As recently as 2008, the FDA had defined bladder sling mesh complications symptoms as serious, but rare. As the number of mesh bladder sling lawsuit claims against several mesh manufacturers grows, more attention is being drawn to the injuries suffered by thousands of women. Vaginal pain, bleeding, urinary problems, and erosion of the mesh through the wall of the vagina have caused significant suffering among implant recipients. But the magnitude of these problems was relatively unknown until a few years ago.
Incidence of pelvic mesh failure, along with the failure of other medical devices, has become so common that Consumer Reports recently released a highly-critical article about the topic. Although the piece is not scheduled for release until the magazine’s May 2012 issue, it is already available online. It is likely to spur additional vaginal mesh lawsuit claims against Johnson & Johnson, C.R. Bard, and other mesh manufacturers. Below, we’ll highlight some of the most salient points in the article.
The FDA’s 510(k) Premarket Notification System
Consumer Reports was particularly critical of the FDA’s current system for approving mesh products and various other Class II (moderate risk) medical devices. Known as 510(k) premarket notification, this system allows manufacturers to submit some of their implants without first subjecting them to rigorous clinical trials. Instead, the companies can gain approval for their devices by demonstrating they are similar to others that are already approved for sale. This is known as “substantial equivalence,” or as Consumer Reports referred to it, “a loophole in the law.”
One of the problems with the 510(k) approval process is that mesh products may be approved based on their similarity to devices that are later proven to be defective. This is precisely what occurred with Johnson & Johnson’s Gynecare TVT, a bladder sling used to correct stress urinary incontinence. The implant was approved by the FDA based on its substantial equivalence to Boston Scientific’s ProteGen Sling. The ProteGen Sling was then recalled in 1999 due to thousands of reports of complications. Meanwhile, the Gynecare TVT remains on the market.
Consumer Reports is right to point blame at the FDA’s lax approval process. To that end, the agency is revisiting its Class II designation for mesh implants to assess whether the devices should be recategorized as higher-risk Class III products. But this doesn’t excuse mesh manufacturers from their failure to protect the public’s safety.
Mesh Manufacturers Still Responsible For Patients’ Safety
Companies that sell medical devices are expected to meet several standards, not merely related to the quality of their products, but also in their responsibility to patient safety. For example, manufacturers are expected to conduct post-market studies to track the efficacy and safety of their implants. They are also expected to inform the public about the risks associated with them.
The sheer number of transvaginal mesh injuries reported by women indicates these and other standards were not met by some manufacturers. Moreover, the fact that few companies have proactively issued a vaginal mesh recall for their products suggests such standards are not a top priority.
Mesh Bladder Sling Complications Highlight Manufacturers’ Failures
The injuries suffered by women are as diverse as they are serious. In addition to vaginal pain, bleeding, and urinary dysfunction, many women have suffered from recurring infections. Some have also experienced contraction of the mesh implant, resulting in vaginal shortening and tightening. This can cause debilitating pain that is aggravated by simple movement. Others have described permanent nerve damage.
Women have also reported suffering from bowel and bladder perforations that occurred during the surgical procedure to install the implants. In the report, “Urogynecologic Surgical Mesh: Update on the Safety and Effectiveness of Transvaginal Placement for Pelvic Organ Prolapse,” the FDA noted that two women have died from organ perforations.
Erosion of the device has been the most consistently-reported complication; the mesh starts to move through the vaginal tissue. Although the solution is to remove the defective implant, doing so is not always possible, even after multiple surgeries. Unfortunately, this means some women are forced to cope with ongoing pain and discomfort.
The Consumer Reports article will prove to be eye-opening for many women who are unaware their mesh implants are associated with such serious injuries. If you underwent vaginal mesh surgery, and developed complications afterward, consult a mesh bladder sling lawsuit lawyer. You may be eligible to file a claim for compensation from the manufacturer.