Category Archives: Wound Infections

Pelvic Mesh: How People Died

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.”


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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.

* * *

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.

* * *

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)

* * *

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.

Mesh is for screens 2                                       * * *

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

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 daywriter1@gmail.com.




22+ Crucial Questions to Ask Surgeon Before Mesh Surgery

 1. What is the operation being recommended? Is it necessary?

 2. Why is the operation necessary?

 3. I am aware that a bladder sling or hernia mesh is made of polypropylene and the material is the same, whether it is called a “tape” or “minitape.” I do not want polypropylene in my body. Are you willing to do the surgery without the use of synthetic surgical mesh? {__ I am allergic to polypropylene (check if applies to you).}

4. What are my alternatives to this procedure? (for example: I am aware the Burch Procedure has the same rate of success as synthetic surgical mesh. Are you able to do an alternative procedure)

 5. What are the benefits of the surgery and how long will those benefits last?

 6. What are the risks and possible complications of having the operation?

 7. What are my possibilities if I choose not to have the surgery?

 8. How many of these surgeries have you performed?

9. For which specialty do you have a board certification?  Urology, Urogynecology, Gynecology, General Surgery, Colorectal Surgery?  Other?

10. Where will my surgery be performed?

11. How long will my operation take?

12. Why type of anesthesia will be administered? If it is not a hospital, is there emergency equipment if I should have trouble with anesthesia? What is the plan for emergencies? 

13. What type of incision will be used? Will it be an open procedure, minimally invasive or laparoscopic?

14. Do you have to cut close to larger nerves to complete this operation?

15. What are my chances for getting new nerve damage?

16. What is the risk of mesh erosion into healthy organs from this surgery?

17. What are my chances for getting a wound infection? What is the hospital’s nosocomial infection rate? Do you provide antibiotic prophylaxis?

18. What are the specific risks of this procedure?

19. What will my operation cost? What else will I be charged for?

20. What can I expect during recovery?

21. How will my life be changed for the good or bad after this operation?

22. How many future surgeries might I expect after this surgery if there are complications?

Added question: Are you planning to have a salesmen in the operating room with you? I do__ do not___ prefer to have a sales representative in the OR with me.

(Click here for download of copy with fill-in-the-blanks.)


 

 POLY IS FOR ADA RAMPS


 

Places to check-up on your surgeon

It is important to have confidence in the doctor who will be doing your surgery and you can make sure that he or she is qualified. Each state licenses its physicians. Take the time to search for:

       “[Name of State] physician license verification” for your own surgeon.

Make sure to check for disciplinary actions taken or whether the license is current. Example here.

  • Ask your primary doctor, your local medical society, or health insurance company for information about the doctor or surgeon’s experience with the procedure.
  • Make certain the doctor or surgeon is affiliated with an accredited health care facility. When considering surgery, where it is done is often as important as who is doing the procedure.

From PelvicMeshOwnersGuide.com                        © Peggy Day November 27, 2015





25 Crucial Questions to Ask Your Mesh Removal Surgeon

1. What is the operation being recommended? Is it necessary?

2. Why is the operation necessary?

3. What are my alternatives to this procedure?

4. What are the benefits of the surgery and how long will the benefits last?

5. What are the risks and possible complications of having the operation?

6. What are my possibilities if I choose not to have the surgery?

7. How many of these surgeries have you performed?

8. For which specialty do you have a board certification?  Urology  Urogynecology  Gynecology √ General Surgery  Colorectal Surgery?  None Other 

9. Where will surgery be performed?

10. How long will my operation take?

11. Why type of anesthesia will be administered? If it is not a hospital, is there emergency equipment if I should have trouble with anesthesia? What is the plan for emergencies? 

12. What type of incision will be used? Will it be an open procedure, minimally invasive or laparoscopic?

13. If mesh is embedded in my bladder or urethra, do you have the skills to take it out?

14. If mesh is embedded into my obturator spaces, do you have the skills to take it out?

15. If mesh has eroded into my colon or rectum, do you have the skills to take it out?

16. If I have more than one mesh, do you have the skills to find it and take it out?

17. If mesh is close to a blood vessel, do you have the skills to remove it?

18. If mesh is close to a large nerve, do you have the skills to remove it with the least amount of damage?

 19. What are my chances for getting new nerve damage?

 20. What are my chances for getting a wound infection? What is the hospital’s nosocomial infection rate? Do you provide prophylaxis to address biofilm-related infections?

21. What are the specific risks of this procedure?

22. What will my operation cost? What else will I be charged for?

23. What can I expect during recovery?

24. What are the ways will my life be different after this surgical procedure?

25. How many future surgeries should I expect?

(Click HERE for Printable Version with Fill in the Blanks.)


Mesh is not for bodies in motion

Places to check-up on your surgeon

It is important to have confidence in the doctor who will be doing your surgery and you can make sure that he or she is qualified. Each state licenses its physicians. Take the time to search for:

       “[Name of State] physician license verification” for your own surgeon. Example here.

Make sure to check for disciplinary actions taken or whether the license is current.

  • Ask your primary doctor, your local medical society, or health insurance company for information about the doctor or surgeon’s experience with the procedure.
  • Make certain the doctor or surgeon is affiliated with an accredited health care facility. When considering surgery, where it is done is often as important as who is doing the procedure.

 


 

  • 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 daywriter1@gmail.com.


26 Pelvic Mesh Complications Your Doc Never Mentioned

Welcome to the Pelvic Mesh Owner’s Guide! This page is like a Table of Contents.

Over 4.2 million women have the implants and a quarter to a third of them suffer debilitating complications while doctors say, “It’s not the mesh.” The FDA warned in both 2008 and 2011 that complications are serious. Too many women are finding out they were right all along, it is the mesh. 

If you’re having trouble with mesh, here is a list of 26 complications in the Pelvic Mesh Owner’s Guide. Sign up for updates to learn more and take the first step on your healing journey.

POLY IS FOR CABLES copy

26 Mesh Complications Your Doctor Never Warned You About:

1) Intractable Pain (pain that doesn’t go away) – Some people wake up from implant surgery knowing something is wrong. It is too tight or the pain is beyond measuring. Part 1 talks about the post operative pain from pelvic mesh & Part 2 is one woman’s journey with pelvic mesh pain.

2) Excessive BleedingBleeding happens but when is it too much? When to call the doctor? How to regain strength after heavy bleeding

3) Urinary tract infection, Kidney infection – Urinary tract infections are serious health-risks and can involve the bladder and kidney. When mesh is stuck in the bladder it continually irritates the bladder until it is removed surgically. Learn how to prevent UTIs and test yourself at home and to distinguish a bladder infection from a kidney infection.

     4) Wound infectionsA bladder sling can act like a petri dish harboring and incubating strong, sometimes drug-resistant bacteria. Left undiagnosed, they can lead to a delay in wound healing, even open up wide and deep surgical wounds and putting your life at risk.

5) Bladder injuryA slip of the knife, a puncture from an ice-pick like trocar, sling pulled so tight that it cuts the bladder. A bladder injury is one of the most difficult to repair. One study says it happens 10% of the time, another say 75%!

6) Bowel InjuryWhen a part of the bowel is nicked, fecal matter seeps into the interior of the body, when it the diagnosis is delayed or completely missed, patients become extremely ill.

7) Fistula (a hole between two organs) – Imagine your urine draining out of your vagina or your stool coming out. Fistula is all to common and deeply embarrassing for women.

8) Wound Opening Up After Stitches(also called dehiscence) – You think your surgery is healing and you are trying to get back on your feet and back to normal. Then your wound starts to open up. Dehiscence delays healing for a very long time.

9) Erosion – (also called exposure, extrusion or protrusion) As many as one patient in three experiences erosion from mesh. Would you agree to mesh if you were told the odds that you wouldn’t enjoy sex ever again were one in three?

10) Incontinence “I sneeze, I pee.”The odds that mesh surgery won’t cure your incontinence is the same as other surgical repairs: one in three.

11) Urinary Retention “I can’t pee right.”A mesh that is implanted too tight can slow down or stop your urine stream for about four percent of patients. Why does your surgeons “handedness” (right- or left-handed) affect your outcome?

12) Dyspareunia – pain during sexual intercourse One study found 26% of women found sex too painful after mesh surgery.

13) Multiple surgeriesWhen things go wrong, often the solution is another surgery and another. Some women have had over a dozen surgeries to correct mesh complications. More surgery = more scarring.

14) Vaginal scarring/shrinkage – Vaginal scarring: one of the most emotionally and physically difficult problems to heal.

15) Emotional DamageNaturally, an injury to a woman’s re-creative center causes emotional pain but can we allow doctors to blame the women?

16) Neuro-muscular problems – nerve damageStinging, burning, pins-and-needles, numbness all are signs of nerve damage. Even the way your body was positioned during surgery can cause nerve damage.

17) Obturator Nerve – Symptoms in your mid-thighs (saddle region).

18) Ilioinguinal/iliohypogastric Nerve – Symptoms in your pubic region.

19) Genitofemoral Nerve – Symptoms in your inner groin.

20) Femoral Nerve – Symptoms in your outer thighs

21) Pudendal Nerve Entrapment – Symptoms in your “sit spot.”

22) Fibular Neuropathy – Symptoms on the outside lower legs

23) Saphenous Nerve – Symptoms on your inner lower legs

24) Piriformis Syndrome – Symptoms across your buttocks.

25) Sciatica – Symptoms all the way down your leg.

26) Peripheral Neuropathy – Symptoms from the bottom of your feet and up your legs, even your hands can be involved.

MESH IS NOT FOR BODIES 2


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 daywriter1@gmail.com.

Did a Salesman Oogle Your Pelvic Mesh Surgery? – Salesmen in the OR

You may be surprised to learn just how your doctor purchased the pelvic sling he put in your body. Truth is, he didn’t have to lift a finger. His sales rep brought it to him. Moreover, there is a good chance your salesman watched your doctor put it in you and, he may even have “scrubbed in” and performed part of your surgery.

It is no accident that your surgeon “forgot” to mention the manufacturer’s rep might be in your surgery. Manufacturers are well aware that the practice is very controversial and don’t want you to know. David S. Hilzenrath discovered the obfuscation while preparing for his 2009 Washington Post story about salesmen boosting sales by participating in operations:

“(S)ome companies want nothing to do with a story about sales rep in the operating room.
“‘I would hope that you would not mention Boston Scientific in your story,’ a spokesman for that company e-mailed.
“Major device makers such as Johnson & Johnson, Stryker and Zimmer declined to arrange interviews for this article.”

POLY IS FOR ELECTRIC WIRES

Mesh injured women began realizing that manufacturers invaded their surgeries, not when they were asked to sign a consent for an observer to be there while their genitals were being operated on, but afterward when they found evidence by reading their own charts. Detail men around the world routinely attend surgeries to make sure doctors don’t use competitors’ products.

In 2008, Ronda Yancy (not her real name) was appalled when she retrieved her own medical record: “I found out, after my surgery, that a Johnson & Johnson Gynecare sales representative was in the O.R. with me.”

Yancy, who died at 52, after living her final years dealing with mesh complications and a string of illnesses, had been implanted the Gynecare Prolift (a polypropylene-based surgical mesh device used to treat pelvic organ prolapse). The Prolift was first introduced by J&J in 2005 without an F.D.A. approval and was soon the source of alarming federal complaints. It wasn’t removed from the market until a year after Ronda’s death, in 2012.

Ronda’s pelvic sling sawed itself out of the space it was supposed to be and into her vagina, causing her suffer years of infections and disabling pelvic pains. “I sure never thought that some day I’d be crying just cause I can’t stand to wear underwear anymore, much less pick up my grandkids,” said Ronda. “After the surgery I couldn’t walk properly and am in constant cutting pain. Doctors say I am the first patient to ever have problems.”

After Ronda posted in an online support group, others began to look at their operative reports and at least three found that salesmen had been in the room with them while they slept. One said she felt like she’d been “drugged and raped.”

One nurse wrote to the group, “The hospital loves for the reps to come in because their labor is free and they provide free products to use. The reps bring in pizza dinners and cater lunches from time to time and so the O.R. staff loves them too.

Trendelenberg

Jack-knife position for vaginal surgery. (Posed by clothed woman)

Bill Mackay, a high school drop-out and device salesman who performed the major part of a surgery that crippled a man in 1975, was never mentioned in that patient’s chart. He later wrote in a tell-all book, Salesman Surgeon, that he took over lead surgeon, David Lipton’s position during a hip replacement, ordered the nurse to hand him sharp instruments, hammered and chiseled away at bones and removed one hip prosthesis and implanted another. He said it was the “one of nicest pieces of surgery (he’d) ever seen or done”  but the patient, Franklin Mirando didn’t agree. The forty-two-year-old service station owner never walked again after Mackay was done with him.

In 1977, criminal charges for assault and misrepresenting business records were made against salesman Mackay, two surgeons, a nurse and the Smithtown General Hospital. Investigations were launched by both state legislators and the Sulfolk County Medical Society. Despite all the hoopla, the charges were eventually dropped and the manufacturers across the country began to have free rein inside operating rooms.

What could possibly go wrong when you send wet-eared salesmen into an operating room? In 1998, another device rep was sued after he operated a machine during a fibroid removal surgery and 30-year-old Lisa Smart died within hours. Lawyers found Lisa’s surgeons had botched many aspects of her surgery including overloading her with fluid. She drowned. Her husband’s lawyers were also shocked to discover Johnson & Johnson sales rep, David Myers, was operating the dials on the unauthorized machine that delivered electrical impulses to her uterus. “The patient was never given the chance to consent to the use of the equipment or the presence of the salesman,” the New York Times reported at the time. The hospital a was fined $30,000 and Myers disappeared from sight. Yet again, in the face of another disastrous outcome, device marketers stepped up their pace.

Classes for prospective salesmen include topics like: “how to get inside a surgical suite without an invitation” or how “to sell without making the surgeon feel that he’s being sold” or even “the art of engaging surgeons in conversation.”  Candidates are invariably young, good-looking go-getters whose training lasted no longer than a few weeks. Although a college education is recommended, it is not always required. Despite the fact that pelvic mesh sellers are given an unfettered view of your genitals, there is no evidence that they were ever required to go through a background check–although your nurse sure was.

bathing-machine-with-men-ogling-women

Recently, two pelvic mesh recipients found out that salesmen had been with them by reading their charts. One woman noticed a set of unfamiliar initials next to “Ass.,” or assistant surgeon, on her operative report and set out to investigate. She found another document with the full name spelled out and remembered her surgeon mentioning he was going to “ask the advice” of his salesman with the same name. She was never told he would be there. A modest woman, she can’t digest the fact that a total stranger was afforded a clear view of her most private area. As if to compound the emotional harm from realizing a salesman had seen her tilted backward, legs spread on an operating table, she said the same sales rep later visited her in her home–right after she made an official complaint about her mesh injuries.

It the manufacturers are working hard to hide the presence of salesmen in operating rooms, there is no way to know if, when your transobturator-tape was pulled to tight, it was really the detail man who tugged too hard on that trocar or if his scrubbing technique was not up to standard and that’s why you had a post-operative infection.

If you would like to look up your medical record, be prepared to put a little wear and tear on your shoe leather. Go to your hospital medical record department in person and ask for the complete report of your surgery, including the label for you implant. Most medical record departments provide only the surgeon’s dictated report, especially when you ask by mail, but there is a lot more paperwork than that. Look for your consent, your anesthesiologist’s minute-to-minute accounting, your nurse’s count of sponges and instruments, and your interoperative report, which should contain the names of everyone who attended your surgery.

Yancy felt she was invalidated every step of the way after her implant. Doctor after doctor told her, “Mesh is the gold standard, it can’t be the mesh.” She summed it up in one word saying she had been “Gaslighted,” a reference to the 1944 movie, Gaslight, in which Charles Boyer pulled dirty tricks on Ingrid Bergman and then told her she must be going crazy–all the while pretending he had her best interest at heart. What a perfect phrase. Are you being Gaslighted?


Peggy Day is working on an investigative report on pelvic mesh salesmen in the operating room. She welcomes any input you may have about the questionable practice.

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 MeshTroubles.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 daywriter1@gmail.com.

Signing Up For Just One Surgery With Pelvic Mesh?

Imagine this: Two women had tree branches fall across their homes causing major damage. Both trees did the most damage to the kitchen. Cindy Lu hires the guys who promises to get the job done the fastest for the least money. Her contractor comes in one day, and chops out the middle of the branch and cleans up the mess on her kitchen floor and replaces her kitchen faucet so it will run. He gets the job done in less than a day. Karen hires a more experienced contractor who takes out the entire branch and repairs all her plumbing, appliances and replaces her furniture and cleans up every tiny piece of bark or wood chip. It takes several days. He comes back later on and fixes the broken walls, windows and doors and returns her home to as close to pre-storm conditions as possible.

Which contractor would you hire?

This is an analogy to what happens when pelvic mesh goes bad. The surgeon who chips away at pelvic mesh, one eroded bit at a time, sets up a patient for multiple surgeries— today’s mesh trouble. Recently, Linda Gross won over 11 million dollars at trial after 18 surgeries to repair erosion, scarring, and tissue damage from a Gynecare Prolift pelvic sling. Surgeries performed after the pelvic mesh implant correct erosion, new or continued incontinence, difficulty urinating, infections, scar tissue, pain, deheisance, or fistulae. Women experiencing generalized symptoms they attribute to mesh opt for removals as well and report an improvement in their symptoms.

MESH IS FOR LAUNDRY

Synthetic surgical pelvic mesh was first thought to be faster, easier and better than traditional repairs like culpopexy and porcine and native tissue sling repairs. Newer research says it  just wasn’t true.  In a 2013 review, authors concluded that, even though sacral colpopexy had a longer operation time: “the sacral colpopexy had a higher success rate on examination and lower reoperation rate than high vaginal uterosacral suspension and transvaginal polypropylene mesh.”

Mesh removal is risky business due its faulty design. Absent-minded scientists have been accused of not stepping back and looking at the “big picture” ever since Thales, the Greek mathematician, looked up at the stars so often that he fell down a well. Designers of pelvic mesh imagined they found the best thing since the flat turret lathe or bifocal eyeglasses. It was so perfect, they must have thought, nobody would ever want to remove it.

It is an interesting observation that more doctors are prone to diagnose only what they can see—on your body, an x-ray, in a lab report then by the patient’s description of her problems. Headaches, backaches and now pelvic pain are the least recognized and treated medical complaints today. Until the “BLUE sh*t” (as Johnson & Johnson execs called Gynecare mesh in a secret email) could actually be seen by the doctors, women’s complaints were ignored. If they got an answer from their doctors, they were advised to have it snipped, dissected, ligated, trimmed or revised. When the mesh kept sneaking back, surgeons removed more little bits.

It takes a highly skilled surgeon like Dr. Shlomo Raz at UCLA to remove all of the mesh, including the anchors (secured ends).  The few surgeons who do remove the mesh in its entirety complain that removing all of shards of mesh from healthy human flesh is like getting bubblegum out of hair.

Dr. Dionysios Veronikis of St. Louis, MO invented a surgical instrument that  dissects the mesh away from the healthy tissue without cutting surrounding structures. He finds one end of the mesh and then carefully cuts, moving his instrument forward until it frees up the entire sling in one piece. It is hours and hours of painstaking work and healing from the procedure takes a long time.

Once mesh is removed, more surgeries are often needed to revise the damage left behind and fix structural problems. Complications, like bleeding, infection, and nerve damage, from mesh removal surgery are common. After finally going through removal surgery, 87% said they would never have had the artificial mesh implant in the first place, if they had only known. If you’ve not yet had an implant, you are one of the lucky ones because, now that there is more research and information is available on the net–mesh does not appear to be easier or better. Many, if not most, doctors are reverting to traditional fixes. You can save yourself a boatload of trouble by finding a surgeon who can repair your problem without mesh.

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 MeshTroubles.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 daywriter1@gmail.com.

Why Wound Infection After Pelvic Surgery Is So Much Worse

Besides holding your healing process back, a surgical wound infection can make you very sick, disfigure you, create fistulas require more procedures and surgeries or make a mess of your plans for the future. Synthetic surgical mesh intensifies your risk of infection after surgery because it drags bacteria into the deep recesses of your body and then acts like an over-generous host, allowing several difficult and stubborn types of bacteria to grow and multiply on its surface. Manufacturers have adamant about changing the mesh composition rather than finding a more natural and less toxic remedy for SUI (stress urinary incontinence) and POP (pelvic organ prolapse).

A surgical site infection is a nosocomial infection (hospital-acquired) that can occur within 30 days after surgery. Mesh-related infections, the most common complication after mesh surgery, cause “significant morbidity,” which, in plain English, means it makes you sick, very sick and for a long time. Nosocomial infections come under careful scrutiny by the State and Federal agencies. Over 3 million people have mesh inside their bodies and many of them want it taken out. However, the danger of stirring up the “germ soup” surrounding mesh implants should be considered before planning pelvic mesh removal surgeries.
While wound infection is a complicated topic, today blog offers an overview and links to a few articles about pelvic infections from established medical journals. You are welcome to print them and take to your doctor.

MESH IS NOT FOR BODIES 3

Cause: The environment in your vagina is different from the what’s on your skin—where most surgeries begin. Even when the cut is made abdominally, through your skin, for transvaginal mesh surgeries, the connection with your vagina is made inside your body. That makes you more vulnerable to the kinds of bacteria that like to live inside your vagina. Some vaginal bacteria hate light and love warmth so when they get pushed inside the deep pelvic spaces they continue to thrive and cause trouble. They form a bacterial wall called a biofilm on the surface of the mesh where the body’s natural defenses can’t reach. There are often several different bacteria causing a post-op pelvic infection, and these may include: gram-negative bacilli, enterococci, group B streptococci, and anaerobes.  (More on those in a later blog.)

Types of pelvic surgical site infections: The three most common post-operative pelvic infections are vaginal cuff cellulitis, pelvic cellulitis, and pelvic abscesses. The infections, in order of severity, can be superficial, deep, or within the organ space.

A superficial infection, vaginal cuff cellulitis, involves the skin and subcutaneous tissue (just under the skin). You may feel pain or tenderness, localized swelling, redness, or heat over the area. Deep infections, pelvic cellulitis, involve the fascia, muscle, etc. You may have thick, yellow or brown drainage the wound, a spontaneously dehiscence or your surgeon may deliberately open your wound to allow drainage, fever over 100.4F (>38°C) degrees, pain in the surgical area, or tenderness. Lastly, you may  have a deep abscess, pelvic abscess, requiring drainage. Infections involving organs and spaces around organs produce purulent (containing pus) drainage from a surgical drain, abscess, and include the signs of infection above.

Tests used to identify the extent of the infection include a thorough examination by your surgeon, or radiological exams like ultrasound, CT (computerized tomography), MRI (magnetic resonance imaging), or exploratory surgery. Your surgeon will probably take a culture of the wound to find out which bacteria is causing the infection and to prescribe the right antibiotic(s).

Risk Factors: You may be at greater risk of developing a post-op infection if you have diabetes, especially if your blood sugar goes over 150 mg/dL just before and after surgery or your hemoglobin is over 6.5% just before surgery. Other risk factors include obesity, (BMI> 30), anemia, prior strokes, tobacco, steroid use (like prednisone), malnutrition, increased age, prior radiation treatment to the site, or vaginal infection. The longer you are in the hospital before your surgery, the higher your risk for post operative infection.

Let your doctor know if you’ve had any recent bacterial infections. When you minimize your risk factors, you lessen your chance of getting a post-op infection.

Pre-op antibiotics: Before the invention of a process of giving pre-op prophylactic antibiotics, as many as 33 percent of patients ended up with pelvic infections. After prophylactic antibiotics were introduced, the number of infections dropped to 2.7%. Before pelvic surgery, ask your surgeon what is the plan for your antibiotic prophylaxis.
The most common prophylaxis follows the American Journal of Health-System Pharmacy recommendations: Cefazolin be given within an hour before or hour after the first incision. If the surgery goes longer than 3 hours, they repeated doses. Larger doses to be given to women over 265 pounds (120 kilograms). Chart of antibiotic guidelines here: Table 1  and Table 2  If you are allergic or resistant to one antibiotic, other ones can be given. Table 3 is a list of recommended antibiotics for pelvic mesh surgery infections separated by depth of infection.

If you are suffering from a pelvic surgical infection, take gentle care of yourself. Plan to rest, and take plenty of non-caffeinated, low- or no-sugar fluids. Eat the foods your mother made you finish: fruits and vegetables, proteins. Take multiple vitamins. Gather around you your most nurturing friends and relatives and send any annoying visits out to run errands. There are several support groups you can join to gather encouragement as you go through the long and slow process of of healing. May it be rapid.

We’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 at daywriter1@gmail.com.
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12 Pelvic Mesh Common Complications That Should Make You Think Twice

Plastics and human flesh, what could possibly go wrong? Ever since the day you had mesh implanted, you’ve had no end of troubles but your doctor says, “It’s not mesh related.”

Severe and life-threatening mesh complications are more frequent and widespread than doctors realize. Here are a dozen mesh problems that women have reported to the FDA:

    1.    Excessive Bleeding
    2.    Infections:    
            ⁃    Urinary tract infection, Kidney infection
            ⁃    Wound infections
    3.    Organ perforation
            ⁃    Bladder injury
            ⁃    Bowel Injury
            ⁃    Fistula (a hole between two organs)
    4.    Wound Opening Up After Stitches –  (also called dehiscence)
    5.    Erosion – (also called exposure, extrusion or protrusion)
    6.    Bladder problems:
            ⁃    Incontinence “I sneeze, I pee.”
            ⁃    Urinary Retention “I can’t pee right.”
    7.    Dyspareunia – pain during sexual intercourse
    8.    Intractable painPart 1 & Part 2
    9.    Vaginal scarring/shrinkage
    10.   Emotional Damage
    11.    Multiple surgeries
    12.    Neuro-muscular problems – nerve damage
              ⁃    Can’t sit down
              ⁃    Can’t walk
              ⁃    Wheelchair bound

mesh is for badminton2

Most of these complications will require additional intervention, including medical or surgical treatment and hospitalizations.

About complete/full removals vs partial removals:

I think it is crucial to let you know the best best surgeons are saying that a complete removal of pelvic mesh is the only solution.  This is not the usual or accepted intervention done by most medical centers. We will concentrate on this very soon, but know this: in January of 2011, the National Institute of Health published this statement. “Complications seemed to be more frequent in the group with complete mesh excision, although this difference was not statistically significant.” I strongly recommend you print it out and take it to your surgeon when you are discussing solutions to mesh problems. Tell him/her that complications from complete removals are not statistically different from chipping away at the problem, setting up the patient for multiple surgeries and thereby spreading toxins and infections.

Please send questions or urgent problems by email to daywriter1@gmail.com Meshtroubles.com #pelvisinflames @daywrites