At the time investigations into polypropylene vaginal mesh cases began, these products were widely considered the gold standard for surgical repair of urinary incontinence and pelvic organ prolapse. Manufacturers—including Johnson & Johnson, Boston Scientific, C.R. Bard, and American Medical Systems—marketed the mesh as safe, inert, and materially similar to mesh products long used in hernia repair procedures.
The primary challenge was uncovering the true biological reactions and risks associated with these devices, which were aggressively promoted to physicians and patients as both practical and low-risk. This required an intensive and multi-faceted investigation into the history, chemistry, and clinical performance of the polypropylene material used in these implants.
Through extensive research, the investigation team tracked down the family of the original patent holder for the mesh material. Their archives—including original sketches, notes, and prototype models—provided critical insights into the limitations and concerns surrounding the material’s long-term stability and interaction with human tissue. The team also engaged with concerned physicians, researchers, and citizen advocates who had independently raised alarms about the safety of these devices.
To strengthen the scientific foundation of the claims, leading biomedical experts were retained to conduct independent testing and evaluation of the mesh products. Over time, the investigation uncovered critical internal documents from the manufacturers, including a Material Safety Data Sheet (MSDS) for the raw polypropylene resin, explicitly warning, “Do not use in permanent human implants.” This document, among others, revealed that manufacturers were aware of significant risks but chose to conceal them from regulators, physicians, and patients.
The investigation helped expose a widespread pattern of scientific misrepresentation and marketing deception that ultimately harmed hundreds of thousands of women. The litigation evolved into the largest and most complex consolidated products liability action in U.S. history up to that point, resulting in the recall or market withdrawal of numerous mesh products. Billions of dollars were ultimately recovered through settlements, and numerous multimillion-dollar jury verdicts were awarded to injured plaintiffs.
This public health disaster could have been prevented with proper scientific research, corporate transparency, effective regulatory oversight, and adequate warnings. Instead, corporate greed, reckless disregard for patient safety, and systemic regulatory failures enabled one of the most damaging medical device scandals in modern history.