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.”
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.
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.
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.
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.
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?
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.”
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.”
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.
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.