Defective Transvaginal Mesh Products Terms Guide offered by Jewish Doctors Network
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Also known as a pelvic sling, bladder mesh, indicates that vaginal mesh bladder sling,Gynecare Prolift, Bard Avaulta, Boston Scientific Pinnacle and Uphold, and AMS (American Medical Systems) Apogee, Perigee, and Elevate or transvaginal mesh vaginal mesh support systems are used to help with pelvic organ prolapse as well as urinary incontinence They can cause serious internal injuries. These transvaginal mesh patch implants, manufactured by Johnson & Johnson and C.R. Bard, Boston Scientific, American Medical Systems, and others, may cause pain, infection, erosion, organ damage, and additional surgeries, and other vaginal mesh injuries.
Bard Avaulta: The family of synthetic mesh products manufactured and distributed by the Medical Division of C.R. Bard, Inc. The company’s transvaginal mesh products include Bard Avaulta Biosynthetic (a polypropylene mesh with a hydrophilic collagen coating that is available in a kit for anterior or posterior implantation), Bard Avaulta Plus (a polypropylene mesh with a matrix of cross-linked collagen on one side of the mesh that, in appearance, resembles a woman’s panty liner product) and Bard Avaulta Solo (a polypropylene mesh support without additive products).
Bladder: A muscular and elastic organ that sits on the pelvic floor and collects urine excreted by the kidneys. In a female, the uterus sits posterior (behind) to the uterus and anterior (before or in front of) to the vagina. Urine passes from the bladder outside the body through the urethra. Pelvic organ prolapse arises when the bladder "drops" out of place, while stress urinary incontinence stems from the inability to control the bladder.
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Colostomy: A procedure that may be required on a temporary or permanent basis when complications are caused by defective transvaginal mesh. The procedure involves creating an opening that provides an alternative way for feces to be discharged from the body.
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Cystocele: This condition occurs when weak or damaged pelvic floor muscles allow a woman’s bladder to "drop" into the vagina, which can stretch the opening into the urethra and cause urinary incontinence (or leakage). This condition is sometimes called "dropped bladder." Transvaginal mesh has been implanted in women to keep the bladder in its normal position and add support to pelvic floor muscles so the bladder remains in place.
Dyspareunia: A condition that occurs when a woman experiences pain before, during or after sexual intercourse. It is sometimes called "sexual pain." This is a significant complication in women who have received transvaginal surgical mesh implants.
Enterocele: This condition arises when the small intestine falls or "prolapses" into the lower pelvis and pushes at the top portion of the vagina, creating a bulge. Also called a "vaginal hernia," this often occurs in women who have had their uterus removed in a hysterectomy.
Erosion: This occurs when polypropylene mesh erodes through tissue after being implanted in a women’s pelvis area. This is sometimes called "vaginal mesh erosion." Signs that the mesh erosion has occurred include infection, inflammation, bleeding, pain during sexual intercourse or a general pain in the pelvic area.
Gynecology: The area of medicine that focuses entirely on the health of the female reproductive system, including the vagina, uterus and ovaries. Generally, gynecologists treat and, in some cases, surgically repair pelvic organ prolapse and stress urinary incontinence by implanting synthetic mesh into the women’s pelvic area.
Hysterectomy: The partial or total removal of a woman’s uterus through a surgical procedure. Because of the significant consequences of a hysterectomy, including a prevention of future childbirth and a change in hormonal levels that may weaken pelvic floor muscles, this procedure is performed as a last resort.
Infection: A condition triggered by bacteria or germs growing within the body. Infections can lead to a great deal of pain and discomfort. One of the complications of transvaginal mesh erosion has been infections in the body.
Inflammation: The body’s response to material implanted in the body, marked by pain, swelling, redness and fibriotic reaction. Inflammation can occur when a transvaginal mesh product shrinks, curls, rolls, degrades or migrates in a woman’s body.
Medical device: The U.S. Food and Drug Administration (FDA) defines a medical device as any non-chemical "instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory" that is intended to affect the structure or any function of the body. Transvaginal mesh fits within this definition of medical device, and, as such, it is subject to FDA regulations to allow marketing of the product.
Menopause: This occurs when a woman goes 12 months with no menstrual period. Menopause is marked by a loss of estrogen, the hormone which strengthens pelvic floor muscles. It is believed that menopause can lead to pelvic organ prolapse, where weakened muscles allow pelvic organs to fall from their normal positions.
Pelvic organ prolapse (POP): A condition in which pelvic organs and tissue, such as the bladder, uterus, vagina, small intestines and rectum, fall or push toward the outside of the woman, such as pushing against the vaginal wall. It is caused by weakened or damaged pelvic floor muscles that result from childbirth, chronic constipation, congenitally weak pelvic tissues, hysterectomy, trauma, aging (menopause) and heavy lifting. This condition is often described in terms such as "the bladder has dropped," "the uterus has fallen" or "pelvic pressure."
Pelvis: The lower part of the abdomen that is located between the hip bones.
Perforation: A tiny hole. One of the potential complications of transvaginal mesh implants is that the material will perforate pelvic organs, such as the bladder, which requires immediate medical treatment.
Polypropylene mesh: Thermoplastic mesh that is commonly used in hernia repair operations and, more recently, in treatment of pelvic organ prolapse and stress urinary incontinence. The mesh is intended to strengthen and support weakened pelvic floor muscles and tissues. However, because the mesh may not function properly in the pelvis, it can lead to serious post-operative complications. In October 2008, the FDA issued a warning about the use of polypropylene mesh implants in the pelvic area.
Product implant sticker: A sticker generally obtained from a hospital’s medical records department that indicates the make, manufacturer, model, lot number, expiration date and other information for the surgical mesh kit used to treat a patient with pelvic organ prolapse or stress urinary incontinence.
Product liability: A legal cause of action that arises against a manufacturer, distributor, retailer or any other party in the chain of distribution when a person suffers injury caused by a defect in the product. A lawsuit against the manufacturer of a defective transvaginal mesh product would be considered a product liability lawsuit.
Rectum: The last segment of the large intestine that stores fecal matter until it is discharged from the body through the anus. Transvaginal mesh products have been used to return the rectum to its normal position when it has fallen out of place. Unfortunately, rectal problems have arisen from the mesh product used in this surgical procedure.
Rectocele: This occurs when weakened tissue separating the rectum from the vagina allows the front wall of the rectum to press into the vagina. This can be a very painful condition, and many women have sought relief by undergoing a transvaginal surgical mesh procedure.
Scarring: This occurs when scar tissue (fibrosis) replaces normal tissue that has been damaged as the result of trauma or disease. The scar tissue generally does not perform as well as the tissue it replaces. Scarring is a complication that is caused by surgical mesh.
Stress urinary incontinence (SUI): A condition that arises from the urethra being unable to control urine flow from the bladder, which results in the sudden and uncontrollable loss of urine, or urine leakage, when a person coughs, sneezes, laughs or engages in any activity that may put pressure on the bladder, such as lifting heavy objects or exercising. The condition is sometimes called "urinary incontinence."
Symptoms: When bodily function or feeling noticeably departs from what is normal. For instance, people with pelvic organ prolapse may feel sharp pain in their pelvic area, while women with stress urinary incontinence may experience uncontrolled urination when laughing, sneezing or coughing. Although transvaginal mesh products are intended to treat these symptoms, many female patients experience a recurrence of symptoms.
Tissue: A group of cells that combine to perform specific functions. When tissue is damaged or harmed by disease, it may lead to scar tissue forming that does not function as well as the original tissue.
Transvaginal mesh: A generic term for different brands of synthetic mesh that are used to treat conditions such as pelvic organ prolapse and stress urinary incontinence. The mesh is frequently a form of propylene mesh. It is implanted by inserting the mesh in the vaginal area through small incisions. Transvaginal mesh products are often referred to as mesh patches, mesh kits, vaginal tape, transoperative tape, bladder slings, vaginal slings or urethral slings. The surgical procedure is commonly called pelvic reconstruction surgery or TVM surgery.
Trauma: An injury that occurs due to a tear, perforation, cut, scrape or blunt force. When pelvic floor muscles are subjected to trauma during vaginal childbirth or surgery, conditions such as pelvic organ prolapse may occur.
Urethra: The tube leading from the bladder through which urine is discharged. In a woman, the urethra is located above the vaginal opening. Muscles located at each end of the urethra, or urethra sphincters, control the flow of urine. When these muscles are damaged or weakened, it can trigger stress urinary incontinence.
Urology: The area of medicine that focuses on the urinary tract, including the kidneys, adrenal glands, ureters, urinary bladder and urethra. Urologists may use transvaginal mesh to treat conditions such as pelvic organ prolapse and stress urinary incontinence.
Uterus: The organ located in a woman’s abdomen between the bladder and rectum. A uterine prolapse occurs when the uterus moves from its normal position because of weak or damaged muscles, causing tremendous pain in the pelvic area.
Vagina: A muscular canal that stretches from the cervix to the outside of the body. A pelvic organ prolapse occurs when an organ such as the uterus, rectum, small intestines or bladder falls out of position and causes a bulge in the vaginal wall. To treat this condition, many women have been implanted with surgical mesh that has, in turn, caused painful complications.