Source: April Fools
I haven’t written to you in some time. Suffice it to say that the daily demands of life are sometimes overwhelming.
Anyway, I have missed you, and I’d like to take the liberty, this April Fool’s Day, to remind people about who the real FOOLS are. MESH IS NO JOKE – not the commercials, not the litigation, and certainly not the deeply personal injuries. You all know that, but it’s my hope that our community’s message still presses into new audiences, into the mainstream discussion among media, and around the proverbial water cooler at work. Any person with even the faintest bit of familiarity about the realities and mind-blowing chain of harm in the conception, manufacture, and implant of mesh knows the physical damage that mesh causes, and the destruction and havoc it wreaks upon the physical body.
But what about ALL THE REST. The SO MUCH MORE. The WHEN WILL IT STOP PART?
What about the reality that still exists when the commercial ends, after the trial or settlement, after all the surgeries than can be done have been done, and all the doctors who can be consulted, have been consulted? Does the general public really understand what’s left of us after all of that unspeakable harm?
I think not.
Injury by mesh is a physically and sexually violent assault. And, it’s an assault that reoccurs, for some women and men; it’s a daily assault, the experience of being reinjured time and again. As with any assault, the injury is not limited to a physical injury.
Mesh is a violent tormentor. It assaults the emotions, the intellect, the heart, the soul, and marches right on to damage families, friendships, jobs, hobbies, and pretty much anything of value in life. It’s damned ruthless and relentless.
Mesh is a cruel teacher. In our daily living and experiences with mesh, we learn who to trust, and who not to trust. Through a mesh-colored-lens, the true character of the people in our lives is revealed. Those we thought to be stalwarts of strength crumble; those we thought to be our closest comforters, suddenly vanish; those we thought were “in our corner” have turned against us; those whom we, ourselves, have helped through life’s harsh realities, are somehow unable or unwilling to reciprocate when the roles are reversed, and this time, we have drawn the short straw.
This experience is paradoxical and surreal.
We also discover those we thought watched us struggle in silence now appear as angels of help and hope. Those we thought to be meek are now our greatest advocates. Those we would not have met, but for this mesh, and the family of chance borne from our shared experience in its grips, have become our most trusted confidants. And in some ways, our family of chance has now become our family of choice.
Mesh is a crucible. By severe test and trial, unlikely heroes emerge, as do inconceivable villains. This improbable combination of elements and characters has become a white hot furnace, from which only the purest substance of the soul emerges. A soul, refined and laid bare by force, leaves only a remnant of its most fundamental quality.
From the crucible that is Mesh Hell can come all kinds of souls. Which words you choose to describe the phenomenon matters not. Anyway you slice it, you’ll find three
An Overwhelming Beauty. . . a soul who rises or has been risen above the hate somehow;
A Tepid Vapidity. . . a soul who’s lost its way in this life, or
A Destructive Odiom, a soul who can’t resist the siren call temporary relief that a vengeful mindset can provide. So shiny is the lure, we forget its hidden hook.
None of us had a choice as to how mesh harmed us and our loved ones, but we each do have the choice to emerge from this pile of ashes as a BEAUTY, though wounded; as VAPID AND NUMB; or seeking to repay evil for evil, falling so far that we, ourselves, have become MALICIOUS.
What will be left of us after the commercials and the trials are long forgotten? What will we have become? It is a difficult question to consider. It is an extremely painful question to consider at all.
We have every reason to be angry to our very core; to lash out in our pain. We have every reason to seek recompense, restitution and AN APOLOGY; every reason to expect those people to pay up, shut up, and go away. We have every rightful reason to hold disdain for these oppressors; the fat-cats who wouldn’t let their wives or daughters go near a mesh product, while they stand in court and so eloquently sing praises to the most holy mesh or stand in a surgery room and implant this ruinous tupperware into another human being, despite knowing there is even the slightest chance of harm. We and our loved ones are permanently injured. We have the right and the choice to be permanently bitter, furious, and set our minds on revenge for the rest of our lives. Who would blame us? Who could? No one.
There is a different option.
What if we chose – no what if we determined to set our thoughts and actions towards living our lives with joy despite the pain, chose to recognize the beautiful, chose to accept whatever grace, help, and mercy comes our way. What if we chose to be grateful that it isn’t worse; grateful to have had mesh removal; grateful even to have the knowledge that this implant is what has harmed our loved ones and our families? What if we chose to be beacons of hope, and a representation of the indomitable human spirit? What if we chose to joyfully seek occasion to meet others when at all possible, and share our stories to save someone else from harm? What if we became a generation of betrayed and harmed families who refuse to be forgotten; who refuse to go quietly into the night, who refuse to allow our voices to be silenced amidst the clanging noise of the lies, the money, the greed, the inhumane that surrounds us.
And what if we did all these things just to spite them, by reminding them that we are still here.
We are not going anywhere.
We wake up each morning with a clear conscience instead of a Mercedes.
What if our captors are the reason some of us will become great heroes and helpers; the voices that will stop the harm of future generations. What if our joy becomes the bane of their existence, while their baleful existence becomes the instrument of their own demise?
Who would be the fools then?
It really isn’t so unrealistic, unattainable, or impossible – not if we all believe, with an unshakeable knowing that we are here on this planet, not to be ravished, destroyed, and wasted; but to be uplifted and to exemplify the best of humanity, the best of human souls. What if we are the next GREATEST GENERATION, right now? The Greatest Generation didn’t know they would be remembered as such. They simply chose with their wills, with their hearts, and with their minds – they chose to do the right thing, and under tremendous adversity. We remember them for their qualities or fortitude, courage, bravery, persistence, sacrifice, frugality, self respect; love of country and family ; and a deep sense of pride in doing right. We cherish and revere them, and we wish there were more people like them. We mourn that so few remain. We mourn that our values are dying out with every death of one great soul, counted among America’s Greatest Generation.
What if we ARE the people like them. Mesh might be a new kind of evil to enter into the history of the world, but adversity and triumph over evil are as old as time itself.
“The Meaning of Christmas”
Brennan Manning, Reflections for Ragamuffins (1998)
In 1980, the day before Christmas, Richard Ballenger’s mother in Anderson, South Carolina, was busy wrapping packages and asked her young son to shine her shoes. Soon, with the proud smile that only a seven-year-old can muster, he presented the shoes for inspection. His mother was so pleased that she gave him a quarter.
On Christmas morning as she put on the shoes to go to church, she noticed a lump in one shoe. She took it off and found a quarter wrapped in paper. Written on the paper in a child’s scrawl were the words,
“I done it for love.”
When the final curtain falls, each of us will be the sum of our choices throughout life, the sum of the appointments we kept and the appointments we didn’t keep. The glory of the shipwrecked will be that they habitually failed to turn up for duty. In their defense they claim they were detained by a baby in swaddling clothes. When interrogated as to why they hung out at the stable, they answer,
“We done it for love.”
In their integrity the shipwrecked preserve the meaning of Christmas in its pristine purity–the birthday of the Savior and the eruption of the messianic era into history.
This Christmas, may you belong to their number.
“We love because he first loved us.” 1 John 4:19
“The Meaning of Christmas”
Reflections for Ragamuffins (1998), Page 359
As always, 100% of your purchase goes to support the Foundation and our Mission, Vision & Values to EDUCATE | ADVOCATE | and BUILD COMMUNITY for those injured by polypropylene mesh implant and their families.
The #TMWF coffee mug is a wonderful gift for your favorite mesh-injured friend or loved one, and at just $12, it’s an affordable way to give a truly meaningful gift – one of warmth, compassion, and friendship.
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Dr. Shlomo Raz, known wide and far by our Mesh Warrior community as the preeminent surgeon for full transvaginal mesh excision, debates a fellow urogynecological surgeon at the 2015 American Urological Association Annual Meeting, held in New Orleans in May of this year.
Below is the video of the debate.
What do YOU think about the merits of each position?
*WARNING – There is graphic medical content including live-action film of genitalia and surgical interventions.
A short update today, Thanksgiving Day.
Most of us will think about ways to give thanks today; after all, that is what Thanksgiving Day is all about.
But. . . . consider how you RECEIVE thanks.
When someone tells you:
“You look great!”
“I’m so happy you’re here!”
“The turkey is amazing!”
“Your house is beautiful!”
“Thank you for hosting Thanksgiving!”
“You make THE BEST pies!”
How do you respond? Do you RECEIVE a compliment well?
If you don’t; practice today. I once heard it said that,
“You know you’ve become a woman when you’ve learned to accept a compliment.”
NO IFs, ANDs or BUTs!
No justifications. . .
“Well, I just threw things together,” or “The turkey didn’t turn out like I’d planned,” or “The house is such a mess – we need to redo the bathroom” or “FILL IN THE BLANK.”
RECEIVING THANKS is a part of gratitude and being thankful.
Own your awesomeness today! When someone says, “You make the best pies,” simply say “Thank you.” Even better, share your recipe.
Thanking someone or being thankful for something is only half the equation. Show anyone who compliments you, your “thanksgiving” by accepting the compliment and taking it to heart with a smile. Your loved ones will feel gratitude because you acknowledged their effort, and you will know that you are cherished and people are grateful for you.
Happy Thanksgiving to you all!
This past week/weekend, amidst the worldwide panic and sorrow over the terrorist attacks in Paris, I attended the National Center for Health Research’s second Patient Advocacy Workshop in Washington, D.C. It was strange to be there under such uncertain circumstances. I couldn’t help but worry about if one of our nation’s capitol cities, even D.C., could be next. Thankfully, that was not the case, and all of us returned to our homes safely, despite concerns at the three D.C. airports: Several People Removed from Spirit Airlines on flight departing BWI.
I felt at home, as I was surrounded by 30 or so patient advocates; individuals just like me, who advocate for a loved one, or by their own injuries, effort daily to raise the public’s awareness about the breadth and depth of medical harm. Many of these folks touched my heart. Like all of us, they each struggle to comprehend how so much harm has befallen so many and has come from the very institutions meant to promote good health and protect and preserve health as stakeholders in the health of our nation.
If you are mesh injured, and you don’t think this post is for you, keep reading.
Patients and advocates came from all corners of the nation for this conference: Hawaii, Pennsylvania, California to Tennessee; and everywhere in between, including Texas! Each attendee was invited for differing healthcare concerns, but we were all there for the same purpose: To unite as advocates who are committed to bringing real-world patient voices to industry and government.
After breakfast Friday morning, we began with a test to gauge our current knowledge base and understanding of the FDA and its regulatory practices. We took a follow-up test at the end of the program to gauge what we learned from our training sessions. I don’t have my results yet, but I promise to share them once I do!
Our training began in earnest as we learned the ins-and-outs of the FDA and its regulatory policies from our host and the founder of the National Center for Health Research and the Cancer Prevention and Treatment Fund, Diana Zuckerman, Ph.D. Dr. Zuckerman has a lengthy career as a scientist and researcher, as a faculty member at Vassar and Yale, and as a researcher at Harvard. Her work on Capitol Hill has ranged from Congressional staffer to AAAS Congressional Science Fellow and former senior policy advisor to First Lady Hillary Rodham Clinton. She has spoken dozens of times before Congress, federal agencies, state legislative committees, and even the Canadian Parliament! Formally trained in epidemiology and public health at the Yale College of Medicine, her work at NCHR now focuses on creating a stronger FDA. She serves on the federal Medicare Coverage Advisory Committee and on the board of directors at The Reagan-Udall Foundation and the Alliance for a Stronger FDA.
We then took time to introduce ourselves, our areas of interest, and what we hoped to gain from our attendance and training. Those moments were some of my favorites. That time gave me hope, because there are so many individuals who have made great strides in their advocacy. It reminded me that the possibilities for our mesh-injured community are endless. It renewed my hope in our shared cause. As is most often the case, it is the individual human being who has the capacity to make the most significant changes for good. I am reminded of the famed quote by author, seeker, academic, anthropologist and all-around troublemaker, Margaret Mead, who said,
“Never believe that a few caring people can’t change the world, for indeed, that’s all who ever have.”
I met more than a few caring people at the workshop.
I met a man who suffers from Ataxia; a congenital, degenerative neurological disorder that progressively affects coordination, speech, and swallowing. It must have required enormous effort each time he spoke, but I am forever changed by the confidence with which he uttered each word. Unafraid to ask for help, as he should be, he introduced himself and offered, “If you don’t understand what I say; ask me to repeat it.” What a powerful message, one from which we all can learn. Find out more about Ataxia from The National Ataxia Foundation, established in 1957, and dedicated to improving the lives of persons with Ataxia through support, education and research.
I met parents who have lost their young adult daughters to the often downplayed, lethal risks associated with hormone-based contraceptives. These parents have taken action; not because someone told them to, but because they want to honor their daughters’ legacies and raise awareness, with the hope that they will prevent others from experiencing the devastation of losing a child. Their heartbreak was so palpable that it was like another advocate in the room. Many people, from all walks of life, say that there is nothing in life so painful as the loss of one’s child.
Richard and Dianne Ammons honor the life and loss of their daughter, Annie, to YAZ, a drospirenone, hormonal contraceptive. They raise awareness through their Letters To Annie website. Other advocates Joe (www.birthcontrolsafety.org) and Dru (www.birthcontrolwisdom.com) honor their daughters’ legacies and raise awareness about deadly blood clots associated with the Nuva Ring hormonal contraceptive device.
I met a charter member of Washington Advocates for Patient Safety, who though injured by a metal-on-metal hip implant herself, still advocates for others, even as she continues to suffer daily. In fact, The Center for Medicare and Medicaid Services, just yesterday, announced their Comprehensive Care for Joint Replacement Model (CJR), saying,
“Hip and knee replacements are the most common inpatient surgery for Medicare beneficiaries and can require lengthy recovery and rehabilitation periods. In 2014, there were more than 400,000 procedures, costing more than $7 billion for the hospitalizations alone.”
I met a man, now disabled for life, who was implanted with a spinal medical device used off-label by his surgeon. With access to the best care in the world and a powerful family to boot, not even he could escape the long arm of medical harm. His story speaks to how overwhelming the issue of medical device harm has become. It does not discriminate.
I met a U.S. veteran from Austin, TX who was exposed to Agent Orange during his service to our country and has suffered and survived prostate cancer as a result. He now facilitates a Prostate Cancer Support Group, a group that I imagine my husband’s grandfather, a fighter pilot in the Vietnam and Korean Wars, would have benefited from greatly.
I met mothers whose children suffer from rare diseases, and for which it is so difficult to raise awareness (not so different from mesh injury in that regard). I met many women who suffer from rare heart disease, yet are stigmatized. We agreed that no one deserves to be judged by any health condition, especially the number one killer in the U.S. for both men and women: heart disease.
I met a woman from Essure Problems who was involved with the recent FDA public hearing addressing Bayer HealthCare’s Essure System for permanent female sterilization and the adverse reactions associated with the permanent contraceptive device. Somewhat shy and reserved, it was hard to imagine that she recently spoke to the FDA. I point out this fact, because it is proof-positive that anyone can be an agent of change. All that is necessary to become an influential patient advocate is that you care deeply about others, and that you’re willing to push through any fear that could hold you back or keep you silent.
Two representatives from the FDA gave a brief presentation to explain how patient advocates can become involved in patient-centered policy at the FDA.
We also heard from PCORI, the Patient Centered Outcomes Research Institute and how, in just three short years, the newly-formed organization has funded many research projects with the aim of measuring outcomes which relate to the patient’s perspective and well being. We learned that, far too often, research in healthcare is designed to test and measure factors that may impact the patient, but may not always be designed to assess the benefit of any given outcome to the quality or quantity of patients’ lives.
Susan Molchan, MD, a decorated physician and scientist provided an eye-opening perspective. Having worked in private practice, as a staff psychiatrist for the National Institute of Mental Health (NIMH), and as a medical officer at the FDA, she is a walking library of experiences! She has returned to clinical work and writing in her areas of interest: healthy aging, health literacy, and conflicts of interest in medicine. She now serves as attending psychiatrist at the Walter Reed National Military Medical Center in Washington, D.C. She spoke to us in her capacity as a member of the board of directors for the National Physician’s Alliance, an organization which champions “The Unbranded Doctor,” and the core values of the medical profession that many would say have been lost: Service, Integrity, and Advocacy. I’m glad to know the NPA exists, for surely there are many physicians who care deeply about the core values of their chosen profession and realize that so much trust between patients and physicians has been broken. It’s a great resource for us, as patients and advocates, too.
We heard inspiring talks by longtime patient advocates like Desirée Walker, who having survived breast cancer twice, refers to herself as a “Cancer Victor.” Desirée works with the U.S. DOD-funded breast cancer research program and has made such an impact for good towards the search for a cure.
Tim Horn, HIV Project Director at the Treatment Action Group, reminded us that the long journies of HIV/AIDS patients and advocates, who came before us, can serve as an example for all of us. Though the road is long, significant change can be brought about by our long-term commitment and the continued courage to speak out, even through setbacks and progress that seems to come far too slowly for those who are suffering and dying.
The lives of these patients and advocates and the stories they tell are just like ours.
We are most certainly not alone in our fight against the epidemic of preventable medical harm and the diseases, common to all, which require the FDA to get involved in service of America’s public health. We even share the hurt that all patients suffer under the guidance of a public health system that can be much too bureaucratic to mobilize in the face of infectious disease. We’re experiencing that very problem now, as the irresponsible use and administration of antibiotics continues to hasten antibiotic resistance.
In sharing these insights, my hope is that no person in our community would feel abandoned or alone. We can connect to others through our shared suffering, but once connected, we can live our lives alongside one another to create a “new normal” which can draw us out of the isolation and loneliness of chronic illness. Suffering is suffering. We all experience the common feelings of anger, loss, regret, sorrow. . . and hope. As Desirée says,
“He who has health has hope. And he who has hope has everything.”
Though many of us have lost a great deal of our health, and we grieve that loss; we can also choose hope, for we still have health.
Thank you to the staff members at NCHR and PCORI for allowing us to learn from one another and together, as individuals working in concert, help us to gather our voices so that each of us may be heard louder still.
And for those of you who actually read this far, here’s a funny for you. If it’s one thing I think we all agree on, it’s that humor is often the best medicine, and sometimes the only medicine for our broken bodies and hearts.
~ For my mother, whom I love with audacious action. ~
Below are two more physicians who are participating in the prospective cohort study, ordered by the FDA:
If you live in or around Sioux Falls, SD or Allentown, PA, please be aware of these recruiting physicians, and please share this post with friends and family members who live in these areas.
Sioux Falls, South Dakota, United States, 57104
Contact: Jessica Howard/605-328-1389
Principal Investigator: Kevin Benson, MD, MS
Contact: Marcie Taff, RN/610-435-9575
Principal Investigator: Vincent Lucente, MD, MBA
It is no surprise that Dr. Lucente is recruiting for the Coloplast Restorelle study that would implant new women with a Coloplast product. The doctor touts his role as a “Proctor” for Coloplast. A proctor is usually a doctor, paid by a manufacturer, (in this case, Coloplast) to tour the U.S. or other parts of the world to teach other physicians how to use the manufacturer’s product(s). In this case, Dr. Lucente has been touring Australia, teaching physicians how to use Coloplast’s “Altis Single Incision Sling” for SUI. Many of Coloplast’s products under litigation, for SUI and POP, are still sold.
See below for a video describing the placement of the “Altis” device.
The important point here is that many doctors (and very obviously Dr. Lucente) have an incentive to recruit patients for these studies, because THESE DOCTORS ARE PAID BY THE MANUFACTURER TO DO SO. To me, that represents a clear conflict of interest for any FDA-ordered follow-up study (522 study) to render unbiased science.
Coloplast “Altis” Procedure Animation
I wouldn’t necessarily say I’m ending this post on a high note, but I am ending it on a note. . . from the great Billy Joel and his famous song, “Allentown.”
Dear Allentown, PA:
Don’t let the manufacturers of ANYTHING “take all the coal from the ground” again or return under a new name to take your mothers, grandfathers and fathers who “met at the USO” and fought and survived World War II at home and abroad. Mesh manufacturers, too, will “crawl away” leaving a generation of your families demolished by polypropylene mesh.
I wouldn’t say it if I hadn’t seen it myself.
Generations of families are being wiped out by an enemy of a different name.
The rest of the country thinks of your community as the great, sturdy, American, Allentown.
Stand up to mesh in your community!
“Allentown” Lyrics/Billy Joel (1982)
Well, we’re living here in Allentown
And they’re closing all the factories down
Out in Bethlehem they’re killing time
Filling out forms
Standing in line
Well, our fathers fought the second World War
Spent their weekends on the Jersey shore
Met our mothers in the USO
Asked them to dance
Danced with them slow
And we’re living here in Allentown
But the restlessness was handed down
And it’s getting very hard to stay
Well we’re waiting here in Allentown
For the Pennsylvania we never found
For the promises our teachers gave
If we worked hard
If we behaved
So the graduations hang on the wall
But they never really helped us at all
No they never taught us what was real
Iron and coke
And we’re waiting here in Allentown
But they’ve taken all the coal from the ground
And the union people crawled away
Every child had a pretty good shot
To get at least as far as their old man got
But something happened on the way to that place
They threw an American flag in our face
Well, I’m living here in Allentown
And it’s hard to keep a good man down
But I won’t be getting up today
And it’s getting very hard to stay
And we’re living here in Allentown
Here’s your “Doctor a Day.”
READ ON FOR “A Dose of Hope!”
If you live in or around the Cincinnati area, please be aware that this doctor is recruiting new patients for a prospective cohort study which would include the implant of NEW WOMEN with Coloplast’s Restorelle Direct Fix for repair of POP. Here is the study: Restorelle® Mesh Versus Native Tissue Repair for Prolapse
Please share with any friends and/or family members who live in the area, and please take action, yourself, by calling or emailing the doctor to share with him why you think this study is dangerous, or whatever your personal thoughts may be. We may never know who we’ve helped with a single phone call or email.
Good Samaritan Hospital
Contact: Vivian Ghodsi, RN, CCRC 513-463-4308 firstname.lastname@example.org
Cincinnati, Ohio, United States, 45220
Principal Investigator: Steven Kleeman, MD, FACOG
A Dose of Hope
I am extraordinarily grateful and humbled to have been accepted and awarded a scholarship to participate in an important patient advocacy workshop next week in Washington, D.C.!
Diana Zuckerman, Ph.D., President of the National Center for Health Research and the Cancer Prevention and Treatment Fund is the workshop’s organizer. Not only does Ms. Zuckerman have a lengthy and impressive career in advocating for patient health and safety; she is also very knowledgeable about mesh and has been speaking out about its risks more than a decade! In fact, she participated in a briefing on Capitol Hill with Dr. Shlomo Raz/UCLA a few years ago.
I am BEYOND GRATEFUL for the scholarship and for this opportunity to learn from, not only Diana, but also her colleagues and the other, 30-or-so, attendees.
The workshop is a two-day learning seminar, and I’m preparing this weekend so I come with a fresh mind, ready to listen and learn. If you have any questions you’d like me to bring up at the workshop, please email me at: themeshwarrior[at]gmail[dot]com or comment on this post with your question.
Helping, Hoping for Healing . . .
Aaron/The Mesh Warrior
Here is your “Doctor A Day,” Costas Apostolis, MD at Akron General. You know what to do!
Akron Urogynecology Associates
Akron, Ohio, United States, 44333
Contact: Connie Cottrell 330-344-7681
Principal Investigator: Costas Apostolis, MD
Science with Hope
Many of you may have seen the recent video posted by Dr. Shlomo Raz and his team at UCLA. Associate Professor, Division of Pelvic Medicine and Reconstructive Surgery, Department of Urology, Ja-Hong Kim, MD, and a fellow of Dr. Raz, hosts a 20-minute video presentation titled, “What You Need to Know About Vaginal Mesh for Female Pelvic Surgery.” Dr. Kim opens her talk by saying, she will provide a “clear, concise overview of mesh.” Finally, a well-respected surgeon is putting transvaginal mesh in plain English. This video will surely provide a much better education for women who are considering mesh as an option for repair of POP or SUI. Please watch the video below, and then read the rest of my post.
- 1:25 – Dr. Kim defines Stress Urinary Incontinence (SUI) as a loss of urine during physical activity due to weaknesses of the pelvic floor. Dr. Kim notes that a woman’s lifetime risk for developing SUI is 20% – 40%. A 20% variability represents several standard deviations. I believe it is the most conservative approach to cite the highest level of known risk in treating SUI with mesh: 40% LIFETIME RISK.
- 1:42 – Dr. Kim defines Pelvic Organ Prolapse (POP) as a vaginal bulge of pelvic organs resulting from weaknesses of the pelvic floor and cites that a woman’s a lifetime risk for POP is 30% – 50%. Again, with a 20% variability, I believe the most conservative approach, when contemplating repair with mesh, would be to use the highest incidence of lifetime risk: 50% LIFETIME RISK.
The Coloplast Restorelle® Mesh Versus Native Tissue Repair for Prolapse study for which I’ve been posting “A Doctor A Day,” has INCLUSION and EXCLUSION criteria.
I’m concerned about two of the INCLUSION criterion, specifically:
- Subject has pelvic organ prolapse with leading edge at or beyond the hymen. At or beyond the hymen is defined as POP-Q scores of Ba ≥0 and C≥ -1/2 tvl or Bp ≥0 and C≥ -1/2 tvl
- Subject reports a bothersome bulge they can see or feel per PFDI-20 question 3, response of 2 or higher (i.e. responses of “somewhat”, “moderately” or “quite a bit”)
These two criterion for INCLUSION are part of a longer list of criteria that defines a “good candidate” for the study. A woman who has early stage prolapse (Ba ≥0 and C≥ -1/2 tvl or Bp ≥0 and C≥ -1/2 tvl) and/or answers questions about how “bothersome” a “bulge” is with the answer of “somewhat” or “moderately” bothersome is considered a “good candidate” for the study.
In my many discussions with urogynecologists, some of them have been shocked, and even quite upset, that a mesh implant was used for a woman in early or moderate stage prolapse. These physicians said,
“Treatment of POP with surgical intervention and mesh implant should be a TREATMENT OF LAST RESORT.”
According to the University of Virginia, there are stages of POP, 0-4.
- Stage 0 means that there is no prolapse. The pelvic organs like the vagina, bladder and rectum are perfectly supported by the ligaments in the pelvis.
- Stage 1 means that there is virtually no prolapse. The pelvic organs are very well-supported by the ligaments in the pelvis.
- Stage 2 prolapse means that the pelvic organs are not as well supported by the ligaments and have begun to fall down. In Stage 2 prolapse, the organs are still inside the vagina.
- Stage 3 prolapse means the pelvic organs are beginning to bulge to or beyond the opening of the vagina.
- Stage 4 prolapse means the pelvic organs are completely outside of the vagina.
Do you know which stage of prolapse you have/had at the time of mesh implant?
Do you think it is ethical for a study to recruit NEW patients who are in early-stage prolapse?
If you could talk to a woman who is considering participation in this study, what would you tell her?
NOTE: MY OBSERVATIONS SHOULD NOT BE TAKEN AS MEDICAL ADVICE AND SHOULD NOT BE A REPLACEMENT FOR SEEKING THE MEDICAL OPINION OF YOUR DOCTOR. THIS INFORMATION IS PROVIDED AS AN EDUCATIONAL TOOL ONLY. MY COMMENTARY IS MY OWN OPINION, BASED ON MY OWN RESEARCH AND MY OWN EXPERIENCE. THE QUESTIONS I RAISE ARE MEANT TO BETTER EDUCATE YOU, SO THAT YOU MIGHT HAVE A MORE PRODUCTIVE CONVERSATION WITH YOUR MEDICAL CARE TEAMS.