The legal controversy surrounding transvaginal mesh procedures is nothing new. The complications with surgeries, warnings from the U.S. Food and Drug Administration, abounding lawsuits, and unhappy patients seem to be ever-present in the media. However, something that may have been flying under consumers’ radars is that some drug manufacturers are under scrutiny for deliberately withholding vital information from consumers.
On Aug. 8, 2012, New Jersey judge, the Honorable Carol E. Higbee, issued an Order for drug manufacturer Ethicon to release all of their communications with the U.S. Food and Drug Administration (FDA). Ethicon is a subsidiary of healthcare superpower Johnson & Johnson. Higbee has presided over all transvaginal mesh (TVM) lawsuits filed in New Jersey state court. Although FDA warnings for TVM cases have been in effect since 2008, after thousands of cases Judge Higbee continues to crack down on these companies to hold a high standard of transparency.
The mesh treatment was originally known as the magic cure for urinary issues and bladder, bowl and uterine prolapse. Over time, procedure complications can cause mesh erosion, contraction, migration and exposure, as well as the formation of scar tissue.
Even with the proof of the dangers of mesh products, drug manufacturers continued to manufacture and market the harmful devices. How could this happen? An FDA loophole. The 510(k) process speeds up the marketing of “low to moderate risk” medical devices. In this process, no clinical trails are necessary to prove the safety of a product if it is substantially similar to those already on the market.
Even after thousands of hurting patients speaking out about surgery complications and lawsuits, drug manufacturer, Ethicon, continued to promote their faulty products nine months after the FDA ordered a halt on sales. Now the company is defending more than 1,400 transvaginal mesh implant lawsuits in both federal and state courts.
The court order issued by Judge Higbee last month shows that the struggle between secretive drug manufacturers and wrongfully harmed patients is far from over. Have you been relying on assurances from drug companies? It should be the responsibility of the medical community and the FDA to ensure the safety of U.S. consumers of medical devices. Don’t take drug manufacturers at face value. If you have been wrongfully affected by a transvaginal mesh procedure, you may have a case.
At Borchardt Law Firm, we wish for no family to ever experience incapacitating tragedies due to defective medical devices. Our firm has the experience and the drive necessary to continue to strive for the improved protection of future generations of Texans. If you or a loved one have ever suffered from a related misfortune and feel you were not properly warned about the potential risks, don’t hesitate to contact a lawyer to discuss any legal compensation you might be entitled to. Borchardt Law Firm represent clients over many areas in Texas; feel free to give us a call.
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