On January 20, 2012, Representative Henry Waxman of California led House Democrats from the Energy and Commerce Committee in writing a letter to several chairmen, requesting that the Committee hold hearings to review the safety of vaginal surgical mesh products and other medical devices implanted into patients. The congressmen also requested that the Committee demand documents related to the urogynecologic surgical mesh products as well as other medical devices. In the letter, the congressmen noted that they previously submitted a request for these hearings on October 12, 2011, which never materialized. Specifically, the October 12, 2011 letter requested that an investigation into metal-on-metal hip implants, as well as brain stents be commenced. In the recent letter, the congressmen stated that they “remain concerned that the Committee’s previous hearings on medical devices have presented a skewed and inaccurate picture of the importance of appropriate medical device regulation.” In support of this latest request, the congressmen cited transvaginal mesh complications stemming from urogynecologic surgical mesh products as well as problems with other medical devices.

Transvaginal Surgical Mesh Products Cited As Example Of Flawed FDA Approval Process

In support of their request, the congressmen argued that transvaginal surgical mesh products received market approval by the U.S. Food and Drug Administration (“FDA”) through the 510(k) clearance process. The FDA did not require original clinical studies before approving the transvaginal mesh implants through the 510(k) process. In response to the growing numbers of transvaginal mesh complications that have been reported, in October 2008, the FDA issued a Public Health Notification, stating that transvaginal mesh complications were “an area of continuing concern.” In the three years prior to the October 2008 notification, the FDA had received over 1,000 adverse event reports of transvaginal mesh complications experienced by women who received the surgical mesh products. Over the course of the next three years, the number of reported transvaginal mesh complications topped 2,800, prompting the FDA to issue an update on the “serious complications” associated with vaginal mesh in July 2011. On January 3, 2012, as part of its ongoing safety review of transvaginal surgical mesh products, the FDA ordered pelvic mesh manufacturers to study rates of side effects and transvaginal mesh complications such as organ damage, infection and painful sexual intercourse, which have been linked to these surgical mesh products. More than 30 medical device manufacturers were asked to provide data on the safety and effectiveness of transvaginal mesh implant procedures. Johnson & Johnson and C.R. Bard Inc. were among those contacted. Consequently, the congressmen noted that “[i]t is unclear when the manufacturers of this device became aware of the serious health risks associated with the device. It is also unclear if the manufacturers and the FDA have taken appropriate steps to protect patients.”

Transvaginal Surgical Mesh Products Are One Of Many Medical Devices That Should Be Reviewed

In addition to outlining issues associated with transvaginal mesh complications reported by women who received the surgical mesh products, the congressmen reiterated that “the Committee should hold hearings to examine whether FDA device regulation has been ineffective in protecting the public from dangerous medical devices . . . [The Committee] should hold hearings on the brain stents and metal-on-metal hip implants mentioned in [the] October 12 letter.” Finally, the congressmen asked the Committee to “seek documents from the manufacturers of surgical mesh to ascertain when they first learned of safety issues associated with certain uses of the device and what, if any, actions they took to limit risks for patients.” The congressmen stressed the need for prompt action given that the Medical Device User Free Act is approaching reauthorization. Therefore, it is “vital that we understand whether device manufacturers and the FDA are taking appropriate steps to keep hazardous devices from the market and to protect patients from marketed devices that are later discovered to be dangerous.”

Transvaginal Mesh Attorney

If you or a loved one experienced transvaginal mesh complications as a result of being implanted with one of the vaginal surgical mesh products, you may be able to file a lawsuit seeking compensation for your medical expenses, pain and suffering, lost wages and more. Bernstein Liebhard LLP has been recognized as a leader in pelvic mesh litigation. Contact us for a free and confidential case evaluation. A pelvic mesh attorney will provide you with personal attention in a sympathetic and caring manner as you navigate the complex litigation process.

Published February 2, 2012 by