What are they?
Clinical studies are conducted to allow doctors and researchers to collect medical information to answer a specific health question. The question may be about how safe and effective a new or existing product is, either by itself, or when compared to other products, or it may be to see if any existing product can be used for a different condition. These studies are sometimes required by the FDA to show that a product is safe and effective before it is marketed, or to show long-term safety after it is on the market. Study participants are volunteers that agree to allow their doctor to collect information about their experience with a product in very controlled conditions.
The FDA has required that the manufacturers of mesh and animal derived biologic grafts used transvaginally for pelvic organ prolapse and stress urinary incontinence conduct post-market studies to show that the products are both safe and effective, when compared to patients who have surgery without a mesh. If you are interested in participating in these clinical studies, you can learn more about them on the FDA Response page, or view a list of studies currently recruiting patients at clinicaltrials.gov.
Published Clinical Trials
The results of clinical studies are available to the public after it is completed. These results are published in medical journals and may also be available on the internet. If you are considering an implant or volunteering for a study, be sure to ask your doctor what current information may be available for the product or procedure you are considering. Your doctor can help you understand the results and the difference between studies for similar products or procedures.
One important variable that cannot be controlled for in a clinical study is the surgeon performing the procedure. The results of each study are specific to the surgeons involved in that study. It is important to ask questions about your own surgeon’s experience with pelvic floor reconstruction surgery, as it is a very specialized area of surgery. Talk to your surgeon about their experience with various treatment options and their success rate with each, including in patients with conditions similar to yours.
Generally, clinical trials involving an implant study only one manufacturer’s implant to control for that variable. Because studies are specific to a product, it is important to note—as physicians do—that there are only certain principles that can be applied to cases using a different implant. Plan to look for the clinical data available specific to the implant that you will be receiving.