September 8-9, 2011 will witness an advisory committee of the U.S. Food and Drug Administration (FDA) convene to discuss the future of transvaginal mesh products. The Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee hopes to present the FDA with substantial evidence pertaining to the use of transvaginal mesh. However, the FDA’s main concern is to determine the safety and effectiveness of these devices. Prior to the meeting, the FDA has devised a list of premeditated questions that will help identify the safety and effectiveness concerns associated with vaginal mesh used for pelvic organ prolapse (POP) repair. Subsequently, preparations such as this will help determine whether the evidence shows that clinical benefits outweigh the risks.
The meeting has allotted a specific time in which the FDA will be allowed to ask the advisory committee any pertinent questions regarding the safety and effectiveness of transvaginal mesh products in the treatment of pelvic organ prolapse. The questions proposed by the FDA will provide significant insight to further actions or regulations taken by the agency.
According to panel discussion questions, the FDA will emphasize the importance of the safety of vaginal mesh used to treat POP. By evaluating the risks associated with vaginal mesh, the FDA may determine a standard level of regulatory control necessary to provide adequate assurance of the safety and effectiveness of the product.
After an investigation of medical device reports obtained from the Manufacturer and User Facility Device Experience (MAUDE) database, the FDA gained access to scientific literature that identified numerous peri-operative and long-term risks associated with transvaginal mesh in POP repair. The following is a list of the reported risks:
- Organ perforation
- Bleeding (including hemorrhage and hematoma)
- Pain
- Infection
- Dyspareunia
- Revision surgery
- Vaginal mesh exposure
- Mesh erosion into bladder or rectum
According to premeditated panel discussion questions, the FDA will request the advisory committee to comment on the accuracy of these risks and whether they capture the most serious complications associated with the surgical application of transvaginal mesh. In doing so, the FDA will determine if there is a reasonable assurance of the safety of transvaginal mesh.
In continuing with their attempt to determine the adequate assurance of safety and effectiveness, the FDA will ask the committee to present the counsel with substantial evidence that suggests transvaginal mesh provides clinical benefits over traditional procedures. Subsequently, these questions asked by the FDA will help to determine if the benefits of transvaginal mesh outweigh the risks. While the safety and effectiveness of transvaginal mesh remains a top priority, premeditated panel discussion questions reveal that the FDA is also concerned with the reclassification of the products.
An influx of adverse events associated with the surgical application of transvaginal mesh has become a concern in the healthcare community. Many people feel that reclassifying transvaginal mesh products will help with regulation. At the center of FDA questions regarding the reclassification of vaginal mesh from Class II to Class III is whether clinical studies should be required before pre-market clearance, and if so, whether those studies should be designed with a non-mesh control arm. Subsequently, the FDA wants to know if there should be a clinical study for the pre-market evaluation of transvaginal mesh. Pre-market studies will help to gain a better knowledge of the products and their potential complications.
However, the FDA is concerned that the safety and effectiveness of currently marketed vaginal mesh for POP repair are not adequately understood. The FDA believes that manufacturers of such products should conduct post-market surveillance studies of devices on the market to address these outstanding concerns. Mandating post-market surveillance studies could begin in concert with the process of reclassification from Class II to Class III, but still may be performed if these devices remain Class II.
The previously mentioned questions are intended to assist the FDA in identifying the safety or effectiveness concerns associated with vaginal mesh used for POP repair and determining whether the evidence shows that the clinical benefits outweigh the risks. The answers to these questions will play a critical role in future regulations of transvaginal mesh products.
Do I Have a Transvaginal Mesh Lawsuit?
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Again, if you or a loved one has been injured by transvaginal mesh, you should contact our lawyers immediately by clicking the link below or calling toll free 1-(949) 557-5800. You may be entitled to compensation for your injuries and we can help.