process –a fast-track system that’s an approval for marketing. Device makers like the relative low cost and ease that can bring their device into the marketplace after an exchange of paperwork.

Most of today’s gynecologic mesh can thank Boston Scientific. In 1996, the FDA cleared its ProteGen Sling for market which served as the ‘predicate,’ a device “substantially equivalent” to the new one seeking approval, required under the 510(k) process.

From 1992 to 2010, the FDA cleared 168 510(k) for synthetic surgical mesh for urogynecologic conditions, many which named the ProteGen as  predicate. But there was a problem.

ProteGen was recalled in March 1999 for being defective, “adulterated and misbranded.” But there is no trigger within the FDA to initiate a re-review of all of the devices that had named the defective ProteGen as a predicate.

The FDA reports in 2001 the number of clearances per year doubled and increased another 50 percent the following year.

And so did the complications.

By 2011, the agency reported 2,874 reports of injury, death and malfunctions from January 2008 to December 2010 associated with urogynecologic surgical mesh – a fivefold jump. Falling just short of a recall, a Public Health Notification by the FDA in July 2011 warned of the risks of mesh.

“The FDA is issuing this update to inform you that serious complications associated with surgical mesh for transvaginal repair of POP are not rare. This is a change from what the FDA previously reported on Oct. 20, 2008. Furthermore, it is not clear that transvaginal POP repair with mesh is more effective than traditional non-mesh repair in all patients with POP and it may expose patients to greater risk.”

DOCTORS ON BOARD

Daniel S. Elliott, MD, Assist Professor of Urology at the Mayo College of Medicine in Rochester, MN specializes in female urology and pelvic organ prolapse. He told MDND that the Mayo Clinic refuses to use mesh for transvaginal POP repair because it carries more risks than added benefits.

“On a weekly basis, either I or my colleagues evaluate and treat patients suffering from the consequences of the non-absorbable mesh kits. The diagnoses run the gamut of mild vaginal erosion (or extrusion) to devastating urethral and/or bladder erosions with severe, debilitating, life-altering chronic pelvic pain. The patients have suffered needlessly because the standard POP repair without mesh, in properly trained hands, is easy, fast, and effective, avoiding the unique complications associated with non-absorbable mesh kits.”

Dr Elliott has joined Public Citizen in calling for a complete ban on synthetic mesh until multiple independent, non-industry supported research can show any benefit.

“Anything less would be surgically irresponsible and ethically unacceptable.”

SUFFERING IN SILENCE

One woman, who does not want to be identified, had a professional life including a waterfront home in Florida, a successful business, and a nice car.  When she went in for a hysterectomy, she mentioned to her doctor she sometimes suffered from incontinence.

Her doctor told her not to worry. He said he had a new tape and she’d really like it. She was implanted with the  Ethicon TVT Prolene polypropylene mesh.

Thirty-six hours after being released from the hospital she was back with a raging flesh-eating infection which almost took her life. Shes undergone nearly 20 surgeries since for infection and mesh removal.  She points out that the mesh package insert says Prolene mesh may have to be removed because it can “potentiate an infection.”

Dr. Donald Ostergard has published reports that say mesh is not inert in the body. Produced with antimicrobials, adhesion preventatives and surfactants, it may be impossible to measure the chemical reactions between the polymer mesh and the human body which can lead to a host of problems including chronic inflammation and autoimmune diseases.

BREAKING THE SILENCE

A petition filed by Public Citizen last August joins in the chorus demanding synthetic mesh be recalled from the market and reclassified as a Class III medical device which requires premarket approval application (PMA) that includes data from clinical trials that provide a reasonable assurance the product is safe and effective.

Consumers Union in February of this year launched its Safe Patient Project  to urge more rigorous testing on all permanent medical implants before they are marketed and to establish some tracking system not unlike the VIN number on a car. At the present time there is no registry for medical devices.

Most people I interview for MDND don’t even know what kind of device they have until they start requesting pre-surgical notes.

At the present time, it’s easier to track a defective Toyota than a defective implanted medical device.

Like Public Citizen, Consumers Union wants to abandon the 510(k) process and to start some sort of post-surgical registry.

Rep. Edward Markey in his Sound Devices Act, wants to eliminate the use of a predicate device like the ProteGen sling when it has been found defective. Rep. Henry Waxman is requesting the House Energy and Commerce Committee hold hearings, but the requests are falling on deaf bipartisan ears concerned that the medical device industry may suffer in sales and innovation if the protests get too loud.

In an effort to catch up, last January, the FDA ordered 33 mesh manufacturers to begin collecting as much as three years of safety data on the implants.

FEW REMOVAL DOCS

“Mr. Hansen, I am tired.  I get up every day dealing with my own painful symptoms and then I read the stories of others.  It is too much for me and a tiny group of women to handle alone.  We need your help. 

I will hopefully have mesh removal later this year by the best and most experience surgeon in the world.  I will turn sixty-five in June and at last have Medicare insurance to see this doctor.  His name is Dr. Shlomo Raz of UCLA.  He knows the truth.  He is so booked up with mesh removal surgeries, that is difficult to get an appointment.

“Please Mr. Hansen. Help us.”

~Mesh Patient Writing to Chris Hansen of Dateline

So far the consensus is Dr. Shlomo Raz at UCLA is the premier doctor in the world for mesh removals and approximately 100 – 150 women a month fly in from around the globe to have him peel eroding mesh off of their bladder and spinal column. His assistant, Elizabeth, says Dr. Raz finds a great deal of comfort from the thank you letters he receives from the grateful women.

Meanwhile hundreds of lawsuits against manufacturers have been filed and have been consolidated in the Southern District of West Virginia in multidistrict litigation to be heard sometime in 2012.

Synthetic mesh remains on the market.  #

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Twin sisters Linda Dodson and Brenda Mann Jones

Linda Dodson, a dark-haired, attractive Georgia peach with a long southern drawl to match decided to visit a new gynecologist near her home in Georgia, just south east of Atlanta. After about 30 minutes on the exercise bicycle she would experience a muscle spasm in the urethra area. Not a big deal, she thought. The slight pain, along with her desire to be on hormone replacement therapy after a hysterectomy, had her in the doctor’s office in Stockbridge, Georgia. She explained the urethra area pain and since he was a new doctor and she wanted to be thorough, she added she had occasional urinary tract infections and that sometimes her bowel did not empty completely.

“I can fix that and the surgery is a walk in the park and when I finish with you, you’ll look like a sixteen year old,” her new gynecologist said according to Dodson’s notes she would later forward to the hospital.

Dodson scheduled her surgery for January 26, 2006. The 53-year-old Dodson had two grown children, a loving husband, Alto, and was a healthy woman who worked out about 12 hours a week combining cardio with weights. Professionally she was a self-made woman who had worked her way up through the ranks of Georgia government. Beginning in 1970 with a GED, she started as a utility worker with the Georgia State Patrol and continued climbing the career ladder for the next 28 years through various state agencies in managerial positions and eventually retired in 1999 as the Personnel Manager for the Georgia Department of Defense.  She was also responsible for making sure that the Georgia National Guard troops were paid when the Governor activated the guard.

She understood the regulatory role of government and how to apply rules and ethics to any particular situation.

Yet when it came time to prepare for surgery, life got in the way. Her husband had been in a car accident and her mother-in-law was moving into a nursing home. Dodson and her husband were planning to locate soon to Tennessee to be near their children and grandchildren. She signed the obligatory paperwork “I didn’t know what he was planning to fix. I’m embarrassed to say I did not ask questions. Our generation is very trusting of doctors.”

Linda and grandkids Peyton, Cole and Madison

Dodson told her identical twin sister, Brenda about the doctor and that he seemed nice. Brenda scheduled an appointment.  The doctor told her she had a small bulge in her vagina, though Brenda says she didn’t feel it. Brenda’s prolapse surgery was scheduled for February.

“The Informed Consent form I signed stated, ‘tighten the vaginal muscles around bladder and rectum.’ I did not sign a consent form giving him permission to use a synthetic mesh material on me.  This was an elective surgery. I did not have any urinary and/or rectal incontinence problems,” she tells MDND. 

Surgery

Dodson’s surgery was scheduled for January 26, 2006 at Henry Medical Hospital in Stockbridge, Georgia, an outpatient surgery center. When she came around at first there was no pain, but within a half-hour, when the narcotics wore off, Dodson says the pain was excruciating and she was hemorrhaging. The doctor ordered 4 milligrams of Dilaudid.

About 45 minutes after it was administered, the nurse asked Alto, if Linda’s breathing appeared normal. Her deep belly breaths resembled sleep apnea and she appeared pale with her pulse oxygenation down to 32 percent. The nurse thought the machine was broken so a second pulse oxygenation monitor was brought in and her husband saw another 33 percent reading. He knew what a low oxygen level meant and immediately started pulling on her right arm and screaming Linda’s name. Linda’s head just rolled around. She was unconscious and personnel rushed in as a code was called and other nurses performed CPR to resuscitate her.

Alto was sure Linda was dying and fell to his knees in the hallway praying.  Several nurses asked him if they could give him something to calm him down.  The first nurse came out and told Alto they were still working on her.  As time went on, a nurse finally came out and told him that his wife was going to be OK.  He asked to see his wife and the nurse responded by saying, “let us clean the room up.”  An anesthesiologist came out and explained to her husband that his wife was allergic to Dilaudid.

Dodson’s research has found, “You’re supposed to start someone who is not used to taking Dilaudid on 0.5 milligrams. He gave me 4 milligrams.”

Her hospital records she later gathered said nothing about the overdose or the true degree of effort that the hospital staff used to save her life.

Dodson was in an outpatient clinic. No cardiologist was ever called. She never was sent to intensive care. The many doctors she’s visited since have all told Dodson she was just breaths away from dying.

She found out the truth a week later when she had another procedure scheduled to correct the rectocele hematoma that resulted from her surgery.

The anesthesiologist informed Linda in pre-op that she coded last week from an overdose and almost died. Linda started crying. She would later learn the hematoma caused permanent damage in her rectal area and that a foreign object, a gel foam sponge was left in her body. Her body was black and blue from the top of her chest to her belly button from the resuscitation.  Linda experienced back and neck problems after the first surgery.  After a year, a specialist diagnosed her with a 10% fracture of her T-8 vertebra, which the doctor said was caused by the resuscitation.

To this day, Dodson questions WHY she would allow a doctor to perform an unnecessary, elective surgery on her when she was non-symptomatic of prolapse or incontinence?  The only explanation she can find is that she was under a great deal of stress and was not thinking clearly.

After reading hundreds of health message boards where other women posted about their own surgical mesh complications, Dodson discovered she was not the only woman who did not question her doctor.  “We were raised to trust our doctors,” she says.

What’s Mesh?

Two days after Brenda had her surgery, along with some bleeding complications, she returned to the doctor.

“What’s mesh?” she asked Linda. The doctor had told her Brenda and Linda were number three and number four patients on whom he had used the Ethicon (Johnson & Johnson) Gynecare Gynemesh PS. He had received his training in a hotel conference room.

Brenda and Linda’s sister, Dianne had accompanied them to the doctor’s office. Dianne says of the doctor, “He told me this was his bread and butter.”

Linda immediately did a self-examination and felt screen material in her vagina. Back for one of her last visits, Linda told the doctor she had mesh eroding into her vagina. The doctor said he couldn’t find it.

“I sat up on the table and said ‘Put your finger in my vagina and it’s up on my left side.’ By this time, I wanted to kick him. I knew he was a quack.”

The mesh erosion caused vaginal burning and pain every time she walked. She wanted it out.

“He told me I’ve got a little surgical room in my office, I’m going to call the sales representative and we’ll do a mesh excision.”

That’s the last time Linda saw the gynecologist.

Get the Mesh Out

In February 2006 after Dodson retrieved her medical records, she called Ethicon.  A nurse named Rita explained if she could feel the mesh in her vagina it would have to be removed. Ethicon provided a list of physicians in the Atlanta area familiar with the mesh product. She chose a surgeon in Marietta, Georgia who performed two separate surgeries to remove the mesh material in her cystocele area in March 2006 and another in July 2006.

Each procedure involved an overnight stay in the hospital.  With no notes in the original surgical procedure on what size mesh or how it was placed, the second surgeon told her he couldn’t be absolutely sure he removed it all.

Calling Ethicon

By July, 2006, Dodson was experiencing post traumatic stress from her medical ordeals and near-death experience, but in good faith she contacted mesh-maker Ethicon, based on the assumption a manufacturer would want information on their product’s complications.  Dodson says she had no desire to pursue a product liability lawsuit but wanted them to know about her doctor so other women wouldn’t be harmed.

“I was hoping by providing them with this information that it would be helpful for them in determining if this mesh product was safe for their continued intended use. Unfortunately, I didn’t understand at the time how manufacturers operated, and how they processed information once they receive it,” she later wrote in a formal complaint to the FDA.

It was now Linda’s over two decades of work in government, understanding a mission statement, code of ethics, regulation, and knowing how to research, gather and present information, kicked into high gear.

Wrigley gum twin contestants, Linda and Brenda

Calling on the FDA       

In February 2007, Dodson and her sister, Brenda Mann Jones met with the officials in the Atlanta FDA office to present a 27-page complaint letter. Dodson questioned how physicians can have adequate training to perform mesh surgery from the Ethicon website and in weekend training sessions; why the Adverse Event Reports have a “clear pattern of claiming “User Error”; why patients are blamed for their injury outcome; why Ethicon recognized reactions including infection, inflammation, fistula formation, erosion, extrusion and scarring, while its promotional literature made uplifting promises of long-term positive results?

Dodson found entries from medical reviewers for Ethicon who questioned a woman’s desire to be sexually active again as a reason for mesh removal. She scoured medical journals through Medscape looking for complications and found studies from Greece to New York that posed unanswered questions by researchers about the high percentages of post-operative complications, including mesh shrinkage, infection, erosion and dyspareunia (painful intercourse).

She asked the FDA to investigate whether or not Ethicon was underreporting its adverse events and asked the agency to take immediate regulatory action in investigating all of the nine mesh manufacturers.

And Dodson suggested since adverse event reporting is not mandatory by physicians, and two of her physicians had not reported complications to the FDA, might there be thousands of other women with complications that go unreported?

Researching Mesh

When the FDA issued its first Public Health Notification in October 2008, concerning serious complications with synthetic mesh materials, Dodson was not happy.

She spent thousands of hours researching mesh, the FDA protocol, and complication rate data, known as “adverse events” on the MAUDE database within the FDA website.  Dodson sent a 58-page letter to the FDA. Administrator, Ann Ferriter, the Director of the Division of Risk Management, an analyst for the Office of Compliance within the Center for Devices and Radiological Health which oversees medical devices. She questioned why deaths and permanent disabilities were being “systemically diminished “by the FDA and urged a “Public Service Announcement on national TV to alert innocent consumers.”

Ferriter sent a letter back, complimenting Dodson on her letter and research.

“All I did was go through the nine companies that manufacture surgical mesh and broke down the adverse events by patient hospital reports, repeated surgeries, hospitalizations and deaths,” Dodson says.

“Once the FDA saw that broken down, it got their attention. If they were monitoring their own database they could have captured the same information that took me seven days to compile.”

Jason and Becca Dodson with Peyton, Madison and Cole

Testifying to FDA Panel of Experts

In early September, 2011, Dodson reminded an expert panel, gathered to decide the fate of mesh, that the FDA had warned the general public of a potential health hazard when tainted dog food killed three dogs.

“What prevents the FDA from holding a public interest press conference and make people aware that these medical devices can cause life threatening adverse events? Is an animal’s life more precious than a human’s life?” she asked the panelists.

Though she had practiced her presentation to fall within the five minutes allotted time to the public to speak, her microphone was cut off before she finished.

In her last sentence, Linda was able to say, “In my opinion, if Commissioner Hamburg fails to warn the public about this medical device then I will consider it a serious dereliction of her duty.”

Postscript

Linda says in recent years she’s seen an endless succession of specialists including digestive doctor’s, a colorectal surgeon, a urologist, an infectious disease specialist, an Eye, Ear and Nose and Throat Specialists, a Neurologist and a Urogynecologist. She’s had CT scans and two MRI’s and been to the emergency room a few times. On one ER visit, she was diagnosed with a fistula.  Instead of receiving treatment for the fistula, she had her appendix removed after inflammation was found (the pathology report on the appendix came back normal).

Her out-of-pocket medical expenses for these diagnostic tests and medicals were not covered by her health insurance or she paid the co-payments.

“Prior to having this unnecessary mesh surgery, I was very healthy and active.  However, since this surgery, my body feels like I have the flu all the time, I still hurt in my buttocks when I walk, and still have pain in my urethra.   There’s not a day that goes by that I do not experience pain in my surgical areas.  I have been to many doctor’s with a long list of symptoms, and a lot of tests have been run on me but not one doctor has been able to diagnose and/or explain why I feel the way I do.  The only medication that helps me feel non-symptomatic with the flu-like symptoms is when I take an antibiotic.”

Because of a state cap on medical malpractice damages, no Georgia lawyer was interested in pursuing a case against the doctor.

Linda has become a strong patient advocate, not just for herself, but also for a lot of other women.  She says she’s empowered herself with knowledge and she will never allow another doctor, hospital or anyone else in the medical field to treat her with such total disregard as the doctor did in Stockbridge, Georgia, along with Henry Medical Hospital.

“No one should have had to experience what I experienced.  Yes, post-operative complications do happen but when they do, doctors and hospitals should own up when they make mistakes.  Patients can handle an explanation when errors occur, but WE cannot handle errors with blatant lies and cover-up.  I was lied to on numerous occasions.  These lies only added to my mistrust of medical personnel.”

Linda does believe that there are a lot of skilled surgeons that are working in the patient’s best interest but there are also doctor’s who are performing unnecessary surgeries on women for their own greed.

The Dodson family

And she learned the first line of treatment for a cystocele and rectocele prolapse is education, and sometimes medication, along with exercise.

“Surgery is NOT recommended for a rectocele or cystocele if it’s a degree three or less.  However, some doctors are bypassing the non-surgical treatments and taking their patients directly to the operating room.  This is wrong!  Our doctors should be educating women on these health issues.”

Linda says her sister is in pain from the waist down and finds it hard to move. “She has to do something’ she says, and may have mesh removal surgery.

As for Linda Dodson she says she will not stop until the FDA recalls synthetic surgical mesh or the manufacturers issue their own recall.

“The FDA’s role is to protect people and families and not put us in harm’s way due to greedy manufacturers.  They already know their product is a problem. It doesn’t take the FDA to tell them to recall their product.  The presumption is there under FDA rules – if it’s a problem and can create a problem, it doesn’t need to be on the market.” #

Linda Dodson and her family currently reside in the Loudon, Tennessee.

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