Transvaginal Mesh Sales Halted
The U.S. Food and Drug Administration (FDA) has ordered makers of transvaginal surgical mesh implants to immediately stop the distribution and sale of the products in the United States.
The FDA said that Boston Scientific and Coloplast, the last two companies selling these products in the U.S., have not demonstrated “a reasonable assurance of safety and effectiveness for these devices”.
Transvaginal Mesh Used for Pelvic Organ Prolapse
Transvaginal mesh is used in surgery to repair pelvic organ prolapse (POP) a common medical condition in which the muscles and tissue supporting the pelvic organs (the bladder, uterus, and rectum) become weak or loose. This allows the pelvic organs to press on, into, or out of the vagina. One in eight women will have surgery to repair POP over her lifetime.
History of FDA and Transvaginal Mesh
The FDA approved the first pelvic mesh device for transvaginal repair of POP as a class II moderate-risk device in 2002. Since then, thousands of women and their doctors have filed complaints of injuries resulting from implanted vaginal mesh after POP surgery. The agency issued its first safety communication about pelvic mesh in 2011.
The FDA reclassified vaginal mesh as Class III (high risk) in 2016. As a result of the reclassification, manufacturers were required to obtain premarket approval applications (PMAs), the FDA’s most stringent method of approving medical devices. Some manufacturers voluntarily recalled or discontinued vaginal mesh in the last few years as safety concerns grew.
FDA Ended Sales for Safety of Patients
In reviewing the PMA data submitted by Coloplast and Boston Scientific, the FDA determined that the data didn’t show surgery using mesh was better than surgery using native tissue. Therefore, the benefit of mesh did not outweigh the risk of injury, and the products are not safe to use.
Even though they can no longer sell the devices, Boston Scientific and Coloplast are “required to continue follow-up of the subjects already enrolled in their 522 studies.”
What To Do If You Have Defective Transvaginal Mesh
Any woman who has implanted mesh for POP who is having pain or other complications should contact her doctor immediately. The injuries caused by defective transvaginal mesh include infection, vaginal bleeding or discharge, severe pelvic or groin pain, pain during intercourse, urinary problems, and even organ perforation from implanted mesh eroding into surrounding tissues. Do not delay seeking medical attention if you are in pain.
If you have been injured by a defective transvaginal mesh implant and would like to explore your legal options, call the pelvic mesh lawyers at Thornton Law Firm to talk with Attorney Marilyn McGoldrick. You can also tell us your story online for a confidential, free evaluation of your legal rights.
If you have suffered injury caused by a defective drug or medical device, call 888-341-1405 for a no-obligation evaluation of your legal rights, or tell us your story using our online contact form.
Boston Scientific has recalled the RotaWire Elite Guidewire and wireClip Torquer Guidewire components of its Rotablator Rotational Atherectomy System. The company received three reports of wires fracturing, one during preparation of the device, and two during actual surgeries. The fractures during surgery resulted in migration of the wire, puncturing the pericardium surrounding the heart. One patient died during surgery to remove the broken wire.
The Rotabator Rotational Atherectomy System is used to surgically remove atherosclerosis from arteries. The device uses a tiny burr rotating at high speed to remove plaque and improve blood flow to the heart. The tip of the device rotates at 190,000 rotations per minute during the procedure.
The recall covers 955 devices distributed in the following states: Arizona (AZ), California (CA), Delaware (DE), Florida (FL), Georgia (GA), Illinois (IL), Louisiana (LA), Maryland (MD), Mississippi (MI), Minnesota (MN), Nebraska (NE), New York (NY), Pennsylvania (PY), South Carolina (SC), Texas (TX), Washington (WA), and Wisconsin (WI). The recalled devices were manufactured from June 26, 2015 to Sept. 10, 2015 and distributed from July 9, 2015 to Oct. 1, 2015.
Boston Scientific sent hospitals an Urgent Medical Device Recall letter in October of 2015 asking them to stop using the device immediately. The FDA announced the Class 1 recall of the device in November.
If you believe you suffered injuries as a result of a faulty Boston Scientific guidewire, contact the Boston law firm of Thornton Law Firm LLP online or at 1-888-341-1405 for a free consultation with a recognized leader in Massachusetts drug and medical device litigation. You have nothing to risk. We offer a fair and accurate assessment of your case.
A Delaware jury awarded $100 million dollars to a woman who suffered vaginal scarring and constant pain after receiving transvaginal mesh implants made by Boston Scientific. The Delaware state court jury awarded $25 million in compensatory damages and $75 million in punitive damages to Deborah Barba, age 51. Mrs. Barba was implanted with Boston Scientific’s Advantage Fit and Pinnacle transvaginal mesh (TVM) products in 2009 to treat to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI). Thousands of women have been implanted with similar mesh products to treat POP and SUI over the last decade. Thornton Law Firm represents women across the United States in lawsuits against various pelvic mesh manufacturers for the serious injuries those implants have caused.
The jury found that the mesh implants were defectively designed and manufactured, and that Marlborough, Massachusetts-based Boston Scientific failed to warn doctors and patients of the risks. Mrs. Barba suffered vaginal scarring, mesh erosion and constant, unremitting pain that left her unable to have sexual intercourse. Despite two subsequent surgeries, doctors have not been able to remove all the embedded, pain-causing mesh. After the verdict was announced, she spoke out for other women suffering from defective transvaginal mesh: “I am thankful for the jury’s verdict and hope my story can help other women who are suffering from mesh complications to receive the resolution they deserve. While difficult to share, I hope my case demonstrates to all mesh manufacturers the dangers of their products and the justice they owe victims.”
This is the largest verdict against any manufacturer in the mesh litigation. The largest verdict before this was $73.5 million awarded last year to a Texas woman against Boston Scientific over her Obtryx mesh sling. More than 70,000 mesh cases are pending in federal court in West Virginia, and more are pending in state courts in California, Delaware, Missouri, New Jersey, and Texas.
Thornton Law Firm’s transvaginal mesh attorneys represent women in claims against all the manufacturers of transvaginal mesh: Boston Scientific Corp., Caldera, C.R. Bard, Inc., Ethicon (a subsidiary of Johnson & Johnson) and Sofradim/Covidien. If you have a transvaginal mesh implant and have suffered complications including mesh erosion, mesh contraction, pain, additional surgery, infection, bleeding, urinary problems, vaginal tightening or shortening, painful sexual intercourse, inability to engage in sexual intercourse, or organ perforation, for a free, confidential evaluation of your legal claim, please tell us your story here or call our toll free number 888-341-1405. Like all legal claims, defective mesh claims are subject to short, strictly enforced time limits. Do not delay seeking legal advice.