INCREASE RISK OF PELVIC MESH SIDE EFFECTS REPORTED IN MEDICAL LITERATURE
Recently, the FDA has issued a Notice that it is reviewing numerous complications and side effects possibly related to defects in the pelvic mesh. The side effects include (1) erosion of the vaginal epithelium, (2) serious infection, (3) recurrence of the pelvic organ prolapse, (4) urinary incontinence, (5) pain during intercourse, (6) severe bleeding (7) bladder perforations, (8) pelvic hemorrhage, (9) bowel perforation, (10) blood vessel perforation, (11) vaginal scaring, (12) mesh erosion, (13) other mesh related complications and (14) dyspareunia. This article addresses other sources of medical literature discussing the same concerns.
Pelvic Mesh, also known as transvaginal mesh, is a type of medical device that is used to treat two common medical conditions: Pelvic Organ Prolapse and Stress Urinary Incontinence. These conditions may occur following child birth and pregnancy. A video of the procedure is avaialble.
Recently, the FDA has issued a Notice that it is reviewing numerous complications and side effects possible related to defects in the pelvic mesh. The side effects include (1) erosion of the vaginal epithelium, (2) serious infection, (3) recurrence of the pelvic organ prolapse, (4) urinary incontinence, (5) pain during intercourse, (6) severe bleeding (7) bladder perforations, (8) pelvic hemorrhage, (9) bowel perforation, (10) blood vessel perforation, (11) vaginal scaring, (12) mesh erosion, (13) other mesh related complications and (14) dyspareunia. The complications are often treated with additional surgical procedures, blood transfusions and IV therapy. The manufactures involved include: Bard (Avaulta Solo Synthetic, Avaulta Plus Biosynthetic, Avaulta Biosynthetic), Johnson and Johnson, (Ethicon TVT, Gynecare TVT, Gynemesh PS, Prolene Polypropylene Mesh Patch, and Secure) , Caldera, Boston Scientific, and Sofradim.
Although the products are widely used, there is little science comparing the pelvic mesh procedures to traditional surgical methods. In a recent comparative study pelvic procedres, Altman reported an increased risk with use of pelvic mesh as compared to alternative traditional methods. Anterior Colporrhaphy is the most common procedure to treat prolapse of the anterior vaginal wall—however, the risk of recurrence is 40% with this procedure. As such, there has been interest in developing new techniques with the hope of better outcomes. Altman conducted a randomized, controlled trial comparing the use of a standardized trocar guided mesh kit with the tradiaional anterior colporrhaphy surgery. The trial was limited to 389 women and the composite was based on both a subjective and objective outcome. While there was a lower rate of recurrence of pelvic organ prolapse after one year, there was a higher rate of adverse events, including bladder perforations, pelvic hemorrhage and mesh related complications. “[The] results highlight the need for careful evaluation of surgical innovations, which are often widely adopted in the absence of data from clinical trials.”
The Altman study follows the FDA Notice in February 2009, where the FDA advised clinicians using the pelvic mesh for pelvic organ prolapse and stress urinary incontinence that the clinicians should: (1) obtain specialized training, (2) be aware of adverse events associated with the pelvic mesh, (3) inform patients of risks and treatment options, and (4) provide patients with the product labeling.
The Altman study also followed an update in the Society of Obstetrician and Gynaecologists of Canada (SOGC) technical literature. The literature recommended the following: (1) patients should be informed that the use of mesh for pelvic floor repairs is considered a “novel technique”; (2) patients should be informed on the range of successes; (3) physicians should undergo specific training for these operations; (4) preoperative counselling should include a discussion of the adverse events that include—mesh exposure, pain, and dyspareunia; and (5) trocarless kits are considered investigative. The guidelines further stated that the following factors may increase the adverse events—(1) lack of full thickness dissection, (2) improper mesh placement, (3) estrogen status, (4) patient nutritional status, (5) BMI, (6) age, (7) smoking, (8) inadequate hemostasis, and (9) immunosuppresion. The guidelines mentioned that the “more than 1000 reports of mesh complication referenced in the FDA notification raised concerns about the adequacy of training, and ability to prevent complications.”
The Lyon Firm is working collectively with counsel around the country representing women affected by these products. If you or a loved one have any questions, please submit your information, and Mr. Lyon will call you for a free confidential consultation.