Published on Feb 19, 2025
The information contained in this report is compiled from the FDA’s Manufacturer and User Facility Device Experience (MAUDE) database. The MAUDE database contains reports of deaths, injuries, and malfunctions relating to the use of medical devices and is updated monthly with reports from users, physicians, and device manufacturers. The FDA uses MAUDE reports to monitor device performance and spot potential device related issues but the agency cautions that the sheer number of reports should not be used in isolation to determine the existence or severity of device problems. The Capitol Forum’s full monthly analysis of the MAUDE data can be found here.
At home dental aligner company Byte, a subsidiary of Dentsply Sirona (XRAY), is continuing to report a high backlog of injuries and malfunctions to the FDA, over three months after Denstply Sirona pulled the product from the market and one month after it officially shuttered the subsidiary.
According to a Capitol Forum analysis of the FDA’s Manufacturer and User Facility Device Experience (MAUDE) database, Byte reported 1,320 injuries and malfunctions relating to the use of its aligners in January. Roughly 42% of those reports were made within the required 30-day reporting period; as The Capitol Forum previously reported, Byte had no effective process for reporting injuries to the FDA and the company has recently been reporting thousands of injuries that are several years old.
At issue with Byte’s aligners was the fact that most consumers were receiving orthodontic treatment without any ongoing supervision from an orthodontist or dentist, leading to severe injuries including cracked teeth, lost teeth, and severe jaw pain. When Dentsply Sirona pulled Byte products from the market, the company required any patients currently undergoing treatment to see a dentist in order to continue with their treatment plans.
Details from the most recent batch of medical device reports (MDR) indicate that those dentists are increasingly advising patients to stop Byte treatments altogether. According to a Capitol Forum analysis of the MAUDE database, 10% of all reports submitted in January indicated language indicating that dentists had recommended Byte patients to discontinue their treatment.
Those dentists are similarly finding severe injuries caused by Byte’s aligners that will take additional work to correct. “The patient reported dentist recommended to stop treatment due to occlusion and periodontal disease,” one report from January reads.
Dentsply Sirona declined to comment for this article.
Mentor breast implant injuries trend upward. Injuries and malfunctions of non-inflatable breast implants produced by the company Mentor, a subsidiary of Johnson & Johnson (JNJ), have increased over the last several months, according to The Capitol Forum’s analysis of the MAUDE database.
In January, the company reported 609 new events involving the Mentor breast implants, a significant increase over the company’s typical number of monthly reports: The increase in Mentor MDRs can partly be attributed to an uptick in reports of material ruptures. According to The Capitol Forum’s analysis, in January Mentor reported 293 incidents where the implant ruptured while in a patient, resulting in the removal and replacement of the implant:
The FDA has recently been paying attention to MDRs relating to breast implants. Earlier this month, the FDA released a report analyzing trends in breast implant MDRs and the frequency of a condition known as Breast Implant Illness.
Johnson & Johnson did not respond to questions regarding the uptick in Mentor breast implant ruptures.
Procept Biorobotics bleeding injuries increase. Patient bleeding injuries from the use of Procept Biorobotics’ (PRCT) Aquabeam increased over the last several months, with the company reporting 16 cases of patient hemorrhages in December and January. The Aquabeam robot uses high-pressure water to remove excessive prostate tissue in a novel procedure known as Aquablation.
As The Capitol Forum has previously reported, some urologists have questioned the need for Aquablation to treat enlarged prostates, given its limited use cases and existence of cheaper and more well-established procedures like transurethral resection of the prostate (TURP). Moreover, Aquablation carries a higher risk of bleeding, which is often addressed by performing a second TURP procedure, essentially meaning doctors are performing two similar procedures for the price of one.
“Aquablation definitely has advantages for larger prostates, but the caveat to Aquablation is that you have Aquablation for removing porstate tissue and a competing technology, typically TURP, to address hemostasis,” Dr. Bilal Chughtai, a professor of urology at Weill Cornell Medicine told The Capitol Forum in 2022.
A Capitol Forum analysis of the MAUDE database finds that the reports of patient hemorrhages resulting from the Aquablation procedure have been increasing over the last several months.
The increase in reports of patient hemorrhages, which has roughly doubled over the past year, has outpaced the growth of Aquablation’s share in the industry. On the company’s most recent earnings call in October, CFO Kevin Waters told investors that utilization of the Aquabeam was low to flat compared with the third quarter of 2023 as the company took sales representatives out of the field to train them on its newer HYDROS robot.
While it is unclear what has caused the uptick in reports of hemorrhages among Aquablation patients, a former sales employee at Procept told The Capitol Forum that, in their opinion, Procept did not provide urologists with the necessary training, increasing the risk of complications during surgeries.
“Procept’s big problem is a lack of investment and focus on clinician training prior to adoption,” the former employee said. “Aquablation’s mechanism of action is novel and urologists aren’t used to seeing the prostate tissue in that state after treatment, which can lead to missing transected vasculature and bleeding post-operatively.”
According to the former employee, a potential explanation for the spike in adverse events in January is the fact that a large number of accounts purchase new systems in December and those new users complete their first procedures in January. However, “from the company’s perspective, the time commitment, investment and focus on clinical education is at odds with hitting install base and utilization growth targets.”
Procept did not respond to questions regarding the uptick in patient bleeding.
Data indicates recall-related issue in Medtronic devices outside recall scope. Of 550 adverse events involving Medtronic-manufactured implantable cardiac rhythm devices, the January data contained just two in which triggering of a short-circuit protection feature was identified.
The implantable cardiac defibrillators were recalled in 2023 due to concerns that inappropriate activation of the short circuit protection feature could cause the devices to deliver low or no energy output, failing to correct a life-threatening arrhythmia. The recall, which was classified by the FDA as its most serious type, did not necessitate the removal of the devices from the market; instead, Medtronic continued to sell the devices but distributed a software update for device management that it said would resolve the problem.
The recall applied to all devices manufactured after July 2017. Both events reported in January involved devices that were manufactured prior to July 2017, putting them outside the scope of the recall. The events were each classified as injuries.
The Capitol Forum has previously reported about the prevalence of recall-related issues appearing in devices outside the recall scope.
