The FDA (U.S. Food and Drug Administration) has the authority over regulating and approving implants. The department was established to protect consumers’ health. Over the years there have been high-profile cases, one of which is the legal battle over transvaginal mesh.
In the late 1990s and early 2000s the FDA approved transvaginal mesh implants as a treatment for pelvic organ prolapse (POP) and stress urinary incontinence (SUI). As between 30 and 50 percent of women are at risk of developing prolapse in their lifetimes, the FDA-approved transvaginal mesh implants were used to treat this condition. POP is a condition where there is stretching and weakness of tissues that allows the bladder or other organs to sag or bulge into the vagina causing stress urinary incontinence leading to involuntary leakage. The transvaginal mesh is a medical device which is made from either animal tissue or synthetic materials. The animal-derived mesh is made of processed and disinfected animal tissue whereas the man-made mesh is synthetic plastic (propylene) which is designed to remain in the body indefinitely and is considered a permanent implant, according to WebMD.
There are five companies considered the dominant companies in the market. These companies are Johnson & Johnson, Bard Medical, American Medical Solutions, Boston Scientific and Coolest according to NCBI (National Center for Biotechnology Information – U.S. National Library of Medicine).
Complications from Transvaginal Mesh Implants
Designed to free women from the intimate discomforts of pelvic organ prolapse, once implanted, the hammock-like mesh was meant to shore up the supportive pelvic tissues and help keep sagging organs in place. However, there were complications, according to news media, where some women experienced the material from the implant eroding through the vaginal lining which caused infections, nerve damage, excruciating pain, an inability to sit or urinate without a catheter, and multiple hospitalizations.
Nearly 4,000 complaints of injury, death or malfunction associated with transvaginal mesh surgeries performed between 2005 and 2010 were reported by the FDA in July 2011. In January 2016 the FDA reclassified the devices from “moderate” to “high risk.”
There are nearly 70,000 lawsuits filed by women injured by mesh. These lawsuits are pending in the U.S. District Court for the Southern District of West Virginia. Additional lawsuits are pending in state courts.
Over the years, many other medical devices have received warnings by the FDA which issues Safety Communications. Some of these include the vena cava filter.
Vena Cava Filters (IVC) and Complications
The FDA is concerned about vena cava filters which are small, cage-like devices inserted into the inferior vena cava to capture blood clots and prevent them from reaching the lungs. These filters are frequently placed in patients who are at risk for pulmonary embolisms (blood clots to the lungs). They are designed be to permanent implants. In 2014 the FDA said it received reports of adverse events and product problems associated with the IVC filters. The reports included the migration of the device, filter fracture, movement of the entire filter or fractured fragments going to the heart or lungs, perforation of the IVC and difficulty with removing the device. These problems were in addition to the previously known problems of long-term risks including lower limb deep vein thrombosis. The FDA recommended that physicians remove the IVC filters which were of the retrievable design as soon as protection from pulmonary embolism was no longer needed.
Regulatory Process for Screening Medical Devices
Many medical devices used by physicians are not required to go through the rigorous approval process that drugs face in order to win FDA approval. Medical devices may only need to be cleared through the 510(k) process which only requires that a new device be shown as “substantially equivalent” to a comparable device already on the market.
“Many medical devices over the years have improved the quality of life for thousands of patients. However, when these devices are found to be faulty, they may cause serious injury or even death. If you or a loved one has been injured by a dangerous implanted medical device, contact the team at Spivey Law Firm, Personal Injury Attorneys, P.A.,” said Naples Medical Devices Attorney, Randall Spivey.
Naples Medical Devices Attorney, Randall L. Spivey is a Board Certified Trial Attorney – the highest recognition for competence bestowed by the Florida Bar and a distinction earned by just one (1%) percent of Florida attorneys. He has handled over 2,000 personal injury and wrongful death cases throughout Florida. For a free and confidential consultation to discuss your legal rights, contact the Spivey Law Firm, Personal Injury Attorneys, P.A., in Lee County at 239.337.7483 or toll free at 1.888.477.4839,or by email to Randall@SpiveyLaw.com. Visit SpiveyLaw.com for more information. You can contact Spivey Law Firm, Personal Injury Attorneys, P.A.in Charlotte County at 941.764.7748 and in Collier County 239.793.7748.