Alarming FDA Facts Regarding a Vaginal Mesh Implant

Urogynecological vaginal mesh implants are medical devices used as treatment for pelvic organ prolapse (POP) and stress urinary incontinence (SUI) conditions. Both conditions may require a transparent and synthetic vaginal mesh to be inserted, anchored and stitched into the vagina. By doing so, the pressure placed on the vaginal walls as a result of the prolapse may be lessened. Regrettably, this procedure may not always call for happy and successful surgeries. This is because of the rising numbers of vaginal mesh plaintiffs complaining and filing lawsuit cases against various mesh manufacturers, as stated by the Food and Drug Administration (FDA).

The Food and Drug Administration is an agency of the Department of Health and Human Services which acts like a regulatory board for medical products like the vaginal mesh. This means that before a product is made open to the public, a pre-market approval from the board is necessary. On a closer look, the medical world is swamped with all sorts of medical products and it may not be possible for the FDA to look into every single product. This is probably the reason why the agency has a 510(K) food, drug and cosmetic act. According to this act, a manufacturer must submit a pre-market application stating the usage and classification of their medical product 90 days in advance of its release. If the said product has the same classification of another similar product that has been previously approved then there may be a lesser need for extensive product testing, if any.

In 2008, the FDA released a safety communication update stating that vaginal mesh complications were serious, albeit rare. However, in 2011, the FDA released another safety communication update stating that complications arising from a vaginal mesh implant were serious but not as rare as they originally concluded. Because of these updates, many physicians and urogynecological experts have suggested that extensive testing and analysis be done before approving a new medical device.

For the duration of 1 January 2005 until 31 December 2007, the FDA had received over a thousand complaints in regard to a vaginal mesh implant. For the duration of 1 January 2008 until 31 December 2011, vaginal mesh implant complaints nearly reached 4,000. Due to these complaints, the FDA released a medical device notification in July of 2011 with regards to a vaginal mesh implant. In this alert, the board recommends doctors to enhance their expertise and capability of handling a vaginal mesh surgery. Patients, on the other hand, were advised to gain awareness of all the complications that might arise from a vaginal mesh procedure. Some of these complications may include vaginal erosion, pelvic organ perforation, infections, bleeding, urinary problems and pelvic pain.

REFERENCES:

fda.gov/AboutFDA/CentersOffices/default.htm

fda.gov/medicaldevices/deviceregulationandguidance/howtomarketyourdevice/premarketsubmissions/premarketnotification510k/ucm070201.htm

fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm262435.htm

bloomberg.com/news/2011-10-20/j-j-vaginal-mesh-approved-by-fda-based-on-older-recalled-device.html

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