A bill introduced by House Democrats this month, if passed, will allow federal regulators to block medical devices tied to safety recalls such as the transvaginal mesh implants that are manufactured by companies including C.R. Bard Inc. and Johnson & Johnson. According to a Bloomberg news report, the bill would close a loophole that allows medical devices to get the stamp of approval from the U.S. Food and Drug Administration (FDA) even when they are similar to an unsafe product that has been already pulled from the market.

Vaginal mesh implants spurred an FDA alert in 2011 after thousands of patients complained of pain and internal injuries. A number of these defective products received approval through the FDA’s 510 (k) system, which basically allows devices to be sold without human testing as long as the federal agency finds them to be similar to other existing products. Most vaginal mesh implants can trace their approvals to a Boston Scientific Corp. mesh. The approvals were given for subsequent products although the original mesh products made by Boston Scientific were recalled for safety issues in 1999. This bill, however, has a long way to go. It must pass the Republican-controlled House and Democrat-led Senate, and be signed off by President Obama.

Necessary Legislation

Although medical device manufacturers will fight this bill tooth and nail, it is an important piece of legislation for consumers. Current law requires the FDA to clear a device for sale it is “substantially equivalent” to a past device. The bill will give the FDA the power to say “no” if the devices were removed from the market. The FDA will also have the authority to ask manufacturers to explain why their products are different from the recalled versions.

Serious Side Effects

The pain that the defective vaginal mesh implants are causing to thousands of women nationwide alone should be sufficient reason to get this law passed. A number of vaginal mesh products being sold including those made by C.R. Bard and Johnson & Johnson were not properly tested before they were put on the market. They received the FDA’s approval anyway, thanks to the flawed 510 (k) system. About 300,000 women a year receive these implants to help shore up pelvic muscles or to treat incontinence. In January, the FDA ordered more safety studies from manufacturers.

Justice for Victims

Three of the vaginal mesh cases handled by the Orange County personal injury law firm of BISNAR CHASE are against C.R. Bard for its Bard Avaulta System. The women we represent suffer from a variety of complications related to the mesh implants including infection, erosion of the implant into the vagina, urinary problems, sever pain, depression, and bowel and bladder perforations. Two of these victims underwent surgery to try and fix these painful problems.

These are some of the more alarming defective product cases we have seen in many years. This is an issue that seriously affects the victims’ quality of life. Women are unable to be intimate with their partners. They suffer from serious psychological issues including depression. Given the high number and the severity of these cases, it is about time, our lawmakers took action to ensure that such dangerous and defective products do not make it to the marketplace.