As women across the country continue to suffer complications from the use of Johnson & Johnson’s transvaginal mesh devices, a new report reveals that the design of the bladder mesh was based on recalled transvaginal mesh devices that had been taken off the market more than ten years ago due to safety problems. The devices were designed to treat a condition called pelvic organ prolapse.
Transvaginal mesh, also referred to as a pelvic sling or bladder mesh, has been subject to increased scrutiny as the result of problems from its use including:
- Vaginal pain
- Injury to nearby organs
- Bladder perforationsVaginal mesh hardening
If you or someone you love has experienced complications from the use of transvaginal mesh, it is important to speak with an experienced defective medical device attorney who can provide critical advice concerning your injuries. In many circumstances, you may be entitled to monetary compensation.
Here, reports indicate that even though the FDA had pulled a similar mesh design created by Boston Scientific Corporation from the market, the FDA continued approving the similarly designed vaginal mesh created by Johnson & Johnson. Now, makers of the implant face more than 600 lawsuits nationwide from women who have suffered serious injuries from the devices. The devices were approved as part of the FDA’s 510(k) process that allows “fast-track” approval of medical devices where a similar device is already on the market. The fast-track process allows new devices to be approved with little – if any – testing on patients.
The fast-track process has been under fire lately after problems have developed with other medical devices approved through the 510k process such as the defective Depuy Hip System.
A crucial flaw in the process is that where the initial device is recalled, subsequent products based on that design might be missed and allowed to stay on the market.
As New Mexico’s defective medical device attorneys concerned about patient safety, we are hopeful the FDA will revise this process and reduce the risk of serious dangers to the consumers who use these products. For more information or if you have experienced complications from the implanting of the transvaginal mesh or any other defective medical device, contact the dedicated Albuquerque products liability lawyers at the Branch Law Firm to review your claim.