“Stating that vaginal mesh is harmful to patients, House Democrats called for congressional hearings on vaginal mesh products made by Johnson & Johnson.
Rep. Henry Waxman, (D-Cali.), and three colleagues urged Republican leaders of the House Energy and Commerce Committee to hold a hearing and demand documents from manufacturers. This is critical as Congress considers re-vamping the approval process the Food and Drug Administration (FDA) uses to approve medical devices..
Last month, the FDA ordered Johnson & Johnson and 32 other transvaginal mesh manufacturers to perform safety studies, citing reports of internal injuries and complications with the device.
“”We need to understand the safety of devices on the market, the tactics device manufacturers and others use to market these devices, and the extent to which these tactics may increase risks,”” said Democrats in a letter to Republicans. Mathew Johnson, spokesman for Johnson & Johnson, did not comment..
The FDA’s medical device approval process, or 501(k) process, where medical devices can get approval without human testing is another concern.. All a medical device manufacturer has to do in order to get their product approved for sale is to show that the device is significantly similar to others already on the market. This is exactly what happened with vaginal mesh. The original product was approved by a strict approval process, then, other mesh products came out and were approved because the FDA had approved the original even though the original was linked to complications and later removed from market.
Many vaginal mesh products have several complications associated with them, including pain, painful urination, bleeding, infection, painful sexual intercourse, and mesh shrinkage. One of the most commonly reported complications, according to a report released in July 2011 by the FDA, is mesh erosion where the mesh erodes into surrounding tissues.
Many women have to undergo several corrective surgeries, and these products are very difficult to remove as they are designed to grow around human tissue.
The FDA warned health care professionals about the device, in 2008.. The agency wanted surgeons to receive specialized training to learn how to properly implant the device and warn their patients of any dangers associated with it that the agency deemed as rare, but serious.
Since a formal warning issued by the FDA in July 2011, more 650 lawsuits have been filed accrues the country by women who allege they have been harmed by the device.”