FDA Investigates Claims of Counterfeit Material in Boston Scientific Mesh
The FDA has launched an investigation into allegations that Boston Scientific has used counterfeit materials in manufacturing their mesh products. The investigation comes at a time when the medical device manufacturer is facing thousands of lawsuits involving their mesh devices, filed by women claiming the mesh products left them with serious and sometimes permanent injuries. The FDA has noted there is no indication the counterfeit materials contributed to these adverse effects at this time.
The FDA announcement, which was published on the agency’s website on April 1, states that Boston Scientific will perform additional testing on the counterfeit material to determine its safety and efficacy. The FDA believes that the additional testing will be sufficient to determine whether the counterfeit material is equivalent to the mesh produced using the original raw material. The agency advises the testing will likely take a number of months to complete.
Providers, patients need to know facts about mesh materials
In the meantime, the FDA is recommending that medical providers and patients should educate themselves about the ongoing investigation as they determine the best method of treatment for pelvic organ prolapse (POP) and stress urinary incontinence (SUI). The FDA is not advising women that already have the Boston Scientific mesh to have the device removed at this time.
Boston Scientific is rejecting allegations that they used counterfeit materials in their products, telling news outlets they stand by both their devices and their “robust quality control program.” The company has also stated they are fully cooperating with the FDA and supplying all the information requested by the agency.
Vaginal mesh linked to serious complications
Boston Scientific is one of a number of companies that manufacture vaginal mesh devices to treat conditions caused by the movement of pelvic organs within the abdominal region, including POP and SUI. When they were first introduced to the market, they were touted as a less invasive surgical treatment, minimizing the discomfort and recovery period involved with traditional surgical procedures. However, reports of adverse events concerning these devices have raised questions about their safety and set the stage for thousands of lawsuits filed by women claiming they were unaware of the dangers associated with the mesh products.
Common complaints with these devices include extrusion and erosion of the mesh, leading to pain, bleeding and recurrent infections. Women also complain of painful intercourse after having the mesh implanted. In some cases, the complications have not been reversed, even after surgery to remove the mesh device.
Massive vaginal mesh litigation pending
At this time, more than 20,000 transvaginal mesh lawsuits are pending against Boston Scientific, and thousands more have been filed against American Medical Systems, C.R. Bard, Johnson & Johnson, Cook Medical and other manufacturers. Most of the litigation have been coordinated into a vaginal mesh multidistrict litigation for the purpose of streamlining early trial proceedings for such a large number of similar complaints. The MDLs have mostly been assigned to U.S. District Court for the Southern District of West Virginia, where they are overseen by U.S. District Judge Joseph R. Goodwin.
It remains to be seen whether these new allegations of counterfeit materials will impact the current litigation. However, many women will likely be watching the ongoing investigation with interest to see if these raw materials played a role in their injuries.
- FDA, Urogynecologic Surgical Mesh Implants by Boston Scientific: Notification – Potential for Counterfeit Raw Material, http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm493784.htm
- Bloomberg, FDA Probes Allegations of Counterfeit Boston Scientific Mesh, http://www.bloomberg.com/news/articles/2016-04-01/fda-probes-allegations-of-counterfeit-boston-scientific-mesh
- Boston Globe, FDA to Probe Boston Scientific Implant Allegations, https://www.bostonglobe.com/business/2016/04/01/fda-probe-claims-counterfeit-materials-boston-scientific-implants/y0JSesohwsuC86WO9g0eAK/story.html
- U.S. District Court, Southern District of West Virginia, MDL 2326 Boston Scientific Corp. Pelvic Repair System Products Liability Litigation, http://www.wvsd.uscourts.gov/MDL/boston/
- FDA, Update on Serious Complications Associated with Transvaginal Placement of Surgical Mesh for Pelvic Organ Prolapse: FDA Safety Communication, http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm262435.htm