Studies Before & After Mesh
My daughter found a link last night about studies that have been done about mesh and after removal and I began reading them this morning. Yes I AM biased about the use of mesh in pelvic surgeries done on women. And yes I have several valid reasons. First I have taken four years of my life to listen to many, many women as they go through their own mesh journey. I did not study them at all. In fact for a long time I did not realize the kind of service I was doing for women, because I was trying to learn the best way to get out of my own mesh hell. I did not follow them for a few months. I still stay in touch with women if they choose, whose journeys began many years before mine, but not one doctor put two and two together to give them a chance at living again. They were simply told it was something else and NEVER the mesh in their bodies. They are not part of any long term study because there was none done on women after mesh was placed into their bodies. When things got so bad, those who could, searched for answers through the Internet and some found me. Those who were too weak, were left to die. So YES I am biased. These women are people not just studies.
At the bottom of this blog I will give you the link where it stated about these studies. But I took each abstract and found the complete result of each study to share with you and I am going to tell you MY opinion as a mesh injured woman and one who knows hundreds of other women who live with the results of mesh injuries.
At the top of this report sent out to the media to be picked up by anyone who is looking for a story, this was the first statement.
STUDIES EXAMINE IMPACT OF SOCIAL MEDIA, TELEVISION ON LITERACY AND PERCEPTION OF VAGINAL MESH AND REMOVAL SURGERY
Panel discusses patient perception and experience of changing landscape in surgical use of vaginal mesh
Orlando, FL, May 19, 2014 — Four studies evaluating patients’ knowledge and perception of vaginal mesh prior to surgery, as well as after mesh removal, will be presented to the media during a special press conference at the 109th Annual Scientific Meeting of the American Urological Association (AUA) Monday, May 19, at 9:00 a.m. ET, in the Orange County Convention Center, Orlando, FL. The session will be moderated by Tomas Griebling, MD, MPH, professor and vice-chair of the Department of Urology and faculty associate in the Landon Center on Aging at the University of Kansas.
Prospective Evaluation of Patients’ Knowledge and Perceptions of Mesh(#PD33-08): Although the U.S. Food and Drug Administration (FDA) released an updated safety communication in 2011 regarding the use of transvaginal mesh for pelvic organ prolapse (POP) and stress urinary incontinence (SUI), many patients still appear to have misconceptions regarding the use of synthetic mesh in female reconstructive surgery, according to a new study by researchers from the Glickman Urologic and Kidney Institute, Cleveland Clinic, Cleveland, OH. Researchers administered a 25-question prospective survey between March 2013 and November 2013 to new female patients presenting to a single academic institution specialty clinic for either POP or SUI. Study results showed the majority of new patients (70 percent) obtained most of their information about mesh from television. Although 61 percent stated they were aware of the FDA safety communication, 65 percent said they were unsure if the mesh used for SUI was different from the mesh used for POP. Despite their awareness of the FDA safety communication, 50 percent believed there was a mesh recall. Researchers conclude patients do not fully understand the uses of synthetic mesh; therefore physicians should educate patients about synthetic mesh and resolve any misconceptions concerning the use of mesh in female urologic surgery when providing counsel on treatment options for POP or SUI.
I want you to pay close attention to a few things when reading each report, so I am going to point them out using lavender writing. Each report has introductions and objectives.
1st up. This study was one done by UCLA and a packet was sent out to all of us who went there for mesh removal. Only 32% of women filled them out and sent them back and I can tell these doctors why. Mesh injured women have difficulty with medical PTSD brought on by the trauma of having mesh inserted and the consequences of what it has done to their lives. Then living with those complications and the difficulties of making decisions of getting their mesh removed. They live in FEAR of making the wrong decision and they worry that the outcome will be worse, than the way they are living before it is removed. I know women who can’t get out of bed and they are on so many narcotics to try to ease the pain. Even with all that, they are afraid they will die from having it removed. Or worse yet live in even more agony if something goes wrong. Their fears are truly founded because I know many women who went to one doctor only to find themselves worse off and they still have to face travelling far from home to have the rest removed. It truly is daunting and nothing I say or do can help them through this struggle.
Not only this but most women have joined a lawsuit. You don’t just sign up with a law firm and then sit back and concentrate on the state of your health. There is piles of paperwork to fill out, bills you have to go through to face all the money it has cost to go through your trauma. Many women can’t face it and I know some that never did it and as a result the lawyer dropped them. You have to be able to concentrate when you do this but many women are on so many pain narcotics just to get up out of bed and their brain fog is so bad they can’t answer questions or remember anything.
Even after mesh removal they have to go through the depression if their pain is very bad. They have family all around them that wonders why they aren’t getting better and that makes them more depressed. Plus they also wonder why mesh removal didn’t fix them. I have been through all this so I understand how they feel. But I do know the first few months after removal is the hardest of all. It takes time to see the results and it is harder when families don’t understand.
So to receive a package in the mail that they have to fill out and relive all their experiences is extremely difficult to deal with and many can’t deal with it. So it did not surprise me to see that only 32% of women filled out their study and sent it back. It is of no fault of the women who are injured by mesh. It is how their lives turned out because of their mesh injuries.
Introductions and Objectives
Despite the growing number of vaginal mesh removal surgeries, little is known about patient quality of life in terms of pain, incontinence, and sexual function after mesh has been removed. We present the short and long terms results of patient satisfaction after mesh removal surgery in our patient population.
A retrospective review was conducted of all vaginal mesh removal procedures performed at the Division of Pelvic Medicine and Reconstructive surgery at UCLA between 2006 and 2012. Vaginal prolapse, sling, and sacrocolpopexy mesh removal were included. Six hundred and sixty-two patients were identified and sent surveys pertaining to their quality of life. The questionnaire included the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12), Incontinence Symptom Score (ISS-8), a modified Stanford comparative pain scale, and a modified International Prostate Symptom Score (I-PSS). Patients were asked where their pain was located on the body and whether they had any systemic symptoms related to mesh. Surveys were collected and reviewed.
Two hundred and fourteen surveys were collected with a mean follow up rate of 32%. The mean patient age was 65 years old (range 35-92). Mean follow up time since surgery was 39 months (range 5 – 95 months). In terms of improvement after surgery, 55% of patients stated that they were “very much better” or “much better”. A further 22% stated that they were “a little better” while 17% percent stated that they were “much worse” or “very much worse” after the surgery. On the Stanford comparative pain scale 66% of patients rated their pain as mild (score 0-3) while 33% rated their pain as moderate to severe. 30% of patients stated that they had no pain. Many patients continued to have incontinence after the procedure although this was mostly irritative: 64% complained of moderate to great bother due to frequency and 59% complained of moderate to great bother due to urgency. Twenty eight percent of patients complained of stress urinary incontinence at least once a day. In terms of sexual function, 49% of women responding complained of dyspareunia. Twenty seven percent stated that they were no longer sexually active while 20% stated that fear of incontinence usually or always restricted their sexual activity.
In this retrospective questionnaire of mesh removal patients, 77% of our patients were much better or improved while 22% were much worse. Our study was limited by a low 32% response rate. The use of vaginal mesh has the potential to cause permanent and disabling pelvic pain, urinary incontinence, and sexual dysfunction despite subsequent mesh removal.
Authors Kang, Diana (Los Angeles , CA); Hartshorn, Tamara; Choi, Judy; Nakamura, Leah; Rodriguez, Larissa; Kim, Ja-Hong; Raz, Shlomo
I want these doctors to understand why so many women didn’t come back with their surveys. But I also want them to not give up and keep conducting these surveys over a period of years. This is why. If you are three to six months from mesh removal you may think you’ll never get better at all but you don’t realize how slow it is for the body to heal from the hell of mesh complications. It sometimes takes years and a lot of diligence. I want them to know that if a woman works at getting better over a period of two years, eventually her life will improve somewhat. Not the perfect life she once had but she will be able to live again in a new way. I also want them to know that I know women who were on huge amounts of narcotic drugs but eventually they got off them. It was not easy. I just had a conversation with a women yesterday who went out to UCLA and she did get off them over time and is beginning to live once again. And it is all because of the doctors at UCLA. So don’t get frustrated by the results of your surveys. I see the results of their lives after mesh removal and I thank you all for helping so many women.
Now for the next study #2
This one came from doctors in Dallas, Texas and Texas is the state I live in. When I was first injured by mesh I sought answers in my own State. There was almost nothing on the Internet at that time, which is why I began this blog. Because of writing about my own complications, women came forward to tell me that they did not fare well from mesh removals here in Texas. They reported so many partial removals to me in their local area and they wound up seeking full mesh removal out at UCLA. It is because of these women that I continue doing what I do and pay it forward through this blog. I will also say that who any woman chooses to remove her mesh is of FREE WILL and I am not going to make that decision for anyone. I chose to travel far from home even though it was a very difficult decision to make. I chose it, no one else. That is why women should read, learn and do the best they can with whatever funding they have. I will not put women down for their choices because only they know why they choose who does the job. I don’t.
I can tell you that a minimum 6 month follow up is absolutely ridiculous. I know women who went to doctors in this State and many believed they were better at first. BUT…then they realized it was an illusion and in fact they too traveled out to UCLA. I suggest these doctors continuing evaluating their patients over many years and when they do, they need to LISTEN to them. Many doctors listen to themselves talking and not to their patients. I can also tell these doctors that when women complain to them, they are sent to pain management and the women then make a decision to do what they can to help themselves, without the help of their doctors. I can tell these doctors that 81% pain free status is far too high and they are impressing themselves, not the women who are left in pain. They should go back to the drawing board and learn from the women themselves. IF the women will want to go back to them at all. Frankly most women won’t go back if they are not listened to by their doctors because it is a waste of money and time. So here you can read the results of that study.
Introductions and Objectives
Because there is reluctance to operate for pain, we evaluated mid-term outcomes of vaginal mesh (M) or synthetic suburethral tape (T) removed for pain as the only indication.
Following IRB approval, a prospective database on non-neurogenic women operated for M or T removal, with the focus on pain as the only and single reason for removal, and a minimum 6-month follow-up, was reviewed. Primary outcome was pain level assessed by Visual Analog Scale (VAS) (0-10) at baseline and at each subsequent visit as documented in the electronic medical record upon arrival, with the last visit VAS score used for this analysis. Parameters evaluated included demographics, mean time to presentation, and type of M or T inserted.
From 2005-2013, 123 patients underwent surgical removal (69 M, 54 T) with pain as the only indication (Table 1). Mean follow up was 35 month for the T group (6-59) and 22 month for the M group (6-47). VAS dropped from mean pre-operative level of 7.9 to 0.9 after surgery (p=0.0014) in the M group, and from 5.3 to 1.5 after surgery (p=0.00074) in the T group. Impressively, pain-free status (VAS score=0) was achieved in 81% of T and 67% of M. In the pain persistent group, there was no difference in mean time to presentation since the placement surgery, with 36.2 month (31-42) for the T group and 37.5 month (32-39) for the M group (p=0.62). No statistically significant difference was found between T and M groups.(Table 1)
When pain is the sole indication for T or M removal, a significant reduction in pain score can be durably expected after removal in the majority of patients at mid-term follow-up.
Authors: Hou, Jack (Dallas, TX); Alhalabi, Feras; Zimmern, Philippe
I love how these studies decide how ‘many patients appear to have misconceptions’. I also want you to note that the study itself is biased. The study was done by their quote on ‘typical patient is 60 years of age, 87% Caucasian, 62% married, with at least a high schools education’. So let me explain how it is in the mesh injured world. I receive messages from women from 21 years of age, young mothers who cannot take care of their children because of their mesh injuries. I receive many messages of women who find themselves divorced because they can no longer have sex with their husband’s. No income. Going through the long process to collect disability because no one believes mesh injured women. After all the outside of the body looks normal. But I can tell these folks who do these studies that the insides of the bodies are so badly damaged they may never have sex again. Many women will remain alone for the REST of their lives. I listen to women of ALL races and all educations and it may surprise them to know most women are well educated and lost their careers due to mesh complications.
I can also tell these people that the reason the women find themselves in the mess they are in, is because when they go to doctors since the FDA report, their doctors tell them overwhelmingly that they don’t use the mesh that was cited in that report. In fact according to most doctors, there are new and improved variety meshes that will fix their problems and they can resume their everyday lives. NOT SO I am afraid because I see the results of those new types of mesh. Their doctors don’t because they dismiss their complaints and send them off to ‘pain management or physical therapy’.
The reason why they don’t listen is because when a woman complains of pain, she is told it is all in her head, or they are treated as lepers never to see or touch again. So what the FDA has stated about doctors should inform women, is a load of bunk! They are not and they will not do anything voluntarily because using mesh is their living.
And no, women are not aware of the types of prolapse or incontinence repairs! Isn’t that the job of the doctors when the women go to them when they have a problem to explain what these are and how they can be fixed? Do women have to go to medical school so they can diagnose themselves? Apparently these days they do. So why bother with this part of a study? Doctors go to school for this, not the women who go to them.
Introductions and Objectives
In 2011, the U.S. Food and Drug Administration (FDA) released an updated safety communication regarding the use of transvaginal mesh for pelvic organ prolapse (POP) and stress urinary incontinence (SUI). Many patients appear to have misconceptions regarding the use of synthetic mesh. The objective of this study was to evaluate patients’ understanding regarding the use of mesh in female reconstructive surgery.
A 25 question based survey was prospectively administered to new female patients presenting to a single academic institution specialty clinic. Patients were invited to participate if they were being seen for either SUI or POP. Established patients were excluded from participation. Demographics and responses were recorded and analyzed using Chi-square and Fisher’s exact.
Surveys were administered to patients from March 2013 to November 2013. A total of 208 surveys were collected. The typical presenting patient was 60 years old, Caucasian (87%), married (62%), with at least a high school education (97%) and not currently employed (59%). The majority of patients (62%) surveyed were being evaluated for urinary incontinence which had not been previously treated. Patients were not necessarily aware of different types of incontinence. 104 patients (70%) obtained most of their information about mesh from television. The majority of patients said they were unsure if mesh used for SUI was different from that used for POP (65%), were aware of the FDA safety communication (61%), and believed there was a recall of mesh (50%). In patients who were aware of the FDA announcement, 58% believed there was a recall (p=0.03). For patients who were unsure about different types of mesh use in SUI/POP surgery, they were also unsure or more likely to believe there was a recall (p<0.001). Patients exhibited a bimodal distribution when asked about their anxiety and concern about mesh use.
The majority of new patients presenting to a specialty female pelvic medicine clinic derive most of their information about mesh from television. Interestingly, those aware of the FDA statement associated this with a recall of transvaginal mesh even though patients were not aware of different mesh types for prolapse or incontinence repair. Furthermore, while 24% of patients had significant concerns about mesh use during surgery, many did not. Based on this study, physicians should educate patients about any misconceptions concerning the use of mesh in female urologic surgery when counseling on treatment for POP or SUI.
Authors: Tenggardjaja, Christopher F. (Cleveland, OH); Vasavada, Sandip; Moore, Courtenay; Goldman, Howard B.
Let’s talk about the POOR QUALITY of information that is misleading and biased on the Internet. DOCTORS are misleading and biased and without the Internet women would never live again and would die from mesh complications. I know because I know women with long term complications who will NEVER live a great life even after mesh removal because there was NO information out on the web for many years. But they do live a better life than they were living before mesh was removed and they ARE alive because of this blog and I continue to stay in contact with them. It isn’t me the big headed woman who wants to pump herself up as the savior of all women. I began this blog because of my own mesh complications and women contacted me who wanted to help me find a way to move forward and get better. In exchange for their help, I promised myself I would do more to help other women. And I did and still do. So that is the power of free information by women helping other women.
I can also tell these people that the key words ‘Vaginal POP repair with mesh’ are words someone with medical knowledge would use, NOT mesh injured women. I can also tell them that women don’t look through tons of videos. They seek information either to help them move forward and get well or to move forward without the use of mesh. The number one page of this blog is the page about NON MESH SURGERIES. So whoever you people are you don’t know anything about women or their bodies.
They also have to get past pages and pages of lawyer’s ads and the ads of unscrupulous loan companies and others who are using women to make a profit off of their bodily injuries. So don’t tell the usual press release crap. You have riled me up to do more to get the word out to GET MESH OFF THE MARKET once and for all. I am also raising questions about your stupid study and your ignorance about women.
Introductions and Objectives
Social media networks and websites are an important source of healthcare information exchange. Despite the quantity of information, there is growing evidence for poor quality medical information that may be misleading and biased. Some studies suggest information available online on controversial topics may disperse inaccurate information and contribute to public confusion. The goal of this study is to examine information available in YouTube videos on a controversial urologic topic, pelvic organ prolapse (POP) repairs with mesh.
A keyword search of “vaginal POP repair with mesh” was performed and the first 100 search results examined on 7/29/13. Videos not in English, lacking spoken words, or duration >10 minutes were excluded. Video characteristics including source (legal, medical, other), number of views, time online and duration were recorded. The content of each video was assessed in the following domains: description of POP, management of POP, explanation of the 2011 FDA Safety Communication, and balanced presentation of information. Scores were assigned based on whether the video made a series of objective statements pertaining to each domain. The proportion of statements made in the video per domain was calculated and videos of different sources were compared. Significance was assessed by t test.
51 videos were excluded, and the remaining 49 were viewed. The sources were 69% legal firm, 24% medical institution, and 7% other. The former 2 groups were compared. Videos from medical institutions were older (online for 31.6 vs. 14.2 months, p < 0.01), longer (249 vs 99 seconds, p < 0.01), and had more views per month (784 vs. 140 , p < 0.01) when compared to legal videos. Legal videos explained more aspects of the 2011 FDA Safety Communication (0.22 vs. 0.07; p<0.01). Medical videos did not show a significant difference in addressing aspects of other domains including description of POP (0.25 vs. 0.12, p=0.087), management of POP (0.2 vs. 0.14, p=0.086), or presentation of balanced information (0.10 vs. 0.06; p=.528).
The majority of information available in YouTube videos on the topic of vaginal POP repair with mesh is recent, short, and published through legal services that outline the 2011 FDA Safety communication but contain less comprehensive descriptions of POP compared to other videos. However, low overall scores in all domains studied, regardless of source, demonstrate lack of content. This raises questions about the utility of YouTube as a source of information for patients.
Authors: Sadiq, Areeba S. (New York, NY); Mitchell, Sarah A.; Rosenblum, Nirit; Nitti, Victor W.; Brucker, Benjamin M.
Finally I want you to view the people who are the authors of these studies. Look them up and you will find the following. The one done by UCLA is done by people who remove mesh from women’s bodies every day and the numbers are climbing. They can’t keep up with the number of injured women. Other doctors in some of these studies still continue to use mesh, sign up with loan companies who set up mesh removals against women’s lawsuits, and many don’t have a clue how to remove it without doing further damage or ignoring women when their surgery is not successful. How do I know? I speak to women all the time after they have these surgeries and I know the truth about who these people are.
So YES this blog is completely biased not just by my own mesh injuries, but by all the things I have learned from other women who are equally or far more damaged than I am.
I want women to learn more about press releases and how we are marketed to and why it is important we learn. Check out the Press Release Machine.
I also want them to know the power of this blog. Women can change the lives of other women when they speak out.