No Product ID, No Case
Stephanie Gease of Johnstown, Pennsylvania was unaware her doctor had implanted mesh when performing her 2016 hysterectomy, as Law360 reported. Gease learned about the mesh implant when a different doctor found it while operating to correct Gease’s bowel and kidney problems, which she later attributed to the mesh implant.
Transvaginal mesh is a type of medical netting made from polypropylene, Gore-Tex, or other materials. At one point, 32 companies manufactured transvaginal surgical mesh for use in women’s health surgeries such as procedures to correct incontinence or pelvic organ prolapse. Most former manufacturers withdrew their mesh from the market years ago in response to the FDA’s 2011 orders that manufacturers begin conducting three-year patient follow-up studies.
U.S. District Judge William Stickman IV dismissed Gease’s case when she couldn’t provide specific details about the model, lot number and manufacturer of the mesh implanted inside her. Stickman said that Gease’s right to sue didn’t exist under state product liability law because she couldn’t “identify the product and manufacturer of the product that caused her injury.”
Gease told the court she believed the mesh was made by Ethicon Inc. or Boston Scientific, but the judge said she’d “failed to identify the specific brand of mesh at issue.”
Staying Informed About Your Medical Device is Essential
Knowing the product’s UDI, the exact type of mesh and what it’s made of is essential for patients with device-related medical problems.
With a UDI, patients can track product recalls through new apps like TrackMy Implant. Using this platform, patients who don't have their UDI can get help accessing it. Other platforms like Device Events also rely on the UDI to find whether a patient's device has been recalled.
“That’s why it's important to get product IDs and know the materials of the device, whether it’s metals, polypropylene, and so forth,” Madris Tomes, former FDA program manager for unique device identification and currently CEO of Device Events, said.
An FDA spokeswoman told MedTruth that the UDI is supposed to appear on the “labels and packages of implantable devices manufactured and labeled after September 24, 2015.”
As reported by Jay Crowley, the senior advisor for patient safety in the FDA’s Center for Devices and Radiological Health, in the year 2007, the FDA received about 66,000 adverse events reports. Fifteen percent of those reports lacked model or catalog number, whereas 50% lacked lot or other identifiers. Ten percent lacked both.
That same year, there were 41 Class I recalls, 931 Class II recalls and 78 Class III recalls. Those recalled devices had been implanted in millions of people.
The need for improved identification and reporting methods was evident. In September 2007, the unique device identifier system was officially proposed and passed into law.
The Secretary shall promulgate regulations establishing a unique device identification system for medical devices requiring the label of devices to bear a unique identifier, unless the Secretary requires an alternative placement or provides an exception for a particular device or type of device. The unique identifier shall adequately identify the device through distribution and use, and may include information on the lot or serial number.
Since then, the FDA has been working to implement UDI requirements across all devices.
UDI requirement compliance dates are as follows:
Must bear a UDI
Class III devices, Devices licensed under the PHS Act
Implantable, life-supporting and life-sustaining (I/LS/LS) devices
Class II devices
Class I devices, Devices not classified class I, II or III
Tomes cautioned, however, that the FDA requirement doesn’t mean that all physicians and hospitals are currently logging UDIs into patient medical records or consistently providing that information to patients.
“I don’t think physicians and hospitals are using it yet, not regularly,” Tomes told MedTruth. “Smaller hospitals had no clue what I was talking about when I asked for the UDI.”
However, change is on the horizon. Electronic health records are being updated to include UDIs, although a full rollout is still “a ways off for most hospitals," Tomes said.
In the meantime, patients need to ask for their medical device’s UDI and may even need to explain what that is, she said.
The Back Story: Mesh Was Approved Via FDA Loophole
Gease's case underscores more than the issue of limited access to necessary medical device identifiers. It also calls attention to an approval system that is not designed to ensure the safety of each specific device sold on the market.
The FDA approved mesh kits for transvaginal prolapse repair in 2001 as a class II medical device — an approval classification that doesn’t require independent clinical research or a scientific review. Due to a loophole in the approval process for medical devices that are considered similar to existing medical products already on the market, the FDA did not require studies on the mesh kits. The administration, instead, determined that vaginal mesh was similar to mesh used for abdominal hernia repair — and gave vaginal mesh the greenlight.
Surgeons began implanting transvaginal mesh in thousands of women. Between 2005 and 2008, the FDA received more than 1,000 reports of complications from nine surgical mesh manufacturers.
The leading side effect of surgical treatment with mesh is mesh erosion, which occurs when the product migrates from its initial location. According to data from 110 studies of nearly 12,000 women who had mesh implanted during pelvic organ prolapse surgery, about one in 10 women experienced mesh erosion inside a year.
In October 2008, the FDA issued a Public Health Notification warning of “rare” but serious mesh-related complications. Over the next three years, the FDA received an additional 2,874 Medical Device Reports related to transvaginal surgical meshes, including reports of injuries and death.
Then, in 2011, the FDA released an update acknowledging that “the risks of serious complications associated with transvaginal POP (pelvic organ prolapse) repair with mesh are NOT rare” and that “transvaginally placed mesh in POP repair does NOT conclusively improve clinical outcomes over traditional non-mesh repair.”
Although the FDA “encouraged” doctors to weigh the risks of mesh before using the product in patients in the 2011 update, the agency also shifted some of the onus to patients. The administration advised consumers to arm themselves with information about the safety of mesh devices and ask their surgeons specific questions regarding mesh, including about complications and alternatives.
Tomes suggested that clinicians and manufacturers should instead be tasked with proactively disclosing safety risks.
“Certainly it should be on the providers and the device manufacturers to provide better information."...“The FDA needs to step in and get stricter about informed consent and what needs to be contained in informed consent.”
“We Couldn’t Assure Women That These Devices Were Safe,” FDA Said.
The FDA, however, has taken years to crack down on mesh.
In 2016, the agency upgraded mesh to a class III device, its strictest approval level. The reclassification forced manufacturers to meet higher safety standards to keep their products on the market in the U.S. Most manufacturers, except for Boston Scientific and Coloplast, stopped selling the product.
Three years later, in April 2019, the FDA pulled transvaginal mesh from the market, warning that the safety risks outweighed the product’s benefits.
“We couldn't assure women that these devices were safe and effective long term,” said Dr. Jeffrey Shuren, director of the FDA's Center for Devices and Radiological Health, said in the agency’s April press announcement.
Meanwhile countless women like Gease who believe mesh caused significant health complications are forced to continue searching for their medical device UDI — although their electronic health records might not contain that information.
This issue might have implications beyond urovaginal mesh, Tomes said, because the FDA hasn’t addressed other types of mesh such as hernia mesh and mesh for stress urinary incontinence, which appear to carry similar risks.
Those products remain on the market.