Transvaginal mesh implants are intended to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI); pelvic organ prolapse is when the pelvic muscles slide out of place and into the vagina and stress urinary incontinence is the involuntary release of urine.
These conditions, which become more common after childbirth, are typically caused by the weakening of the pelvic walls and muscles.
Transvaginal mesh is supposed to correct these conditions by providing additional support to the pelvic walls, but recent lawsuits allege that these devices only cause more issues. To find out more about patient compensation for transvaginal mesh injuries, contact one of our experienced medical device attorneys today.
See below for a comprehensive timeline that includes a history of transvaginal mesh, important dates, device recalls, and updates on the lawsuits and settlements.
Transvaginal Mesh Timeline
Nov. 15, 1996: The Food and Drug Administration (FDA) gives Boston Scientific clearance for ProteGen through the 510(k) route, a process that allows devices onto the market without a substantial amount of clinical testing as long as the manufacturer can argue that it is similar enough to a previous device, referred to as a predicate. Boston Scientific’s evidence was based on 3 month rat study, and cited predicates such as hernia slings and fabric used for cardiac surgery. The ProteGen is the first transvaginal mesh device targeted to treat incontinence.
Jun. 1998: The FDA inspects a Boston Scientific manufacturing plant and finds that problems with the device are worse than reported, failing to cite certain cases of serious medical complications. The agency stated, “”During the inspection, it was learned that the number of events being reported is approximately two-thirds of the complaints being made to the firm,” according to The Star Ledger.
Aug. 18, 1998: Despite the results of the previous inspection, there is no solid reason for Boston Scientific to issue a recall, the FDA says in an investigation report.
1998: Johnson & Johnson wins clearance for Gynecare TVT through the 510(k) route, citing Boston Scientific’s ProteGen as a predicate.
Jan. 22, 1999: Boston Scientific recalls the ProteGen, stating that the device “does not produce outcomes that are consistent with the company’s standard of performance for its products or customer expectations.” cites The Star Ledger. Reportedly, the company received complaints of pain during sexual intercourse, discomfort and vaginal tissue erosion. Despite the acknowledged failure, the recall does not affect J&J’s Gynecare TVT device, nor any following devices based on either of these products.
2003: Boston Scientific settles 738 lawsuits over its vaginal mesh device. The amount is undisclosed.
2005-2007: The FDA receives over 1,000 reports from nine different manufacturers citing frequent complaints such as erosion of vaginal tissue, pain, infection, urinary problems, and recurrence of Pelvic Organ Prolapse (POP) and Stress Urinary Incontinence (SUI), the original problems that were supposed to be treated. Reports also included instances of bowel, bladder and blood vessel perforation during the initial procedure.
Oct. 20, 2008: The FDA issues a Public Health Notification warning about the serious complications related to transvaginal mesh implants used to treat SUI and POP, citing the numerous reports received from 2005-2007. At this time, the agency says that the complications are rare, but potentially serious.
Jan. 1, 2008- Dec. 31, 2010: The FDA receives 2,874 additional reports concerning the complications associated with the mesh implants used to treat POP and SUI. Common complaints included vaginal erosion, pain, infection, bleeding, painful sexual intercourse, urinary problems organ perforation. Reports also included cases of emotional problems, vaginal scarring and shrinkage, neuromuscular difficulties and recurrence of POP symptoms.
2010: An FDA-estimated 300,000 women receive transvaginal mesh implants.
Jul. 13, 2011: The FDA releases an update on its previous Public Health Notification regarding the safety risks associated with vaginal mesh implants. The update cites the reports received between 2008-2010, stating that the complications are in fact not rare, as previously announced in 2008. The update also notes that “it is not clear that transvaginal POP repair with mesh is more effective than traditional non-mesh repair in all patients with POP and it may expose patients to greater risk.”
Sept. 2011: An FDA advisory panel recommends that vaginal mesh implants used to treat POP should be reclassified from moderate-risk to high-risk. The reclassification would force manufacturers to conduct studies based on human testing.
Jan. 2012: The FDA orders 33 manufacturers, including J&J and C.R. Bard, to conduct 3 year studies to assess the impact of transvaginal mesh implants on organ damage and other serious complications.
Jan. 2012: Industry manufacturers are faced with over 650 lawsuits alleging that the device caused a host of painful injuries.
Feb. 7, 2012: The U.S. Judicial Panel consolidates three multidistrict litigation (MDL) cases into one. Lawsuits filed again J&J’s Ethicon Inc., American Medical Systems and Boston Scientific are set to be centralized before U.S. District Chief Judge Joseph R. Goodwin in the Southern District of West Virginia.
Transvaginal Mesh Complication Victims – Legal Help
If you or a loved one suffered painful injuries as a result of POP or SUI repair that involved a vaginal mesh implant, you may have valuable legal rights. To learn more about obtaining compensation for transvaginal mesh injuries, please fill out our online form, or call 1-800-YOURLAWYER (1-800-968-7529).
http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm262435.htm – See more at: /topics/overview/transvaginal-mesh-timeline#sthash.uUS2WomZ.dpuf