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.
Apr. 20, 2012: Transvaginal mesh litigation spreads to Canada, as a class action suit alleges that Johnson & Johnson failed to properly warn users about the side effects of the device.
Jun. 4, 2012: Johnson & Johnson subsidiary Ethicon says it will no longer sell the Prolift, Prolift + M, TVT Secur and Prosima transvaginal mesh systems. The products are expected to be completely off the market by the first quarter of 2013.
Jun. 8, 2012: Parker Waichman LLP files a lawsuit on behalf of an Indiana woman who suffered serious injuries, allegedly due to the transvaginal mesh products, including Perigee System with IntePro, Apogee System with IntePro and Mentor Aris Trans-Obturator Tape. The suit was filed in the U.S. District Court for the Southern District of West Virginia, Charleston Division and names American Medical System, Inc., Analytic Biosurgical Solutions, Mentor Corporation, Johnson & Johnson, Ethicon, Inc., Coloplast A/S, Coloplast Corporation, Coloplast Manufacturing and other companies who designed, manufactured or marketed the products as Defendants.
Jun. 8, 2012: Parker Waichman LLP files a lawsuit on behalf of a Kentucky woman who suffered injuries, allegedly due to Boston Scientific’s tranvaginal mesh implant, the Advantage Fit System. The suit was filed in the U.S. District Court for the District of Massachusetts.
Jul. 23, 2012: C.R. Bard loses the first transvaginal mesh personal injury lawsuit. California resident Christine Scott and her husband are awarded a total of $5.5 million dollars for the injuries she suffered after receiving two of Bard’s Avaulta transvaginal mesh to treat her stress urinary incontinence.
Jul. 27, 2012: Parker Waichman LLP files a lawsuit on behalf of a New York woman implanted with the IntePro Large Pore Polypropelene Y-Sling, a transvaginal mesh implant manufactured by American Medical Systems. The suit was filed in the U.S. District Court for the Southern District of West Virginia.
Nov. 9, 2012: Parker Waichman LLP files a lawsuit on behalf of a Colorado woman who was implanted with the TVT transvaginal mesh and alleges that it caused her injuries (Case 2:12-cv-07553). The case was filed into the MDL in the U.S. District Court for the Southern District of West Virginia, Charleston Division as part of the In Re: Ethicon Inc., Pelvic Repair System Products Liability Litigation (MDL No. 2327).