Medical device maker Boston Scientific has revealed that California’s Attorney General has launched an investigation into sales of its transvaginal mesh devices.
The company also faces a whistleblower lawsuit over alleged illegal sales of a spinal stimulation device. The company is seeking to have that lawsuit dismissed after the federal government declined its option to join.
Boston Scientific is one of several medical device makers that is being forced to answer more questions than it had bargained for surrounding the sale of transvaginal mesh devices. Transvaginal mesh devices have been linked to a growing number of complications after they’ve been implanted in women. Tens of thousands of women have been implanted with an array of mesh devices in the treatment of stress urinary incontinence or pelvic organ prolapse.
A transvaginal mesh device is typically implanted in the walls of the vagina but for many recipients, the device malfunctions and causes numerous problems, including erosion of the tissue and skin, severe pain, inflammation, infections, and a breakdown of the device. Many who’ve received the devices have undergone several surgeries in an attempt to remove them to relieve themselves of these problems. In some cases, the corrective surgeries are unsuccessful, leading to frustration, rising medical costs, and persistent pain for women.
Many women describe unbearable pain and an inability to lead a normal life, unable to sit or stand in one place for too long before pain builds-up. These are undoubtedly the cause of the defective transvaginal mesh products.
Transvaginal mesh devices were largely approved through the Food and Drug Administration’s 510(k) “fast-track” approval system, which allows new devices on the market based on the fact that it mirrors a design from a previously-approved product. The system has less stringent requirements on pre-market safety testing.
Boston Scientific, according to a report at MassDevice.com, is currently facing at least 2,500 product liability lawsuits over its line of defective transvaginal mesh devices. The company said that in addition to the recently-launched California investigation, several other state attorneys general have launched separate investigations.
Concurrently, the Food and Drug Administration has recently ordered the makers of transvaginal mesh devices, including Boston Scientific, to submit post-market clinical testing to show that transvaginal mesh is a safe surgical device.