The FDA requires Medical Device distributors to track your device up until and including your death—including your name, address, phone number and social security number. Title 21 of the FDA regulations require the device distributor, final distributor, or multiple distributors (devices that move from patient to patient), promptly upon purchase, provide the manufacturer the name and addresses of all distributors along its journey to you, including the lot number, the date the device was received, and the person from whom it was received.
Tracking Devices vs. Device Tracking
The last distributor before your implant must also provide the manufacturer with their own name and address, the unique device identifier (e.g. lot or serial number), your name, address, phone number and social security number—unless you refuse to release that information under 821.55(a).* They must also record the date of your implant, name, address, and phone of both implanting surgeon and regular physician, and the date the device was explanted.
If a patient dies, the end point distributor must provide the date of death, name, address, and phone of treating physician, date of any explant with contact information for explanting physician, and, where applicable, and the date the device was returned to the manufacturer, retired from use or disposed of in any other way.
* Any patient receiving a device subject to tracking may refuse permission to release their name, address, phone and social security number or any other identifying information but, the hundreds of pelvic mesh implantees who were not told they had an implant or that a tracking system exists, would have no way to refuse permission. Title 21 can override a patient’s right to privacy if the “health or safety of the patient requires that such persons have access to the information.”
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Today’s press release from the Lawfirm Newswire stresses the importance of reporting injuries from TVM.
“Former FDA Program Manager, Madris Tomes, now the founder of Device Events, firmly believes all TVM kits are dangerous. Additionally, although many of the adverse event reports deal with ongoing symptoms, a question arises whether TVMs could cause deaths.
Due to the nature of the reporting system, death may be reported as malfunctions and injuries. Based on current information in the FDA reporting system it is allegedly not clear how many deaths may be related to TVM kits. However, according to Medscape, an FDA review of records for all urogynecologic mesh products spanning the years 2005 to 2010, there were 3,979 reports of malfunctions, injuries and deaths.
“It was not until 2011 that the FDA announced that the serious complications with the TVM kits everyone was reading about in the news were not rare — a reversal of its original stance on the product issued in 2008,” said Austin TVM attorney, Bobby Lee. After the FDA released its revised position on TVM kits, it was revealed they had been sent over 4,000 complaints involving TVM malfunctions, injuries and/or deaths over a five-year period.”
Rosey Y died in 2013 after a string of illnesses after she was implanted in 2006 with a the Gynecare Prolift transvaginal mesh to treat pelvic organ prolapse. The Prolift had been introduced by Johnson & Johnson (J&J) in 2005 without an approval from the Food and Drug Administration (F.D.A.) and wreaked havoc on unsuspecting women until it was taken off the market in 2012.
Rosey’s sling sawed itself out of place, slicing right into her vagina and causing her last few years to be filled with infections and chronic suffering. She became totally disabled. “I sure never thought that some day I’d be crying just cause I can’t stand to wear underwear, much less pick up my grandkids,” she said. “After the surgery I couldn’t walk properly and was in constant cutting pain. Doctors say I am the first patient to ever have these problems.”
Pelvic Mesh MAUDE Deaths
Very little is known about forty-nine people who died unexpectedly after pelvic mesh implant surgery. Small traces of their loves, their lives, and their lost futures appear “between the lines” in sparse, single paragraphs written by complete strangers and submitted to the F.D.A. in an Adverse Event report. There is no report for Rosie Y. For privacy reasons, the F.D.A. limits the amount of information that is made public. Using the short “Event Narrative” and “Manufacturer Narrative” attached to most of these 49 reports, we can piece together a few circumstances surrounding their deaths. Alone, each story makes little sense; gathered together, a much larger story unfolds.
When someone becomes ill, injured, or dies after they have a surgical implant, the manufacturers, importers and device user facilities are mandated by law to report the case to the F.D.A.’s MAUDE, (Manufacturer and User Facility Device Experience) database. In addition, health care professionals, patients and consumers are encouraged to make voluntary reports. (Instructions for filing a consumer report can be found here.)
The FDA MAUDE search tool is grossly limited. While it seems easy to search for “death” and “pelvic mesh” and find a complete list of all the people who died after pelvic mesh implants, it’s just not that simple. Words are misspelled; companies have two names or change names. Simply adding a location to the company name, such as Johnson and Johnson’s (J&J) Ethicon division does, will eliminate “hits,” so I must begin this report with this caveat:
“It is important to consider the multiple sources of potential error and bias in the underlying data.” It is my opinion that quantitative assessment of reporting rates to the FDA’s spontaneous reporting site (MAUDE) cannot be used to prove assertions about actual incidence rates for any events. However, after twenty-years of registered nursing (where I witnessed unreported events) and eight years spent supporting mesh patients with injuries, I believe the number of reports on the FDA database is greatly underrepresented and the real tragedy of surgical mesh: the debilitating illnesses and injuries, the deaths, hospital-acquired infections, surgeon errors, and suicides, is exponentially higher than MAUDE represents.
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On the first day of Summer, 2013, a woman underwent surgery for an anterior prolapse (sinking of the bladder or urethra into the vaginal wall). As the surgeon prepared to insert a Gynecare Gynemesh, the procedure required him to use a puncture needle to make a hole to secure a corner of mesh. When the surgeon punched the needle through her sacrospinous ligament, she began to bleed. The mesh was still lying on the Mayo Stand, ready to be implanted as she died. Try as he might, the surgeon was not able to stop the bleeding.
An Ethicon representative later wrote to the FDA about the event. With an air of cool detachment coming from someone who had not held her own breath while watching the woman on the operating room table slowly loose her color, see the nurses and doctors race unsuccessfully to save her, or sit beside the woman’s husband as he was told the devastating news. The Ethicon employee typed these stark words: “…but the patient was dead.”
The woman died three years after Ethicon pulled four other pelvic mesh products from the market while announcing it would continue to sell the one she was supposed to get. J&J wrote a letter to the FDA in 2010 stating “Ethicon also plans to update the product labeling for GYNECARE GYNEMESH® PS, including the Indication for Use, to restrict the indication for use to the abdominal sacrocolpopexy procedure (A surgical technique for repairing pelvic organ prolapse, an open abdominal or minimally invasive technique) for the treatment of pelvic organ prolapse.”
If Ethicon had pulled the Gynemesh along with the other four, would that woman still be alive? (Gynecare Gynemesh)
Twenty-four of the forty-nine deaths were associated with a pelvic mesh that was made by J&J’s Ethicon Division, nearly half the deaths we found. Of the 24, Ethicon’s Gynecare Prolift Pelvic Floor Repair Mesh and Tension Free Vaginal Tape Mesh were the most lethal, eight and seven deaths respectively. The patients I help say thought the Tension Free Tape was different because their surgeon assured them that a tape is not the same thing as “the one in the lawsuits.” Both are made of polypropylene, a substance that early scientists declared unfit for the human body and both involve surgery in a place where mother nature had better plans. Whether or not the design of the Prolift and the Tension Free Tape is directly responsible for the fourteen deaths is nearly impossible to prove because it just wasn’t investigated.
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Three other women died of hemorrhage. One woman, who also left her mesh behind on the Mayo Stand in the OR, was about to get a Prolift mesh. During the procedure, Ethicon noted, “the surgeon injured a large vessel” while he was performing a “finger dissection.” The surgeon was unable to stop the bleeding and gave her twenty units of blood trying to save her life. The device reporter, a little more compassionate than the one above, wrote, “unfortunately, she died on the operating table.” The company requested additional information but none was provided, so little more is known about the woman or her family.
One question lingers: how could a finger dissection tear open a major blood vessel when blood vessels are tough and fingers are covered by gloves? (Ethicon Prolift)
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A woman hemorrhaged and died on October 3, 2004 after receiving Ethicon’s Tension Free Vaginal Tape. Her surgeon knew she was on a potent a blood thinner medication and took precautions by putting her on the weaker anti-coagulant, clexane. Although surgery went well, the woman collapsed seven hours later. She was resuscitated once and taken back to surgery where the surgeon cut the tape in half and performed a Burch suspension (suspending the bladder by a strong suture, equally effective and less hazardous as synthetic mesh). Her surgeon removed over two quarts of blood but couldn’t find the source of the bleeding. After three days, she died of a heart attack (a blood clot to a heart vessel). Astoundingly, there was no autopsy so her story will never be complete. Clexane carries this warning: “Major hemorrhages including retroperitoneal and intracranial bleeding have been reported. Some of these cases have been fatal.” (Ethicon Tension Free Vaginal Tape)
Three years later, a woman had surgery to receive a Gynecare TVT (transvaginal tape) Obturator Mesh and her surgeon described her surgery as “successful.” After surgery, her abdomen became distended and her blood pressure dropped. A vascular surgeon could not find the source of her bleeding. She refused blood transfusions because of her religious preference and the next day she died. Although there was an autopsy planned, there is no MAUDE report with the result. (Ethicon Gynecare Transvaginal Tape)
I wonder if women who are in a very unpleasant situation, suffering from emotionally-charged embarrassment with pelvic organ prolapse or stress urinary incontinence, truly understand that death is a very real danger connected to pelvic mesh surgery. Would they still sign a surgical consent? Would their husbands so easily leave them at the door to surgery if they knew that, one day, this very hospital would serve as a reminder of their deepest loss? Would a woman walk out of her home one morning, mentally check if the stove was off and plan for her next Thanksgiving dinner, if she realized she might never walk again? Never have sex again? Never meet grandchildren? I wonder.
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Pulmonary embolism has long been feared and respected as a major risk of surgery. Today, the incidence of this tragedy has been markedly reduced due to changes and interventions in post operative care. People no longer linger in bed for two weeks–instead encouraged to get up and walk right after surgery. Compression stockings are applied and anticoagulant medication is given. Still, four of every thousand gynecological surgery patients have a pulmonary embolism.
On November 19, 2005, a woman received a Tension Free Vaginal Tape implant. Her MAUDE facts are scarce. She died a week afterward from a pulmonary embolism but no autopsy was done, yet Ethicon reports that her doctor did not think her death was related to the mesh. (Ethicon Tension Free Vaginal Tape)
March the thirteenth of 2010 was the another patient’s last day. She died of pulmonary embolism following surgery to implant both the Tension Free Tape and the Prolift devices. After surgery, she got up to urinate, felt weak, passed out and died. There was no more information offered on the MAUDE report. (Ethicon Prolift and Tension Free Vaginal Tape)
Another woman who died of pulmonary embolism had Coloplast Company product on January 25, 2013. The patient received a Restorelle® L synthetic mesh at some unknown date and later experienced a recurrence of her prolapse with the mesh exposed through her rectum. She had a pulmonary embolism, which lead to a fatal heart attack.
Before she died, her surgeon inserted a pessary ring into her vagina to treat the new prolapse. An x-ray revealed that her device had migrated away from her tailbone at the rear of her implant. The MAUDE report reads, “it was a pull-out of mesh from the anterior longitudinal ligament.” She had a surgery called a sacral colpopexy and was sent home from the hospital. On her way home, she became dizzy, short of breath, had chest pain, blurry vision and then passed out. Her heart stopped. She was resuscitated and admitted to the ICU but after two days, according to the MAUDE reporter, “the patient was made DNR (do not resuscitate) and her care was withdrawn.” She then died of pulmonary emboli (more than one) and a cardiac arrest. (Coloplast Restorelle® L)
A doctor was the MAUDE reporting party for the second of two Coloplast patients. This woman died of sepsis after a gruesome post operative course. To treat her vaginal prolapse and fix her enterocele (posterior vaginal hernia), she was implanted with one of the Restorelle products. She went home with no apparent problems but soon returned with a fever, nausea, vomiting and diarrhea. A CT showed she had a pelvic abscess which was drained. Soon after, she her blood pressure dropped to a dangerous level and she was transferred to the ICU in septic shock.
Surgeons tried to help by removing the vaginal mesh and took out all of the necrotic (infected and dead) tissue—she lost part of her vagina. Despite the interventions, her sepsis continued. Surgeons again took out more dead tissue, rerouted her intestines to a colostomy and implanted a Wound VAC (a somewhat painful device to drain serous fluid and blood and close the wound). Within days, she was only alive because of the assistance of a mechanical ventilator. She developed pneumonia. Sadly, her family felt it best to ask the doctor to take her off the ventilator. She died on May 13, 2012. (Coloplast Restorelle®)
Sepsis is a serious and often life-threatening condition with the presence of bacteria (bacteremia), other infectious organisms, or toxins created by infectious organisms in the bloodstream with spread throughout the body. On Oct 19, 2007, one woman had a sacral colpopexy done in conjunction with the implantation of Ethicon Gynecare Gynemesh PS Mesh. Her manufacturer reported to MAUDE that the surgery was “uncomplicated and easy.” (One wonders, for whom?) About six or eight hours after surgery, her blood pressure dropped and, suspecting she had aspiration pneumonia, doctors put her on antibiotics. After a rough ten-day course in the hospital, they finally discovered she had a bowel perforation—not pneumonia. Her colon was removed and her rectum closed. During that surgery, doctors found she had an infected hematoma “up the right side colic gutter” (slang for parabolic gutter: one of two open areas between the wall of the abdomen and the colon). The woman died two days later and the cause of death is reported to be, “multiple organ failure from sepsis due to a bowel perforation related to the surgery.” It all started with her pelvic organ prolapse. (Ethicon Gynecare Gynemesh PS Mesh)
Three years later, on 06/28/2010, another woman had an eerily similar experience after an Ethicon Prolift+M Pelvic Floor repair. J&J’s representative reported that her bowels and bladder stopped working one day after her surgery. An ultrasound was done and they found a tennis ball sized blood clot. Surgeons operated again suspecting her colon had been nicked and, sure enough, found part of the mesh, the right posterior arm, had been attached to her sigmoid colon (a grave and life-threatening surgical error). Tragically, the surgeons felt she was in too fragile a condition to withstand a removal of the arm so she was treated with heavy-duty antibiotics and sent home.
She was rushed back for an emergency admission in grave condition with septic shock. She was resuscitated and placed on a ventilator, underwent one more surgery, but did not make it. Her official cause of death was, “multi-organ failure with urosepsis.” (Ethicon Prolift+M Pelvic Floor Repair)
The manufacturer’s representative who reported this incident to MAUDE must never have been in the room with a family while the doctor carefully chooses his words to deliver life-shattering news; never watched taut shoulders suddenly drop, or lips quiver as family members wait for the doctor to finish the most horrific sentence they’ll ever hear—as if they know what he’s going to say but keep hoping won’t he won’t say it. The risk manger who sent this report probably never felt her own shoulder turn wet and warm while she held a patient’s sobbing adult child, trying to keep them from collapsing to the floor under the unbearable weight of their grief. Never heard a daughter sob and ask, “What do I do now?” and silently struggle for an answer. Never heard the loud, deep, long, guttural sound of a devastated loved one resounding through her own body and down the hallways of the hospital—a sound that would ring in her ears throughout the rest of her day. Never walked softly through the remainder of her shift, carrying her own grief for her patient as she emptied bedpans for her others.
Ethicon’s rep just did her job. She took shortcuts as she wrote her testimony of this woman’s disastrous death. Here it is exactly as it appears on MAUDE,
…“the device instructions for use warn ‘use the gynecare prolift+m systems with care, and with attention to pt anatomy and to proper dissection technique, to avoid damage to vessels, nerves, bladder, bowel and vaginal wall perforation. Users should be familiar with surgical procedures and techniques involving pelvic floor repair and synthetic meshes before employing the gynecare prolift+m systems.’”
A fisherman casts his fishing net on the coast at sunset Gabon
Of all the reports we found, only one was written by a civilian. It was written by a son who watched his mother go downhill, tried everything within his power to stop her downward trajectory and is, to this day, is haunted by her suicide. He aggressively continues her fight against the use of synthetic surgical mesh.
I’ll let you read his own words:
“My mother had the Johnson and Johnson Gynecare Prolift (posterior) Repair system and the Uretex Synthetic Sling implanted on [date redacted by FDA] 2008. Approximately four months ago, she started having problems such as erosion out of her vagina with severe pain. She was going weekly to have her bladder flushed with antibiotics because of erosion into her bladder too. She was having severe constipation problems believed to be associated with the sling. She tried pain pills but they would not help with the pain. She would set up in bed laying across several pillows begging for relief. My mother was in such pain that she went in the backyard and shot herself. She is now gone due to the FDA (allowing) this mesh to be put in women. Reason for use: prolapse. Just given a prescription for pain.” (Gynecare Prolift (posterior) Repair system and Uretex Synthetic Sling)
* * *
Ethicon’s MAUDE risk managers often copy and paste phrases from one report to another. Here is an example: “Conclusion: no conclusion can be drawn at this time. Should additional info be obtained, a supplemental 3500a form will be submitted accordingly.” The 3500a form is a voluntary report.
* * *
Other women whose deaths are memorialized by MAUDE include:
• 1/25/2010 – One whose had a sponge left inside by her surgeon, an all too frequent surgical error. The surgeon went back in and removed the sponge but left the mesh inside her. She went home where, after a few days, she collapsed and died of a pulmonary embolism. (Ethicon Prolift+M)
• One who had a heart attack the day after her surgery. Her surgeon said it was unrelated to her surgery. (Ethicon Prolift)
• One who developed a massive strep infection (necrotizing faciitis) in the days after surgery and had her mesh and much of her vaginal tissue removed. She soon died from the infection. All bodies carry strep. The very brief MAUDE report mentions her body carrying strep, but does not link her massive infection to the surgical technique used to implant the tape. Her mesh was implanted by dragging it through her vagina, an area considered “clean contaminated” and impossible to sterilize. (Ethicon Tension Free Vaginal Tape Mesh)
• In 2005, no autopsy was performed after a woman who developed excessive bleeding six weeks after a transobturator bladder sling (TOT) implant died. Despite the lack of investigation, the report says, “ physician indicated that the obtape sling did not contribute to the patient’s condition.” (Mentor Corporation Obtape Sling Transobturator)
• Another woman who had a TOT, knew right away she had a big problem. She had “excruciating pain” and couldn’t pee which lead to multiple bladder infections and eventually to sepsis just before she died.
[Take note: the name of the product in the FDA report was misspelled as “Oburator”—it would not pop up in a MAUDE search engine if the user searched for “Obturator.”] (Ethicon, Inc. Gynecare TVT Obturator System Mesh)
• In July of 2005, a Risk Manager from a “User Facility,” (hospital, outpatient diagnostic or treatment facility, nursing home or ambulatory surgical facility) reported the death of a woman who died three days after getting an obturator tape. The day after her surgery, she was feeling “punky” and was told to stay home and take over the counter medications for pain and fever. The following day, she was rushed to the ER in full sepsis, put on a ventilator, and died the day after. The cause of death: “Overwhelming sepsis of undetermined etiology, acute renal failure, metabolic acidosis, and ARDS.” The reporter added: “Autopsy=no spesis (sic) source identified, all postmortem cultures negative.”
This woman’s case got some additional attention. There are three “Event Descriptions” for her, each a little different and all seemingly written in haste; descriptions included multiple misspellings, grammatical and typographical errors, and casual abbreviations. The second report added dates to the first. The last one, which appears to be written by the same author, is copied here without editing: “company’s original communication stated ‘during normal course of design verification, co has concluded material mediated pyrogenicity studies in rabbits for the device. All results have been positive. Generally co would only conduct a lal test to confirm a positive mm pyrogen study. As none of the tvt tests have shown positive mm results, company does not have lal results available for the tvt.’ The use of the term ‘positive’ in the second sentence was in conflict with it’s use later. The use of ‘positive’ was meant to mean the tests passed, i. e. Did not have a pyrogenic result. A more appropriate statement is ‘all test results have shown no pyrogenic response.'”*
One only has to wonder how her family might feel after they read Ethicon’s narrative noted above. (Ethicon Gynecare TVT System Obturator)
* Author note: Pyrogenic means producing or produced by fever. The MM, or Material Mediated Pyrogen Test, is used to determine whether a saline extract of a medical device causes a pyrogenic response (fever) in rabbits. LAL test is endotoxin testing to ensure injectable therapeutics are safe for human use.
Peggy Day is working on a book to combine all these stories. She welcomes any input you may have.
If you’d like to join an online support group and learn about erosion, partial removals, surgeons, or just find out that you are not alone, check the list of support groups here.
Subscribe to PelvicMeshOwnersGuide.com to learn more about pelvic mesh. I’d like to hear from you if you are helped by what you read here or if you need to know more about any particular topic. Comment below or email me privately at firstname.lastname@example.org.
This blog contains first-hand opinions about pelvic surgical mesh from a calliope of experience: from 8 years of meetings, phone calls, emails and social network with mesh victims, interviews with surgeons, years of front-line emergency nurse work and early work in biostatistics and medical research, to walking the mesh walk today. I’ve learned about the magnificent inner strength of women facing unparalleled and unimaginable pelvic injuries and, along with it physical, emotional, social and spiritual challenges that would buckle the knees of the bravest soldier. These women inspire me in their tenacity and unwillingness to let go of the true joy in their lives.
To those women, I dedicate this blog.