Mesh Medical Device News Desk, August 30, 2016 ~ An autoimmune registry is a dream of Hope Pagano, a mesh-injured woman who developed Lupus shortly after her pelvic mesh implant surgery. Hope felt, as many of you do, that someone should be looking at the autoimmune reactions that women with pelvic mesh implanted to treat prolapse or incontinence, seem to be experiencing with alarming consistency.
Is it possible that that polymer is not as biocompatible as the medical device industry promised?
Many Mesh News Desk readers have contributed to the autoimmune registry and your editor contacted UCLA to see if its researchers could do something with this raw data. Today, your editor is happy to announce that UCLA is picking up the autoimmune registry to explore further the associations between polypropylene and other pelvic meshes and autoimmune reactions. Yeah!!!!
Finally - the symptoms are not "in your head" but may someday be quantifiable. MND applauds UCLA for taking this important step!!!
Please feel free to share the survey, which will be conducted anonymously! And if you have contributed to the registry, please take the 15 minutes or so to take the survey so that results can be tabulated into the UCLA database for consistency. You do NOT have to live in the U.S. to fill out the registry. Men with hernia mesh can also participate. You can participate anonymously so please do not be dissuaded from participating! Thank you all!!!
Drs. Shlomo Raz and A. Lenore Ackerman from the Department of Urology at the University of California, Los Angeles (UCLA) are conducting a research study.
If you are a woman who previously underwent pelvic surgery for the treatment of incontinence or pelvic organ prolapse, we invited you to let us know about your experiences through an internet-based questionnaire. Your participation in this research study is voluntary.
Why is this study being done?
In this study, we aim to understand the nature and prevalence of complications after mesh augmented pelvic surgeries for incontinence and pelvic organ prolapse. These conditions affect hundreds of thousands of women each year, many of whom go on to require surgical correction. are frequently managed with surgeries using polypropylene meshes to augment the pelvic floor support structures that are often lacking in these conditions.
In the past few years, however, a number of complications have emerged from the use of transvaginal mesh. A subset of these complications, such as erosion of the mesh into the vagina, bladder perforation, nerve impingement, vaginal scarring, and painful intercourse, have been well-described in the initially efficacy studies examining these products. Recently, a new class of symptoms developing in patients with prior transvaginal mesh surgeries has come to light, including a wide range of systemic symptoms, such as chronic pain, muscle weakness, joint pain and swelling, sinus problems, chronic fatigue, sleep disturbances, cognitive impairment, memory loss, and skin changes.
While concerns about the safety of transvaginal mesh products continues to grow due to anecdotal reports of such complications, a precise definition of symptoms associated with prior transvaginal mesh placement has been lacking. This study seeks to define the types of symptoms reported after mesh-augmented pelvic surgery through the use of anonymous questionnaires.
What will happen if I take part in this research study?
Individuals who agree to participate in the study have previously undergone surgical procedures using augmented polypropylene mesh-based procedure to address pelvic organ prolapse or incontinence. If you agree to participate, you will be asked to fill out a one-time questionnaire on pain, urinary and pelvic symptoms, psychosocial consequences, and quality-of-life and recovery after your operation. All information will be reported by you alone; no personal identifying information will be recorded from other sources.
The questionnaire will take a total of about 20 to 30 minutes to complete. While you will not directly benefit from your participation in this study, the results of the research may be very important in helping physicians and patients better understand the risks and benefits of using graft materials in the repair of pelvic floor disorders. Better characterization of the symptoms and problems resulting from the use of transvaginal mesh will hopefully allow more effective treatment as well as the prevention of these problems in the future.
If you are interested in participating, please click here to take our survey.
Protocol ID:IRB#16-000858 UCLA IRB Approved Approval Date: 6/15/2016 Through: 6/14/2017 Committee: Medical IRB 1