Sam Brusco, Associate Editor03.25.21
Boston Scientific has agreed to pay $188.6 million to resolve allegations about deceptive marketing of its transvaginal surgical mesh that endangered the health of women. The multistate investigation found the company violated state consumer protection laws by misrepresenting the devices’ safety and effectiveness, and failing to sufficiently disclose risks associated with use.
Transvaginal surgical mesh is a synthetic woven fabric implanted in the pelvic floor to treat stress urinary incontinence and pelvic organ prolapse in women. Although using the surgical mesh involves risk of serious and irreversible complications and isn’t proven to be more effective than traditional tissue repair, millions of women were implanted with the mesh and thousands have alleged to have suffered serious complications.
Boston Scientific must also undergo a number of marketing, training, and clinical trial reforms for the transvaginal surgical mesh.
In October 2019, a multistate settlement required Johnson & Johnson and subsidiary Ethicon to pay almost $117 million for deceptive marketing of its transvaginal surgical mesh devices. In September 2020, CR Bard and parent company Becton Dickinson paid $60 million for the same.
Transvaginal surgical mesh is a synthetic woven fabric implanted in the pelvic floor to treat stress urinary incontinence and pelvic organ prolapse in women. Although using the surgical mesh involves risk of serious and irreversible complications and isn’t proven to be more effective than traditional tissue repair, millions of women were implanted with the mesh and thousands have alleged to have suffered serious complications.
Boston Scientific must also undergo a number of marketing, training, and clinical trial reforms for the transvaginal surgical mesh.
In October 2019, a multistate settlement required Johnson & Johnson and subsidiary Ethicon to pay almost $117 million for deceptive marketing of its transvaginal surgical mesh devices. In September 2020, CR Bard and parent company Becton Dickinson paid $60 million for the same.
