FDA Recalls the Pinnacle Transvaginal Mesh System, Manufactured by Boston Scientific Corp.
Online PR News – 26-August-2011 – – According to Ennis & Ennis, P.A., on August 3, 2011 the US Food and Drug Administration (FDA) recalled the Pinnacle Pelvic Floor Repair Kit manufactured by Boston Scientific Corporation (BSC). (www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?ID=100416" target="_blank" class="highlight_link">http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?ID=100416) The Pinnacle device is made of the synthetic material, polypropylene, and is implanted transvaginally to treat pelvic organ prolapse (POP) stress urinary incontinence (SUI). The mesh device includes legs that are fastened into ligaments to provide vaginal support. This kit utilized Boston Scientific’s Capio Suture Capturing Device, which provided a minimally-invasive approach to implantation of the mesh device. Unfortunately, according to the FDA’s notice, this recall was prompted after complaints that “the device may exhibit low tensile strength between the needle and the suture and lead to needle detachment during the mesh leg placement.” There were 540 of these devices in commerce worldwide and BSC was to send notices to all affected customers.
Although this recall is specific to needle detachment, Boston Scientific has also been the subject of recent lawsuits where plaintiffs allege BSC’s defective vaginal mesh products cause injuries such as vaginal mesh erosion, mesh migration, formation of scar tissue and granuloma formation. BSC, which is headquartered in Massachusetts, is just one of several companies that has been named in transvaginal mesh lawsuits over the past several years. Last October, C.R. Bard’s Avaulta mesh was consolidated as part of a multidistrict litigation for pretrial proceedings in the US District Court for the Southern District of West Virginia. Additionally, as of last month, more than 400 people had filed claims in NJ state court against Ethicon, Inc. and Johnson & Johnson as a result of the injuries associated with their Gynecare mesh products.
While the FDA initially approved of transvaginal mesh devices to treat POP and SUI, they issued an advisory on July 13, 2011 reporting that there is little evidence that the mesh implants improve these conditions and that the devices actually expose the patients to a number of risks and complications that are not rare.
On September 8-9, 2011, the Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee will meet to make recommendations regarding how to proceed. In the meantime, Attorney Holly Ennis recommends that all patients with symptoms first seek medical attention. Then they should report the incident to the FDA by filing a voluntary report at https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm. Lastly, patients should seek the opinion of an experienced lawyer to explore their legal rights.
Ennis & Ennis is offering free nationwide confidential consultations to all women who have a transvaginal mesh implant by calling toll free 1-800-856-6405 or by going to www.ennislaw.com and completing an online case evaluation form.
Ennis & Ennis, P.A. is a nationwide law firm with offices in Ft. Lauderdale, Miami and Washington D.C. Ennis & Ennis, P.A. specializes in mass torts and represents individuals against pharmaceutical companies worldwide as well as medical device makers.
Ennis & Ennis, P.A. has been representing clients individually since 1986 and has recovered over $100 million in settlements for its clients.
Ennis & Ennis, P.A. is also investigating cases involving, Accutane, Actos, Avandia, Fosamax, Paxil, Zoloft, Prozac, Depuy Hip Recall, Zimmer Hip Recall, Depakote, Reglan, SJS/Dilantin, Yaz, Yasmin and Ocella Birth Control Pills.
Remember the law limits the time in which you can file a claim so don't wait to explore your legal rights. Call today toll free 1-800-856-6405 or visit www.ennislaw.com.