Important News from Your Texas Accident Lawyer
Public Citizen Petitions the FDA to Recall Synthetic Mesh Used for POP
Posted on Aug 28, 2011
Ralph Nader's Public Citizen petitioned the FDA to issue a recall on all synthetic, non-absorbable mesh products used in transvaginal surgical repairs of POP (pelvic organ prolapse). Public Citizen echoes the recent FDA warning on mesh products. The organization says that the non-absorbable mesh products offer no especial benefits to patients, but rather expose them to serious risks and the possibility of "permanent life-altering harm."
Public Citizen calls on the FDA to:
* Ban the marketing of the synthetic, non-absorbable mesh products used in transvaginal surgical POP repair;
* Order manufacturers to recall all of these products from the market;
* Require that any future devices of this type be classified as Class III medical devices; and
* Subject these devices to more stringent approval requirements including mandatory testing.
Public Citizen notes that women whose transvaginal POP repair surgeries involved the use of non-absorbable mesh did not experience better outcomes regarding symptom relief or quality of life than those whose surgeries did not use the mesh. Symptom relief and improved quality of life are the measures of a successful treatment outcome for POP.
If you are one of the thousands of women whose POP repair surgeries have caused you more harm than good, perhaps we could help. At Denena & Points, we are dedicated, Board Certified personal injury attorneys with long-term experience handling medical device cases. Our in-depth knowledge and understanding of medical devices and their effects on the patient could benefit you in your quest to recover fair financial compensation for the harm you have suffered because of a failed POP repair.
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