Transvaginal mesh has become a symbol for all that is wrong with the current system for evaluating medical technology. The product was never thoroughly evaluated for use in pelvic organ prolapse (POP) and stress urinary incontinence (SUI). Because of lax regulation, however, more than a hundred different transvaginal mesh products were cleared for sale by the FDA from 1996 to 2010. As a result, thousands of women have suffered serious injuries with no clear evidence that the technology benefited patients.
In response to complaints and lawsuits, some manufacturers have pulled devices from the market, and makers of devices remaining on the market will be forced to conduct studies to evaluate their safety.
How Transvaginal Mesh Got on the Market Bard Mesh Product
POP and SUI repair are difficult surgical procedures. In both operations, the goal is to provide additional support for organs. This can often be done using only the natural tissue of patient, but to do so requires very invasive surgery that is complicated and requires a long recovery period.
In the 1970s, surgeons began experimenting with the use of hernia repair patches for these surgeries. They cut the patches into custom shapes to account for the relevant anatomy and support needs.
Seeing the potential for a new revenue stream, several manufacturers of hernia patches responded to the demands of POP and SUI surgeons by marketing patches designed for use in these surgeries.
The first transvaginal mesh patch received authorization for marketing in 1996. Boston Scientific’s ProteGen was not approved for SUI. Instead, it was cleared using the FDA’s 510(k) process. The 510(k) process means a device doesn’t have to be rigorously evaluated for safety and effectiveness if it is “substantially equivalent” to a device that has already been evaluated. This means that the new device must have the “same intended use” as an already-evaluated device, called the “predicate.” Boston Scientific convinced the FDA that SUI surgery was the “same intended use” for a mesh patch as hernia repair. As a result, ProteGen was put on the market without rigorous safety testing.
Once Boston Scientific had made the leap from hernia repair to SUI, Johnson & Johnson, Bard, Covidien, American Medical Systems, and others just compared their transvaginal mesh products to ones already on the market. None of them was ever rigorously evaluated for safety and effectiveness.
Transvaginal Mesh Problems Begin
ProteGen was cleared for market in 1996. Johnson & Johnson’s Gynecare TVT (Transvaginal Tape) was cleared in 1998. By that time, Boston Scientific had already received more than a hundred complaints of surgical complications associated with ProteGen, and voluntarily recalled more than 20,000 devices.
However, Gynecare TVT and hundreds of other devices considered “substantially equivalent” to ProteGen, remained on the market, with serious consequences.
According to the FDA in September 2011, there were about 1500 reports of complications associated with the use of transvaginal mesh for POP in 2008-2010, and nearly 1400 complications associated with the use of transvaginal mesh for SUI during the same period. This includes ten deaths.
Other complications associated with transvaginal mesh include:
- Erosion of organs and flesh by transvaginal mesh
- Urinary problems
- Organ perforation
- Recurrence of original condition
- Painful intercourse
These often require additional medical procedures to treat.
Following these complications, people have begun filing lawsuits seeking compensation for injuries suffered. Hundreds of lawsuits have been filed against transvaginal mesh manufacturers for medical expenses, pain, suffering, and diminished quality of life. Some have been dismissed, but others have succeeded.
In one of the first cases to go to trial, a California woman and her husband were awarded $5.5 million by a jury for injuries suffered due to transvaginal mesh surgery. The mesh manufacturer, C.R. Bard, Inc., was ordered to pay its share of the verdict, $3.6 million (more than 60%), but the doctor’s share of liability will be determined in a separate case.
Most of the remaining lawsuits have been consolidated into Multi-District Litigation being conducted in West Virginia. Evidence gathering is currently taking place and the first case should be heard in February.
FDA and Industry Response
In response to the thousands of complaints, the FDA has issued a number of cautions to doctors and patients about transvaginal mesh. These include a 2008 Public Health Notification and a 2011 Safety Communication. It also asked that mesh manufacturers be required to conduct safety and effectiveness studies before marketing new transvaginal mesh products, and conduct studies on products already on the market.
Some manufacturers have responded to health and safety information and the new requirements by pulling their transvaginal mesh products. In June 2012, Johnson & Johnson announced it would stop selling transvaginal mesh. In July, Bard also decided it would stop selling its transvaginal mesh rather than comply with the new study requirements.
It is hoped that with the new requirements, we will finally know whether these products are truly dangerously defective or if they can be used safely in some situations.