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In a recent statement, the US Food and Drug Administration (FDA) stated that the federal agency is “aware of allegations that Boston Scientific’s urogynecologic surgical mesh may contain counterfeit raw material.”
Currently, the FDA is investigating the allegations in order to determine what it may need to do in response if necessary or appropriate. It also went on to state that it is not uncommon for manufacturers to change the source of raw materials after a device has been cleared by the agency and it does not require the FDA to make a premarket review. The company will also be conducting its own testing in order to establish the safety and effectiveness of its product.
The FDA expects that the testing will take several months and should be sufficient in order to determine if the urogynecological material mesh allegedly made from a counterfeit raw material are equivalent to the original materials used in the product.
The FDA, however, wants healthcare professionals and consumers to be aware and informed of the investigation and the review of additional data that will be provided from Boston Scientific in order to make the best decisions possible concerning their personal health. So far, the FDA is not recommending that women implanted with urogynecological surgical mesh manufactured by Boston Scientific have it removed because the current data does not suggest that it is necessary. Further, the removal of the mesh may cause increased health risks and outweigh any benefits that removal might provide.
The FDA is encouraging both healthcare professionals and their patients to report any adverse side effects due to the use of these products to its MedWatch Safety Information and Event Reporting Program. An online form is available at http://www.fda.gov/MedWatch/report – or they may also call toll free at 800-332-1088 to request a form to be faxed, emailed or mailed to the federal agency.
The use of transvaginal or urogynecologic meshes has been used surgically for many years in the treatment of hernias, incontinence and other issues. Of course, if you or someone you love has undergone surgery for such a condition, the best thing to do is to consult with your physician about any potential risks or any concerns that you may have. Symptoms connected to the use of such urogynecological or transvaginal meshes include infections, severe pain, sexual pain, and a host of other issues.
If you or someone you love has suffered as the result of surgical transvaginal or urogynecological mesh, you may be entitled to compensation. If this describes symptoms you have experienced, then contact the offices of John Foy & Associates to make an appointment to discuss your case. Call the “Strong Arm Attorney” in Atlanta who can help you get the compensation you may be entitled to. Your consultation is both free and confidential.
