Category Archives: Neuromuscular Injury

Pudendal Nerve Injury Caused by Improper Insertion of TOT Obturator Tape – Pelvic Pain

The two main nerve complications TOT-injured women report in support groups are 1) pudendal and 2) obturator in that order. Because most studies do not evaluate for nerve injuries past 3-12 months, there is no scientific estimate of how common the injury is. Our experience is that it is extremely common. Pudendal injury causes persistent pain localized around the urethra and around the clitoris, irradiating to the one labia majora (maximum at the lower edge of symphysis) or both.

Polypropylene creates cripples when placed inside the pelvis.

The pudendal nerve is nowhere near the pathway of an obturator tape so how did the women get injured? The mystery may have been solved by three Czech investigators.

In 2011, Jaromir Masata & Petr Hubka & Alois Martan decided to look into why their patient, a 48 years old female obtained a pudendal nerve injury. After receiving a TVT-O, the woman experienced what the authors saw as an “atypical” postoperative pain that continued without relief for three years. While the authors treated her with injections and replaced her sling with yet another dubious tape, the work they did to track down the cause of her injury is valuable.

Authors circled scar and placed a “+” pointing to correct placement location.

The woman’s insertion scar (see Figure 1) was in the wrong place. By using a cadaver to trace the aberrant passage of her sling, the researchers found it intersected with the pudendal nerve. How many others were injured this way? Are you one of them? Was your transobturator tape placed incorrectly? If the manufacturer provided short videos and an instruction sheet, was that adequate training for your surgeon?

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Adverse Events Statistics Misleading – Transvaginal Mesh

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.”

Here are easy to follow instructions for reporting your own mesh injury. If you have new injuries? File a new report!

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RECIPE for Mesh Victims: Pasta Prima Vera

(A little comic relief after so much pain)

Pudendal Pasta Primavera Recipe

  • Prep time: Between 20 minutes and 5 hours
  • Cook time: 10 minutes
  • Yield: Serves 4

Ingredients

  • 2 regular strength Tylenol (you may substitute your choice of pain killer as needed)
  • 1/2 pound vermicelli pasta or spaghetti
  • 1 small bunch precut broccoli
  • 1 small zucchini, diced
  • 1/2 cup plus one unopened bag of frozen peas
  • 1/2 cup snow peas
  • 2 tsp. garlic powder
  • 1 8 ounce can seeded and diced tomatoes
  • 12 basil leaves, 3 tbsp. chopped or pre-packaged pesto
  • 4 Tbsp. butter
  • 1/4 cup chicken broth (use vegetable broth for vegetarian option)
  • 1/2 cup heavy cream
  • 1/2 cup grated parmesan cheese
  • Salt
  • 1 chilled bottle dry French white wine.

 

Method

1 Take pain killer. At the same time:

2 Fill a huge pot with water with water and turn on to “high.” Salt well. Set your strainer in the sink, turn on your timer to 13 minutes and go lay down with your feet up as high as you can tolerate.

  1. When alarm rings, throw pasta and set timer for 7 minutes. You must work quickly. Grab all other ingredients, open them and spread them on the counter.
  2. Put your hands on the edge of counter, legs back about 2 feet away and bend forward, breathe out a big loud sigh and stretch your pelvis so it doesn’t lock up on you while you’re standing. Hold this position for 30 seconds or until timer rings.
  3. At the 7-minute timer, throw broccoli in with the pasta. Boil for 1 minute. (You may try standing on one leg for 30 seconds and then the other if it helps.) Add the snow peas, and the 1./2 cup of frozen peas and boil for 30 more seconds.
  4. Quickly pour pasta and vegetables through the strainer and cool them under water. Leave them in the strainer, set the timer for 10 minutes and run back to lay down again, this time taking the bag of frozen peas with you. Apply to pelvis.
  5. When the timer rings, head back to the kitchen and throw the bag of peas back in the freezer.
  6. In a large sauté pan, heat the butter over medium-high heat. When the butter is hot, throw in the garlic powder, the diced tomatoes and sauté for 2 minutes, stirring often and shifting your weight from side to side.
  7. Pour in the chicken or vegetable broth and turn the heat to high to bring it to a boil. While waiting for it to boil, put one hand on top of another on the counter, lean forward and rest your forehead on the back of your hands, try to stretch your pelvis if it help. Add generous amounts of loud groans or tears as needed.
  8. Add the cream and stir just long enough to combine. Turn the heat down until the cream-chicken broth mixture is just simmering, not boiling.
  9. Add the Parmesan cheese and stir to combine. If the sauce seems too thick—it should be pretty thick, but not gloppy—add some more chicken broth, cream or water.
  10. As soon as the sauce is done or you are running into too much pain, transfer the pasta/vegie mess with tongs into the sauce and toss it around to combine. Add the basil now and salt if needed. Throw some black pepper over everything and grab a dish full to take back with you while you lay down again.
  11. After a half-hour rest, put remaining Pudendal Pasta Primavera in individual dishes and store in fridge. Eat for every meal until gone. If you hurt too much, eat it cold.

Note: You will want a dry white wine with this, ideally a chilled dry French white. Put the bottle against your pelvis for ten minutes at a time until pain relief is felt.

Leave dishes for someone else.

Tried, tested and enjoyed by ©Peggy Day

 

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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





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.

Burning Feet – Another Mesh Trouble

Some people express some surprise that even nurses have fallen for the doctor’s explanation that they should have a pelvic mesh implant, thinking that nurses would have done more diligent research. Nurses were trained to believe that all of the drugs and all of the devices they used had been carefully studied and approved. (Note: none of it was ever approved, it was “cleared.”) In most cases, only after being injured themselves, do they begin to do the careful research. One such nurse wrote this about peripheral neuropathy:

 “I have found that neuropathy is fairly common with mesh patients. Yes, the vagina is considered contaminated, so the surgery is considered ‘clean contaminated’ surgery. The real problem is that these implants should have never been implanted in a contaminated area.
“I kept telling my neurologist that my pelvis and feet and legs are connected. I can go into detail about why my theory we develop neuropathy makes sense to me.
“My theory is that all the nerves in the pelvis—part of the sacral nerves and L4-5 from the sciatic nerve (are involved). Because of severe inflammation, and foreign body response and mesh pulling on the nerves, we develop neuropathy. The gynecologist I am seeing here in Charlotte confirmed what I thought: that the pain we have from the pudendal nerve and the neuropathy in our feet and legs are related.
“The caudal epidurals stopped the pain and tingling, I can have another in August, I still feel some low level tinging and burning, but nothing like it was. The nurses told me they are treating other mesh patients with the same symptoms I have.
NervousSystem PERIPHERAL NEUROPATHY SHADING
Peripheral neuropathy is nerve damage to the nerves to your arms, hands, legs and feet—your periphery. The pain can be felt as tingling, burning, or feeling like you are wearing a stocking or glove. Some say ‘pins and needles,” others that their feet are on fire. More than a hundred types of peripheral neuropathy have been identified. Today’s blog is an overview—look for more about this soon from Mesh Troubles. Peripheral neuropathy (PN) after mesh surgery can be related to many causes.

Here are just some things that cause peripheral neuropathy:

•    Vitamin deficiencies
⁃    Alcoholism
•    Hormonal deficiencies
•    Autoimmune diseases
⁃    Diabetes mellitis
⁃    Lupus
⁃    Rheumatoid arthritis
⁃    Guillain-Barre syndrome
•    Compression above area with symptoms
•    Exposure to poisons
⁃    Heavy metals
⁃    Medications
•    Infections
⁃    Viral or bacterial infections
⁃    Lyme Disease
⁃    Shingles
⁃    Epstein-Barr
⁃    Hep C
⁃    HIV/AIDS
•    Inherited disorders
⁃    Charcot-Marie-Tooth disease
⁃    Amyloid polyneuropathy

There are three different kinds of nerves that can be affected by PN: sensory nerves that receive sensations such as heat, pain, or touch; motor nerves that control how you muscles move; and autonomic nerves that control functions such as blood pressure, heart rate, digestion and bladder function.
Peripheral neuropathy w foot drop copy
Symptoms:
◦    Gradual onset of numbness and tingling in your feet or hands which may move upward into your legs or arms
◦    Burning pain in affect areas
◦    Sharp, jabbing or electric-like pain
◦    Areas sensitive to touch
◦    Lack of coordination
◦    Muscle weakness or paralysis (motor nerves)
◦    Bowel or bladder problems (autonomic nerves)
Peripheral neuralgia may affect one nerve or more, one area or several different areas.
Treatments: First the good news. Correcting the underlying problem may heal PN. “Peripheral nerves have the ability to regenerate axons, as long as the nerve cell itself has not died, which may lead to functional recovery over time. Correcting an underlying condition often can result in the neuropathy resolving on its own as the nerves recover or regenerate.”

Self-care including maintaining optimal weight, exercise to reduce cramps and improve muscle strength and prevent muscle wasting, a healthy diet to correct vitamin deficiencies an minimize or eliminate sugar intake, limiting alcohol and exposure to toxins and medications, treatment of injuries, stopping smoking to improve circulation, meticulous care of your feet including visualizing them frequently can improve your symptoms.

Non-steroidal anti-inflammatory medications like ibuprofen can help milder cases and narcotic medications may be effective. There are some creams or ointments like Llidocaine or Capsaicin may help.

A “TENS unit” (transcutaneous electrical nerve stimulation)  can provide pain relief for some people. The therapy involves attaching electrodes to your skin at the site of your pain or near associated nerves and then administering a gentle electrical current. TENS has been shown in some studies to help diabetic peripheral neuropathy.

MESH IS FOR plastic_mesh_for_chicken_breeding
Sometimes hand or foot braces or orthopedic shoes help reduce pain or prevent injuries. Acupuncture, massage, and herbal medications help as well. Surgically, releasing a nerve can improve compressions injuries when a single nerve is involved.

Your physician may prescribe antidepressants but we recommend caution with those types of medication because one of the most common side-effects of antidepressants is neuropathy. Recently, anti-convulsant medications have been used to control the pain but  they are fraught with side-effects that are worse than the initial problems.

The very same process that was used to clear (mind you, they never say “approve”) plastic mesh to be irretrievably placed inside your body, is the one that cleared the drugs to be prescribed for nerve pain. The list of side-effects from these drugs (here is one example) is enough to make you run for the hills, yet they are routinely prescribed for peripheral neuropathy—some of them even cause PN! It makes no sense to me. Does it to you? You are the one who has to live with long-term effects for the rest of your life. Not the doctor you saw for fifteen minutes. What you you think about it? Isn’t your life is too valuable to risk taking a medication, like Paxil, that causes you to have suicidal thoughts in the middle of struggling with the devastating consequences of synthetic surgical 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.

Please, No Fibbing About Fibular Neuropathy

I have lower my head and confess that I used to be confused about the peroneal nerve: today’s mesh trouble. Okay, I thought it affected the perineum. You know what they say about making assumptions, right? Makes a gluteus maximus out of “u” and “me.” Okay, here’s the truth: the pudendal nerve serves the perineum and the peroneal nerve served the lower, outer leg and foot but, that’s not completely true any more. In 1998 scientists decided to change the name of the nerve to the fibular nerve and thought that should clear things up, right? Well, no. The scientists didn’t count on all the old doctors who were forgetting the new name and still calling it the peroneal nerve. For today’s blog, I’ll call it the fibular nerve.

Isn’t that what this blog is all about? Taking a close look at confusing and contradictory things that the medical profession says and sorting them out a bit so you can know what to do next?

Fibular nerve injury

Your common fibular nerve is a division of your sciatic nerve which travels near the outside of your biceps muscle to the outer side of your knee and then branches to the side of you lower leg before entering your toes. The nerve gives off branches along its way. The nerve can be injured at any level during surgery, or due to trauma or stretching.

In most cases, fibular nerve neuropathy, or fibular neuropathy, causes weakness in your ankle, trouble when you try to lift up your toes (dorsiflexion) as well as “foot drop.” Fibular nerve problems can create changes in sensation and movement to the outside surface of your foot and ankle as well as your outer three toes. One woman with fibular sensory changes said she felt like there was a blanket over the bottom of her leg all the time.

Fibular neuropathy is often misdiagnosed as sciatica, other nerve problems or systemic diseases. The most common injury causing fibular neuropathy is trauma, stretching, or compression at the top of your fibula (lower leg bone).
Diagnosing fibular nerve damage includes carefully listening to your description  of your symptoms, discussion of your past medical problems, and physical and neurological exams. Xray and MRI help narrow down the diagnosis but the most reliable diagnostic tool is the electromyogram because specific techniques can be used to determine how much recovery can be predicted for your particular injury.

Although there are many causes of Foot Drop, fibular nerve injury is the most frequent. Foot Drop is not itself a disease, but a symptom. Walking is a challenge with Foot Drop because you can’t control your ankle and you may develop a high-stepping gait in order to compensate. Some causes of Foot Drop are compression from a disc herniation, trauma to the sciatic nerve, bone fractures, crush-type injures, lacerations, among many others.

Symptoms:
•    Decreased sensation, numbness, or tingling in the top of your foot or the outer part of your upper or lower leg
•    Foot that drops (unable to hold your foot up)
•    “Slapping” gait (walking pattern in which each step makes a slapping noise)
•    Toes drag while walking
•    Walking problems
•    Weakness of the ankles or feet
MESH IS FOR bottlesleeve
Treatment is determined by the cause of the fibular neuropathy. It is is due to compression, relief of the compression may involve surgery. Strengthening exercises can help improve function, stretching to maintain your ability to move your ankle in all directions can limit contractures. Orthotics, including a lateral wedge shoe insert can help. More complex surgeries include neurolysis, nerve repair and nerve and tendon transfers.

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.

Sciatica After Pelvic Mesh Surgery – Was It Misdiagnosed?

A 2007 medical literature review took a look at the relationship between sciatica and the female pelvis. While pelvic mesh surgery was not implicated, pelvic mesh had not been in use very long when the study was conducted and more research is needed. However, surgical mesh bladder slings and posterior repair kits have been implanted, sometimes surgically shredded and later removed since 1998 and should be considered when sciatica follows pelvic or abdominal surgery. This is today’s mesh trouble.

Sciatic nerve pain, or sciatica, is most often due to a bulging or herniated disc in your spine pinching your sciatic nerve but gynecological surgery can also be the culprit. The 2007 study found cases in which the cause was gynecological or obstetrical and trauma due to pelvic surgery was misdiagnosed as disc disease in two cases. Unfortunately, in the 127 cases, it took an average of 3.8 years for the gynecological connection to be discovered (in one case, it took an astounding 15 years). The proper diagnosis was crucial because misdiagnosis sometimes lead to unnecessary, unsuccessful, debilitating and distressful spine surgeries. (Other causes of sciatica include spine trauma, osterarthritis, degenerative disc disease, pregnancy, endometriosis, and spinal tumors.)

"Jack-Knife" position
The sacral plexus, where sciatica originates, is immediately next to the posterior pelvic wall, the internal iliac blood vessels, the ureters, and the sigmoid colon (last loop of colon) and the terminal ilieal coils of the small intestine. When posterior mesh is used, there is greater risk of injury to those structures.

During abdominal surgery, nerve injury is usually related to poor patient positioning, a nerve being cut during the procedure, or excessive pressure on the nerve by the surgeon, particularly when he/she is trying to control bleeding from the hypogastric vessels. The use of the “jack-knife” position for vaginal surgery can cause nerve injury if the body is hyperextended or legs are rotated outward excessively.

Jack-Knife position.

Jack-Knife position.

“Vaginal operations have occasionally been complicated by sciatic neurophathy, possibly because of stretching of the sciatic nerve rather than direct pressure.” Other causes include badly placed intermuscular, or IM, injections (into the sciatic nerve), constriction by scar tissue and damage by the chemicals in the injection.

The sciatic nerve is the longest nerve in your body, branching out from your lower back, moving through both buttocks and down through your legs to your feet and is responsible for the movement and feelings in your legs and feet. If it becomes compressed, injured or inflamed, it can cause intense sciatic nerve pain anywhere along its path. No two cases are alike.

Sciatica due to pelvic issues is often diagnosed. The diagnosis is made by listening to your entire story, and conducting physical and neurological exams of your pelvis, back and legs. Special tests include and electromyogram (EMG) and nerve conduction velocity tests. Xray, CT or specialized MRI’s can identify abnormalities and specialized views of the pelvis are necessary.

MESH IS FOR belly dancing

Symptoms:
•    Unpleasant, painful, sensations from your back all the way down your leg to your foot, on one side or both.
•    Weakness, burning, numbness or tingling of the same area.

Treatment depends on the severity of your problems and any additional complications and includes physical therapy, chiropractic treatment, and exercises. You may also need to take tylenol (acetaminophen) or anti-inflammatory drugs. Some exercises that help include good posture, abdominal crunches, walking and swimming and careful attention to body mechanics while lifting.  Medications used to treat chronic nerve pain may also help.

Sciatica often goes away on its on after a period of rest and limited activities. Most people recover after 6 weeks but, for those who continue to suffer, this mesh trouble changes their life.

Saphenous Nerve Neuralgia – Lower Leg Sensational Problems

If you have sensation problems in your lower leg, saphenous nerve entrapment may be the culprit. Saphenous nerve entrapment is caused when pressure is placed on the saphenous nerve by the muscles in your thigh or the ligament-like tissue around it. It causes pain, numbness and loss of feeling in your lower leg.

Saphenous Nerve injury

When they want to numb up your leg for surgery (local anesthesia), the saphenous nerve is the one they block. It is the terminal cutaneous branch of your femoral nerve. A saphenous nerve is  most often injured during harvesting for Cornary Artery Bypass Graft (CABG) surgeries or during knee arthroscopy by pressure applied by the trochanter (a surgical instrument). It is strictly a sensory nerve and has no affect on your ability to move your leg or foot.

In order to diagnose Saphenous Nerve Entrapment, your doctor assesses the area where your change in sensation has occurred. One specific symptom is tenderness at the site where the entrapment is. Diagnosing it properly is important because it can mimic knee disorders and L4 spine rediculopathy (changes in sensation).

Symptoms:
•    Unpleasant, painful sensation or tenderness on inner side of your lower leg
•    Tingling, numbness, or burning on the inner (medial) side of the knee, inner leg, and occasionally the inner foot
•    Pain that increases with activities such as running, jumping, or long walks

Treatment: At first, the best treatment is resting from any activities that aggravate your symptoms. Intermittent ice and medications may help reduce pain and inflammation. Strengthening and stretching exercises may help reduce your pain. Physical therapy can provide exercises you can perform at home. If those measures are not helping, a corticosteroid injection may be used to help reduce the inflammation that is compressing the nerve. Surgery may be recommended for persistent problems, freeing the compressed nerve from the fascia that is placing pressure on it.

MESH IS NOT FOR BODIES 1

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.