C.R. Bard, subsidiary of Becton Dickinson & Co. announced it would be removing its pelvic organ prolapse and stress injury devices for women from the European market. The announcement came from a posted field corrective action from Bard, dated March 7, 2019.
The company emphasized this is not a recall. Rather, Bard said it would be ceasing production and distribution of its devices from hospitals and distribution centers. “This product removal has not resulted from any safety concerns regarding these devices and no additional follow-up activities are required for patients already treated with the devices,” the notice stated.
Bard suggested removal of the implanted devices from patients is unnecessary. The affected products are various versions of the Align, Ajust, Avaulta, Alyte and Nuvia systems. For a comprehensive list, please visit page 3 of the announcement here.
Over the years, Bard has been lumped into the worldwide controversy over mesh implantation device failure. Many men and women across the world suffer from hernias and mesh implants are typically the go-to for surgeons to repair the bulging and painful tissue disorder.
Women, in particular, have claimed defective mesh implants such as Bard have exacerbated their pelvic organ prolapse (POP) and stress urinary incontinence (SUI) issues; ranging from reparative surgery to abdominal perforation.
In 2016, the US Food and Drug Administration issued a press release with details about reclassifying transvaginal mesh products from Class II to Class III. This generally includes medical devices, such as hernia mesh, as being labeled “high-risk” factors for jeopardizing a patients’ health.
The report outlined an increase in serious adverse events associated with POP and SUI devices. Numerous manufacturers of transvaginal mesh have shelled out millions of dollars in settlements with victims due to this.
Bard recently won an appeal lawsuit that involved a woman who died after having one of its surgical mesh devices implanted to repair a hernia. Though her case foiled, there are many more who may be suffering.