A consistent chain of behavior demonstrates Ethicon’s disregard for patient safety, making profit its first priority, and dragging its heels on reprinting mesh instructions with proper warnings.
On November 29th, company officials from Ethicon, a Johnson & Johnson unit, presented deposition testimony admitting the company was aware of potential complications related to a mesh medical device prior to its launch in 2005.
Complications Caused by Mesh Products
The problems with mesh are two-fold: the product itself is defective and the manufacturers do not adequately inform or train the surgeons they persuade to use the mesh. Thousands of women have experienced serious complications from transvaginal mesh and bladder sling surgeries. The mesh can erode and migrate through the vaginal wall, causing excruciating pain, infection, and bleeding. Often these problems can be corrected only by additional surgeries, which are extremely complicated because the mesh imbeds itself into the surrounding tissue and is difficult to surgically remove. To make matters worse, it is not always easy to find a skilled surgeon willing to perform corrective surgery. And it may take more than one surgery to correct the problem.
Questionable Actions Affect Patient Safety
In a 2012 video deposition, when asked about whether there were any risks or adverse events associated with the device that the company’s medical affairs department knew about when the product went on the market, Ethicon’s director of medical affairs withheld the truth saying there were no adverse events that they were aware of at the time of launch.
Prior to Ethicon selling its Gynecare Prolift pelvic floor support mesh product, a company engineer recommended that Ultrapro mesh be used for floor repair instead because it would reduce erosion and the formation of scar tissue. Three months later, the same engineer cited scarring problems associated with Gynemesh PS, a prolene soft mesh used in the newly released Prolift.
Even when doctors reported problems with patients who were implanted with Prolift, Ethicon continued to choose profit over patient safety saying that it is impossible to calculate an ‘“algorithm to say if we reach this limit of adverse events, that becomes a reason to stop selling”’ the product.
Thousands of women across the country have filed Ethicon mesh claims. The company began selling the device without giving doctors a warning related to patient sexual intercourse.
After an Ethicon doctor suggested a warning, a regulatory affairs employee for Prolift said that the product’s instructions for use were most likely already printed and that the document should probably be left as is unless the change was absolutely necessary. To compound this, a research and development project leader for Prolift responded by saying that the suggested warning would be a “next rev addition” since they had already printed labels and the products were needed ASAP.
During video deposition, it was admitted that the decision about adding the warning to the label should not have been driven by whether the document needed to be reprinted because it could jeopardize patient safety.
What does the FDA Say About Transvaginal Mesh?
In July 2011, the U.S. Food & Drug Administration (FDA) issued a Safety Communication, warning that serious complications with transvaginal mesh surgery are not rare. Further, the FDA cautioned, it is not clear that transvaginal mesh surgery is more effective for repairing POP (pelvic organ prolapse) than the traditional surgical approach. In January 2012, the FDA went further to announce that it may decide to reclassify transvaginal mesh from Class II to Class III. The FDA’s Class III medical devices are the most risky of all, require greater regulation, and usually need FDA approval before they can be marketed.
How can Waters Kraus & Paul Help?
Waters Kraus & Paul enjoys a national reputation and a wealth of experience representing clients injured by dangerous products and unsafe medical devices. We understand that transvaginal mesh is a women’s issue. Injuries caused by transvaginal mesh are personal and they’re sensitive. To learn more about Waters Kraus & Paul, or to have one of our vaginal mesh attorneys review your potential transvaginal mesh case, email us or call 800.226.9880.