Medical device safety in spotlight after high profile recalls

Lawmakers and patients have called for scrutiny of the Food and Drug Administration's medical device recall oversight after several high-profile recalls in the last five years. The U.S. Government Accountability Office said in January 2024 it would look into the agency’s oversight of medical device recalls, a little over a decade after a previous investigation by the watchdog found the FDA often failed to conduct recall-related inspections and document why a recall was terminated. 

Safety problems with devices have gotten lawmakers’ attention again. Philips is still resolving a recall of more than 15 million sleep apnea machines and ventilators due to health risks from soundproofing foam breaking down, and the company recently halted sales of the devices in the U.S. Problems with inaccurate readings from pulse oximeters have also garnered scrutiny, with some agency advisors calling for faulty products to be recalled. 

MedTech Dive interviewed product and patient safety experts about what changes the FDA can make to improve the recall process. Here are six recommendations:  

1. Improve tracking of adverse events

Adverse event reports are important for informing the FDA’s oversight of recalls. Manufacturers are required to submit reports of serious injuries, deaths or device malfunctions that could cause a health risk to the FDA. Hospitals, ambulatory surgical centers and nursing homes must also submit reports of suspected medical-device-related deaths. 

This process has two problems: manufacturers may delay sending reports to the FDA, and physician offices, where certain procedures may be done, are not required to report problems with devices, said Madris Kinard, a former FDA analyst who built software called Device Events to track adverse events and recalls. 

Before Philips’ recall of respiratory devices, an FDA inspection found the company held thousands of reports of problems with its sleep apnea machines and ventilators. Manufacturers are required to submit these reports within 30 days, or as quickly as five days when the risk of harm to the public is “substantial,” but Philips was years late in submitting several reports, according to a Propublica article. 

“They found so many complaints that hadn't been submitted to the FDA, and then of course, they just flood in after that inspection,” Kinard said. “With [continuous positive airway pressure machines], it got a lot of attention, so the reports came in. We'll see that with other devices, and then we're waiting and don't see the reports come in.”

Bayer’s Essure device, which was pulled from the U.S. market in 2019, also had thousands of complaints that were not reported to the FDA in a timely fashion, according to the International Consortium of Investigative Journalists. 

One solution could be adding a liaison position where if a site doesn't meet quality standards in an inspection, someone is assigned to go between the inspection and the FDA to make sure things get resolved, Kinard said.

“Otherwise, they just wait, go out for another inspection in two, three years and see the same things again,” she added.

Kinard also noted that even if a problem is thought to be caused by user error, it still needs to be reported to the FDA. Maybe the instructions need to be updated or there is a problem with the device. For example, after the FDA flagged a growing number of adverse events related to surgical staplers in 2019, Medtronic recalled millions of staplers that were missing a pin.  

Physician offices should also be counted under the user facilities that are required to submit medical device reports to the FDA, Kinard said. Breast implants are often removed in a physician's office instead of a hospital, so reports of problems with the devices might not be sent to regulators. Even if physicians are reporting information to an implant registry, most registries don’t report regularly to the FDA, Kinard said.  

FDA spokesperson Kristina Wieghmink wrote in an email that medical device reports are used to monitor device performance, detect potential safety issues and contribute to the benefit-risk assessment of products.

She confirmed that while the FDA generally requires manufacturers to submit reports within 30 days, there are instances where the agency may grant an exemption or variance.

“The FDA will investigate potential violations of the applicable laws and take action as appropriate,” Wieghmink wrote. 

 

2. Require electronic recall notifications

At the start of a recall, manufacturers often mail out notifications to hospitals in overnight envelopes, even though the FDA has issued guidance encouraging the use of electronic communications. Relying on paper notices alone can slow the process down as mail is routed through hospitals and as manufacturers await a mailed acknowledgment back, said Guillermo Ramas, CEO of Notisphere, a company that makes software to manage medical recalls. 

It can take about two weeks between when a recall is issued and when a recall coordinator at a hospital knows about it via paper, Ramas said. Hospitals then have to manually input the recall information into their internal databases. The process can repeat itself if a device company doesn't receive enough acknowledgments back from hospitals. 

“You're now six months into a recall where there's very little visibility into is everybody aware of the recall? Is every hospital pulling items from the shelves and stopping the use of them?” Ramas said. 

Despite the FDA’s guidance, many manufacturers still use paper communications. 

“There's a little bit of a disconnect there,” Ramas said. “I've had suppliers straight up tell me, ‘No, the FDA doesn't allow it electronic; it needs to be paper.’ It couldn't be further from the truth.” 

Ramas sees a missed opportunity where the FDA could take a more active role in educating manufacturers and encouraging them to use a more efficient process.  

Another challenge is that critical information in these notices, such as what lots were affected or the distribution dates for the recalled devices, are sent out as unstructured data. 

“Imagine … a hospital receiving a paper alert that shows 23 pages of serial numbers,” Ramas said. “This is happening every day. So, if you’re a recall coordinator at a multi-state health system, think about the task you have in front of you now. You have 23 pages of paper with serial numbers, and you’re supposed to be telling people in hospitals over five states to go check.” 

A hospital supply chain industry group issued a report in 2021 that found healthcare providers spent from 16 to 104 hours per recall. One provider said they processed 42 Class I recalls in a year, costing more than $20,000, according to the report from the Association for Health Care Resource & Materials Management (AHRMM). 

In the worst-case scenario, physicians don’t receive recall information at all or the affected devices aren’t isolated.

“We will see devices get implanted after a recall happens,” Kinard said.  

Sen. Richard Durbin, D-Ill., who requested the GAO’s review, introduced a bill in 2023 that would require manufacturers to send out electronic recall notifications and require the FDA to maintain an electronic, public database of recall notifications.

“I fail to understand why that can’t come straight from the FDA,” Ramas said. 

3. Improve the use of UDIs

Unique device identifiers, labels with specific codes assigned to a medical device, can make products easier to track in the event of a recall. The FDA published a final rule to establish a UDI system in 2013, and manufacturers now incorporate UDIs in the label, as required. But hospitals and payers have been slower to adopt the system, making it “functionally useless,” said Kushal Kadakia, a student at Harvard Medical School and first author of a paper in Health Affairs calling for more accountability of the device recall process.

“We have made this problem unique to devices, because we do track medications. We have national drug codes. We have done it for decades,” Kadakia said. “There’s no reason, to me, that a product that is just as important to my clinical practice and to patient care is for some reason erased.” 

 

UDI information is still not included in many recall notices, and the data is often in an unstructured format. Just a quarter of Class I recall notices between 2018 and 2022 contained UDI information, according to the Health Affairs paper.

In a recall, that means hospital staff must manually check if a recalled lot is on the shelf instead of locating the affected devices in an electronic inventory. To make UDIs work better for hospitals, AHRMM recommends ensuring UDIs are tracked in the recall notice, as well as a health system’s electronic health record and enterprise resource planning software. Providers also said including UDI information would be of “minimal benefit” if it was communicated in a text-based format such as a paper or PDF notice. 

For patients, UDIs are critical to know if a device or implant they received has been recalled. For example, when Allergan recalled some of its textured breast implants due to the risk of a type of lymphoma, many people weren’t even aware they had a recalled implant until they were replacing or removing it, said Maria Gmitro, president and founder of the Breast Implant Safety Alliance. 

“Adoption of something like a UDI is so important because these devices went by different names,” Gmitro said. “As a patient, even if I saw FDA recalled Allergan Biocell, well I didn’t have Allergan, I had McGhan. They don’t realize that the names actually changed.” 

Doctors may not be the ones who communicate about a recall either, as they might not be aware of a recall, or it gets lost in the shuffle between patient address changes, Gmitro said. 

One solution could be to track UDIs on claims forms, adding an incentive for them to be tracked in practice, Kadakia said. Standards group X12 added UDIs to Medicare claims forms in a 2022 update, but the National Committee on Vital and Health Statistics, which advises the Department of Health and Human Services, rejected several updates to the forms. 

 4. Faster and more transparent recalls

After a manufacturer starts a recall, it can take weeks or months for the FDA to post a notice. One reason for the delay is that the FDA is working to classify a recall to determine how serious or widespread the problem is, denoting Class I for the highest-risk events. 

“When it takes six to eight weeks, three months to get a Class I recall issued, even through the voluntary process, then clearly something isn’t working well,” said Teresa Murray, who leads the consumer watchdog office for public interest group PIRG. “There needs to be a way for that to happen as soon as possible because, again, people’s lives are at stake.” 

The FDA updates its medical device recall database after it classifies a recall and later after it terminates a recall, Wieghmink said. Companies are required to submit a written report to the agency when they initiate a correction or removal of a device. The FDA reviews the company’s strategy to address the problem, assesses the health hazard presented by the product and determines if the problem violates statutes or regulations before classifying the recall. 

The language in the notices themselves is geared toward providers and can be very technical, said Shannon Davila, executive director of total systems safety at the safety group ECRI. 

“There's a lot of ambiguity sometimes when these recall notices go out to patients and providers,” Davila said. “It's unclear what the next steps are, who they're supposed to follow up with and contact.” 

Davila recommended that at-home devices have clear instructions for how patients can register them so they can get notified in the event of a recall, and that providers also communicate the importance of registration.

The duration of recalls is also growing. The GAO’s inspection in 2011 found the time between when a recall started and was terminated was an average of about 17 months for Class I recalls.

A group of researchers took a closer look at Class I recalls posted between 2018 and 2022. They found that it took a median of 24 months from recall initiation to termination, and 10 recalls had been going on for more than three years. 

“One thing that has really struck our team is that the time it takes to resolve a recall — from when GAO mapped it in the report in 2011 compared to when our team analyzed it last year — has increased significantly,” Kadakia said.  

The FDA’s Wieghmink said the agency closely monitors recalls that remain open and requests companies to submit periodic status reports.

It’s difficult to know what contributed to the longer times because data about the steps of the process aren’t publicly available. The reason why a recall was considered terminated by the FDA also isn’t public — a fact highlighted by the GAO report. 

“It also begs the question of, should we have clearer metrics that are publicly accountable?” Kadakia said.  

5. Strengthen premarket reviews

The majority of medical devices go through the FDA’s 510(k) pathway, where manufacturers rarely need to do premarket clinical testing, as they merely need to prove that a device is substantially equivalent to a product already on the market, called a predicate device. The authors of the Health Affairs paper noted that most Class I recalls affect devices that have been authorized through the 510(k) pathway. 

“The best way to avoid recalls is to have better premarketing standards,” said Michael Abrams, a senior health researcher with consumer advocacy group Public Citizen. 

He described the situation as a “house of cards,” with predicates allowing cleared devices to be based on technology that is decades old. Meaning, recalls could have wider consequences, because if a company is recalling one device based on a predicate, it could potentially implicate others that were also based on that same product. 

Abrams cited reports of pulse oximeters giving misleadingly high blood oxygen readings to patients with darker skin as an example of the problem. Most pulse oximeters were cleared through the FDA 510(k) pathway, he said. An advisory panel recently recommended new pulse oximeters be required to provide clinical data, with trials that include more participants across all skin tones. 

“We think the FDA should be getting more aggressive about looking at which of these devices are failing in that way and recalling them,” Abrams said. 

Draft guidance published by the agency in September 2023 could help address part of the problem. In the documents, the FDA advised companies to choose predicate devices that have been cleared using well-established methods, met safety and performance standards and don’t have design- or use-related safety problems. The agency also described scenarios when clinical data may be needed to demonstrate substantial equivalence to a predicate. 

6. The FDA should use its recall authority

The FDA has the authority to mandate medical device recalls, but the vast majority are voluntary. 

“They have the ability to enforce and to push and yet they don’t seem to do it that way,” Notisphere’s Ramas said, adding that the agency might take more of a neutral ground because it wants to be seen as collaborative with manufacturers and health systems. 

Kinard, of Device Events, said one reason most recalls are called voluntary is to protect the agency from liability.

“When you’re communicating about a recall, it has to be strong or else people don’t act,” she said. “If they think it’s voluntary, the manufacturers use that to say, ‘We’re just doing this out of an abundance of caution.’” 

Wieghmink said that most recalls are considered voluntary, but the FDA has the authority to take action if a manufacturer fails to do so, particularly if there’s reasonable probability it would cause serious adverse health consequences or death. 

“However, in practice, the FDA has rarely needed to require a medical device recall,” Wieghmink wrote. She added, “Voluntary recalls remain the quickest, most effective way to remove or correct a medical device, its labeling, or marketing in the U.S. until issues are fully resolved.” 

Abrams and Kadakia called for the FDA to get more resources for handling recalls quickly. Kadakia proposed including recall performance goals in the next medical device user fee agreements, which set how much the agency can collect from manufacturers in fees.

Abrams called for more direct funding from Congress rather than fees collected from the industry. When problems arise, the FDA should be able to work with manufacturers and providers to find the faulty devices, and recall or remove them from the market, he said. 

“That does require resources,” Abrams said. “And it requires that the FDA have the authority to do it without fear of retribution from the manufacturers that because of user fees, pay a substantial portion of their operating budget.”

The Food and Drug Administration named Ross Segan as director of the medical device center’s Office of Product Evaluation and Quality (OPEQ), following a nationwide search, an FDA spokesperson confirmed.

The OPEQ, in the FDA’s Center for Devices and Radiological Health, manages the premarket review process for medical devices, as well as recalls, inspections and postmarket safety monitoring.

Segan, a former U.S. Army surgeon who has held senior positions at several large medical device companies, began in September 2024, FDA spokesperson Kristina Wieghmink said in an email to MedTech Dive. His appointment was first reported by STAT.

Segan has also been a consultant for medical device companies and was an observer on the board of directors for Delphi Diagnostics, Wieghmink said.

Segan is a former chief medical officer at Olympus Corp. and held executive positions at Johnson & Johnson and Covidien before that, according to his LinkedIn profile. Olympus faced safety issues raised in FDA warning letters over its endoscopes in early 2023. Segan left the company in March 2023, according to his LinkedIn profile.

Most recently, Segan founded and was managing director of Medical Scientific Advisors.

“I am committed to servant leadership and, most importantly, I am passionate about patients having access to innovative medical technology that is clinically relevant, effective, and safe,” Segan said in the email from Wieghmink.

Segan replaces William Maisel, who retired from the FDA in the spring of 2024 after five years as director of the OPEQ and 14 years with the CDRH. Maisel is now senior medical officer at robot maker Intuitive Surgical, according to Maisel’s LinkedIn profile. Owen Faris, principal deputy director of OPEQ, served as the office’s acting director after Maisel’s departure.

Segan joins the CDRH during a time of transition. Jeff Shuren, who led the center for 15 years, stepped down as director in July 2024. Michelle Tarver, the center’s deputy director for transformation, is now serving as acting CDRH director as the FDA searches for a permanent successor.

Shortly after Shuren retired, The New York Times reported on ethical concerns that arose because his wife, Allison Shuren, represented medical device companies as part of the law firm Arnold & Porter. The FDA defended Shuren’s record after the story was published.

Lawmakers and patient advocates have repeatedly called for the FDA’s product safety system to be strengthened. The FDA’s device recall oversight is the subject of a new U.S. Government Accountability Office review, after Sens. Dick Durbin, D-Ill., and Richard Blumenthal, D-Conn., in December 2023 raised questions about the handling of Philips’ recall of more than 15 million sleep apnea machines and ventilators.

In August 2024, the government watchdog published a report looking at challenges facing the agency’s efforts to expand device safety oversight.

Dive Brief:

The current system for monitoring and recalling medical devices is failing patients, physicians wrote in the journal Health Affairs in February 2024.

With the Government Accountability Office (GAO) reviewing device recalls, the physicians looked at the current process to generate suggestions for improving medical device safety in the U.S.

The physicians advised the GAO to propose ways to clear barriers to the implementation of unique device identifiers (UDIs) and assess how the FDA can better use the National Evaluation System for Health Technology.

Dive Insight:

The GAO last investigated medtech vigilance in 2011, leading to a report that concluded the Food and Drug Administration “should enhance its oversight of recalls.” The report informed the Food and Drug Administration Safety and Innovation Act (FDASIA), which was signed into law in 2012 and addressed three of the four GAO recommendations. Actions by the FDA addressed the fourth recommendation. 

However, an article in the New England Journal of Medicine noted that, while “many experts have called for substantial changes,” FDASIA revisions to the safety of authorized medical devices were “generally limited to ... requests for the FDA to develop frameworks, strategies or processes related to improving postmarketing surveillance and enforcement.”

After reviewing the current situation, the authors of the Health Affairs paper concluded that the existing system is “failing to meet the needs of public health amidst increasing consequential recall frequency and severity.” The conclusion is informed by increases in serious recalls, adverse event reports and the time to termination for Class I recalls.

The physicians have three main recommendations for the GAO. First, the authors are advising the office to consider how “strengthening FDA’s ability to identify safety concerns before device authorization can help reduce the risk of future recalls.” Specific suggestions include reforms to the 510(k) pathway and “new evidence thresholds for supplemental approvals to reduce potential safety risks.”

Second, the physicians are advising the GAO to explore how the FDA and manufacturers “can better collaborate on device recalls,” with a particular focus on “expediting recall timelines.” As part of that suggestion, the authors are suggesting that GAO revisit the UDI recommendation it made in 2011. The FDA acted on the recommendation but adoption of UDIs by payers and providers is limited.

Third, the authors want the GAO to “clarify the contexts in which FDA should be using its existing enforcement authorities.” Sens. Dick Durbin, D-Ill., and Richard Blumenthal, D-Conn., who called for the GAO review, asked about this in several of their questions. By clarifying the situation, the physicians believe the GAO can empower the FDA and “blunt political pressure on the agency.”

The U.S. Government Accountability Office will look into the Food and Drug Administration’s oversight of medical device recalls, the government watchdog confirmed in January 2024 with MedTech Dive.

The probe comes one month after Sens. Dick Durbin, D-Ill., and Richard Blumenthal, D-Conn., asked the GAO to review the FDA’s handling of device recalls, citing Philips’ ongoing recall of more than 15 million respiratory devices.

A GAO spokesperson said in an email that the office hopes to start the work soon, but did not provide information on when the probe will begin and how long it may take.

Meanwhile, a spokesperson for the Center for Devices and Radiological Health said in an email that the agency welcomes the review of its oversight of device recalls. The spokesperson did not say what specifically the GAO will look into and how long the review may take.

ProPublica was first to report the news on Jan. 17, 2024.

Sens. Durbin and Blumenthal urged the GAO to review the FDA’s handling of medical device recalls in a letter to the office in December 2023. Regarding the Philips recall, the senators wrote that it “appears that FDA missed several opportunities to mitigate the harm done to the millions of patients who have used these recalled medical devices.”

The senators asked for an update on a 2011 GAO report of the agency’s oversight of device recalls, listing 10 questions they want the office to take into account. The questions include the extent to which the FDA uses information to improve its recall process, the agency’s authority and actions it has used to ensure manufacturers initiate recalls, what factors may contribute to the likelihood of medical device recalls, and whether additional resources, funding or legislative authorities would improve the FDA’s oversight.

The GAO’s review comes after several years of high-profile device recalls and product safety issues — namely, Philips’ recall of sleep apnea and ventilator machines. The FDA has also faced criticism for its handling of safety problems associated with breast implant products, Bayer’s Essure birth control device and Medtronic’s Heartware ventricular assist device.

Recalled heart devices often lack clinical testing, researchers found in a study published in September 2024 in the Annals of Internal Medicine. 

Heart devices account for one-third of Class I recalls, the Food and Drug Administration’s most serious designation. Researchers found the recalled devices “were infrequently subjected to premarket or postmarket testing, with recalls affecting thousands of patients annually.”

The authors analyzed cardiovascular devices with Class I recalls between 2013 and 2022. During that time, they found 137 Class I recalls affecting 157 unique heart devices. The majority, about 71%, went through the FDA’s 510(k) pathway for moderate risk devices, while the remainder went through the premarket approval (PMA) pathway for high-risk devices. 

Devices that go through the PMA pathway, such as implantable cardioverter-defibrillators and endovascular stent grafts, require proof of clinical evidence of safety and effectiveness, while devices that go through the 510(k) pathway need only prove they are equivalent to a product that’s already been authorized. 

The most common reason for recalls was device design, accounting for about 31% of events. More than half of the recalls recommended stopping further use, and one recommended explantation. 

Clinical testing limited

The researchers found that just 30 of the 157 recalled heart devices underwent premarket clinical testing. The remainder did not, or information was unavailable. 

The 30 devices that underwent clinical testing included seven that received 510(k) clearance, 17 with PMA approval and six with changes approved through PMA supplements. 

Most of the premarket studies were prospective, but they were not randomized or blinded, the authors of the report found. And 18 of the studies did not use a control group. 

Studies also frequently used surrogate markers instead of clinical outcomes as an endpoint, and the majority of studies had composite endpoints, which can be more difficult to interpret. 

“In other words, medical devices later recalled due to safety issues often had little clinical evidence supporting their original authorization,” the authors of the paper wrote.

The authors offered recommendations for strengthening clinical evidence for heart devices, including requiring premarket testing for device types with high rates of recalls. The most recalled heart devices included automated external defibrillators, intra-aortic balloons and implantable cardioverter-defibrillators. 

The researchers also said the FDA could develop standardized schedules for postmarket follow-up based on a device’s relative risk, as was done by the European Union. Or, the agency could use its authority to require more postmarket studies for frequently recalled devices. 

A key limitation of the study was missing information in the FDA’s recall database. Nearly half of recalls before 2017 don’t include information about complaints, injuries or deaths. The study also only considered Class I recalls, which may not capture the full range of patient safety considerations for heart devices, the authors wrote. 

The study was conducted by researchers at the University of California, San Francisco, Yale School of Medicine and Harvard Medical School.

Dive Brief:

The Food and Drug Administration has taken steps to establish an active postmarket surveillance system to monitor medical device safety but has faced two key challenges, according to a government report.

A Government Accountability Office (GAO) investigation, published August 2024, found the FDA plans to start active surveillance for two device types by December 2024 and expand the program over five years.

However, FDA officials told the GAO limited use of unique device identifiers in electronic health records and billing claims and questions about how to fund the work have been key challenges.

Dive Insight:

Federal law adopted in 2012 requires the FDA to establish an active postmarket surveillance system for medical devices. Actively assessing sources of real-world evidence such as electronic health records, billing claims, pharmacy data and registries could accelerate the identification of safety issues and find problems that may otherwise go undetected.

The GAO review of the FDA’s efforts to establish an active surveillance system follows a series of high-profile product safety issues. In recent years, concerns about Philips’ sleep and respiratory devices, Medtronic’s heart pump and Allergan’s breast implants have shone a spotlight on the recall process. Lawmakers and patient advocates have repeatedly called for the FDA’s medical device recall and product safety system to be improved to better protect people.

Reps. Anna Eshoo, D-Calif., and Debbie Dingell, D-Mich., requested the GAO report on the FDA’s postmarket surveillance system. The federal watchdog has also taken up a congressional request from Sens. Dick Durbin, D-Ill., and Richard Blumenthal, D-Conn., to review the agency’s medical device recall process.

The GAO looked at documents and spoke to people from the agency, health systems, a research organization and associations representing patients, healthcare providers and device manufacturers. The resulting report describes what the FDA has done so far, the challenges that could impede progress and what the agency is doing to resolve the problems. 

The GAO found the FDA has conducted three foundational activities for active postmarket surveillance. In partnership with the National Evaluation System for health Technology Coordinating Center (NESTcc), the FDA has organized collaborators to contribute data, built data infrastructure and used stakeholder expertise to plan an active surveillance system.

Building on the foundations, the FDA plans to start active surveillance of duodenoscopes and robotically assisted surgical devices used in gallbladder removal. NESTcc contracted a vendor for the monitoring in October 2023 and began talking to 14 potential data partners in February 2024. As of April 2024, one data partner had agreed to participate. FDA officials estimated active surveillance will begin by December 2024.  

The FDA plans to add four devices to the program each year, resulting in active surveillance of 18 or more medtech products by 2028. The agency wants to add data partners covering 10 million new patients in 2025 and 2026 and continue to expand the network as needed beyond that.

However, the FDA has faced challenges. The GAO found the limited use of unique device identifiers by healthcare providers and payers makes it harder to identify devices that patients use. Unique device identifiers are codes on product labels used by manufacturers to connect a specific medical device to a specific patient. Experts have advocated for their use in recalls and safety alerts so patients can more easily identify if a device they use or have been implanted with is included.

Device manufacturers now use unique device identifiers as required by a 2013 FDA final rule. Still, the GAO report states that the FDA lacks the authority to make providers capture identifiers in electronic health records or use them in billing. The GAO identified actions the FDA has taken to try to encourage adoption, such as “coordinating with federal entities and publishing a document advertising the benefits of use to health systems.”

Funding is the other challenge. The FDA estimates establishing and maintaining an active surveillance system will cost $8 million. The agency plans to allocate $5 million of its current annual appropriations to the project and asked Congress for an additional $3 million to cover the rest. However, the FDA did not receive the requested appropriations increase. 

The FDA has continued to build the system, but officials told the GAO implementing active surveillance without additional funding would mean taking away from other postmarket priorities. The agency has advocated for medical device user fees to cover postmarket surveillance, the GAO said, but that is not likely to be allowed under current law and would require the FDA to work with industry and Congress.

Philips will have to undergo “an incredible undertaking” to meet requirements set out by the Food and Drug Administration in a consent decree, attorneys told MedTech Dive.

The U.S. Department of Justice filed the document on behalf of the FDA in April 2024, barring Philips from selling certain sleep and respiratory products in the U.S. for years until it proves compliance. The action came as Philips continues to work through a recall of more than 15 million sleep apnea machines and ventilators that started in June 2021 due to soundproofing foam breaking down and being inhaled by patients.

The consent decree includes new provisions and actions rarely taken by the agency to help patients affected by the recall, the FDA said in an emailed statement. That includes the agency taking the unusual step of requiring a manufacturer to repair, replace or refund the purchase price of devices.

“When you look back at how many consent decrees FDA enters into, and what the scope of them are, this would be on the more stringent side than I've seen in a while,” said Jamie Ravitz, a partner at the McDermott Will & Emery law firm.

Here are five takeaways from the legal documents:

1. The FDA uses its authority for the first time to require repairs, replacements or refunds

The agency has used its authority in the past to require a recall, but it is “very rare,” said Beth Weinman, an attorney with Ropes & Gray. 

Now, the FDA is using its authority to require a company to submit a plan for the repair, replacement or refund of the recalled devices, which Weinman couldn’t find any instance of the agency doing ever before.

In its statement on the consent decree, the FDA said Philips must come up with a recall remediation plan, agreed to by the agency, that includes the repair, replacement or refund of the purchase price of recalled devices manufactured after November 2015. Philips won’t be able to manufacture or sell certain devices from its Respironics facilities in Pennsylvania or California until it meets this requirement. The agency declined to provide a copy of the remediation plan. 

“My guess about why that is the case here is that you’re dealing with consumer products at the end of the day. A lot of consent decrees in the past have dealt with medical equipment that’s first and foremost being used in hospitals,” said Jennifer Bragg, a partner at Skadden who specializes in healthcare issues. “I think the FDA is trying to create a situation where there will be some opportunity for consumers to, if not be made whole, to be really taken into account when it comes to replacing these devices.”

2. Philips must pay a percentage of profits on devices it can sell

Philips will still be able to manufacture and sell certain devices deemed medically necessary, including bilevel positive airway pressure machines for patients between 40 and 66 pounds, and ventilators and associated accessories, FDA spokesperson Kristina Wieghmink wrote in an email. 

However, the company will have to pay a portion of revenue from those sales to the U.S. Treasury. That amount starts at 10% from now through December 2024, and gradually increases to 25% by 2026. 

Bragg said that the FDA has taken this approach when a company is out of compliance but is selling products that are important to the market, such as where a total ban would create a shortage. The payments are designed to keep the company from “getting too comfortable” because it’s selling products. 

“What I see from that is the government trying to give a very strong incentive to Philips to really expeditiously try to move through and get to compliance under the decree,” Bragg said. She added that being able to sell some devices might seem like a boon, but it can also be a challenge because the company is “fixing the plane while it’s flying.”

3. Philips is required to hire several inspectors and demonstrate compliance for at least 5 years

Philips must bring in three different quality systems experts to monitor its facilities. The company must hire a design expert to check if changes made to the replacement or reworked devices would require Philips to submit a new premarket notification to the FDA. 

Philips must also hire an auditor to inspect the covered facilities for five years. If problems are reported, the FDA can require the auditing cycle to be extended or start over for up to two years. 

Weinman said it’s standard in consent decrees for the covered facility to have to demonstrate five years of continuous compliance. 

“It can take many, many more years,” she said. “That means that every audit, you come out clean for a period of five years.” 

Requiring all of these reports also means that there is a lot of work for Philips and the FDA to do going forward. 

“It’s an incredible undertaking,” Weinman said. “I couldn't tell you how much it costs, but it is a massive investment of resources.”

4. Philips received two warning letters before the consent decree

Two warning letters were sent to Philips years before the consent decree was filed and the recall began. Both were related to inspections at its Murrysville, Pennsylvania, facility, according to a complaint filed by the DOJ in April 2024. A 2011 warning letter was sent to the company regarding an inspection where FDA investigators documented Philips Respironics’ failure to submit medical device reports related to malfunctions with its Trilogy ventilators. In 2014, a separate letter found that Philips failed to monitor and control production to ensure devices conformed to their specifications. 

The complaint said the FDA’s most recent inspections ”documented significant violations, many of which are the same as or similar to violations that have been previously observed at the Defendants’ facilities.” 

Typically, the FDA will issue warning letters and take other actions before it escalates to a consent decree, Ravitz said. 

“They'll go this route, when they feel like there's extenuating circumstances, like a pattern of non-compliance,” he said. 

5. Philips was the subject of another consent decree in 2017

In 2017, Philips was the subject of a consent decree related to quality control problems with Philips North America’s automatic external defibrillators. Some of those facilities were part of Philips’ connected care business segment, which its sleep and respiratory care unit falls under, according to the FDA’s complaint. 

“One of the things that I think it's important to know first is how unusual it is for CDRH to go down the path of seeking a consent decree,” Bragg said. “To me, it's an indication that this was a very important issue from the government's point of view.” 

Weinman said the consent decree and invocation of a rarely used authority reflects “a significant lack of trust.” 

“FDA wants companies to do what they need to do and voluntarily come into compliance,” Weinman said. “I don’t think the agency relishes having to do the work to come up with a plan and a consent decree like this.”

Dive Brief:

Merit Medical Systems has recalled products that contain plastic syringes made by a Chinese manufacturer.

The recall affects kits that include unauthorized syringes manufactured by Jiangsu Shenli Medical Production. The Food and Drug Administration issued an import alert and warning letter against Jiangsu Shenli earlier in 2024 after finding it was providing syringes that were different from its authorized device. 

Merit wrote to customers in June 2024 after learning that it received Jiangsu Shenli syringes from a supplier. The company has asked customers to stop using the syringes.

Dive Insight:

The FDA’s investigation into the potential for plastic syringes made in China to leak, break and otherwise suffer quality problems led it to Jiangsu Shenli. Officials accused the company of marketing 29 sizes and configurations of piston syringes without clearance or approval.

Medline Industries received a warning letter linked to its distribution of the Jiangsu Shenli syringes and recalled its devices in May 2024 and June 2024.

Merit sent an urgent medical device recall notice about its distribution of Jiangsu Shenli syringes. The company said it included the syringes in multiple products. Customers can continue to use the other components included in the kits but should immediately stop using and distributing the syringes. 

As Merit is moving away from Jiangsu Shenli syringes, it may ship kits that contain the devices to avoid product shortages during a transition period. The company will apply a recall label to affected syringes. 

The action affects 110,000 devices, according to the FDA’s Class 2 recall notice. The notice applies to disposable luer lock syringes that Merit sells under the Medigrative brand and lists Jiangsu Shenli as the recalling firm.

Jiangsu Shenli has asked customers to dispose of recalled syringes in the U.S. using their established procedures or by working with a local third party. Customers should “report the destruction method and cost with Shenli before final implementation,” according to the notice.

Merit’s recall comes days after the FDA announced additional recalls by Medline. The company began recalls of luer lock disposable syringes shortly after an initial action that affected 2.3 million devices.

Breast implants are causing a rare and potent form of cancer, and U.S. regulators may have been slow to warn of the danger, say doctors and patient advocates who have been reporting on the risks for years.

So far, with more than 300,000 breast implant procedures annually in the U.S., squamous cell carcinoma — a potentially aggressive tumor that develops in the scar tissue around the implant — has been detected in at least 19 cases, the Food and Drug Administration said in March 2023. Three of the cases resulted in death, according to the reports, which the FDA compiled from clinical literature. 

The cancer can appear as much as 20 years after surgery, the agency added.

Patient advocates “have been sounding the alarm for years,” Maria Gmitro, president of the Breast Implant Safety Alliance, wrote in an email. She said the public might have been alerted earlier if the FDA had enforced required postmarket studies of the implants.

In 2006, when the FDA approved Allergan and Mentor Worldwide’s silicone gel-filled breast implants, the FDA required large, postmarket studies to better understand rare events and long-term outcomes. But by 2011, the manufacturers admitted they had lost track of many patients after implantation. In 2019 and 2020, the agency issued warning letters to Mentor, Sientra and Allergan for failing to follow up with patients in post-approval studies of their implants.

“Had the post-approval studies been continued and patients followed for symptoms, the public would have better data and information which was a missed opportunity that directly impacts patient safety today,” Gmitro said in a statement. Gmitro had her own breast implants removed in 2017 after three years of what she calls “continued health complications.”

One of the first reports of squamous cell carcinoma linked to breast implants surfaced in 1992, when plastic surgeons at St. Louis University School of Medicine noted the cancer was found 15 years after a woman had a breast augmentation procedure. Since then, more reports of the implant-associated cancer have accumulated, and even Facebook groups have formed: one for Breast Implant Associated Squamous Cell Carcinoma dates back to 2020. 

The FDA first flagged the problem in September 2022, noting 10 reports of the cancer. At the time, the agency said it did not have enough information to say whether breast implants cause the cancer, or if some implants pose a higher risk than others. 

In an email, an FDA spokesperson wrote that the agency’s review was prompted by its “continual postmarket safety review of breast implants, including manufacturers’ compliance with post-approval studies, and collaboration with external stakeholders.”

“As we stated in September when the FDA issued the first safety communication about SCC, while we continue to believe that occurrences of SCC in the capsule around the breast implant may be rare, the cause, incidence and risk factors remain unknown,” the agency added.

Challenges counting

Challenges in reporting the cancer make it difficult to know the true number of cases. As of Jan. 15, 2023, the FDA said it has received 24 medical device reports of squamous cell carcinoma related to breast implants, but these don’t necessarily represent cancer incidence because of potential duplicate reports or underreporting, the agency said.

Dr. Scot Glasberg, president-elect of the Plastic Surgery Foundation, said he knew of 16 squamous cell carcinoma cases from literature, and another 23 from de-identified data. “While it’s a rare tumor, the concern is that it's fairly aggressive,” Glasberg said. 

A review, published online in February 2023 in Clinics in Plastic Surgery, counted 20 reported cases of squamous cell carcinoma associated with breast implants. Within six months, 43% of people who contract the cancer die, the review found. 

Dr. Mark Clemens, the article’s corresponding author and a professor of plastic surgery at MD Anderson Cancer Center in Houston, said he thinks there are more cases than the 19 that the FDA disclosed in its report.

“Probably not exponentially more. I do think there are additional ones,” he said, adding that he was aware of about 10 other cases. 

There are fewer cases of squamous cell carcinoma linked to implants than other breast implant-associated cancers. For example, there are more than 1,300 known cases of breast implant-linked anaplastic large cell lymphoma (BIA-ALCL), a cancer of the immune system, Clemens said. There have also been about 30 reported cases of another cancer, known as B-cell lymphoma, according to the review. 

Patient registries traditionally only collected data on breast implant-linked anaplastic large cell lymphoma. The National Breast Implant Registry — a collaboration between the Plastic Surgery Foundation, the FDA, patients and implant manufacturers — started capturing data about squamous cell carcinoma and other lymphomas in late 2022. In March 2023, the FDA told healthcare providers that they can submit case reports of squamous cell carcinoma and other implant-related cancers to the PROFILE Registry,  which was created to track cases of breast-implant associated anaplastic large cell lymphoma.

Even now, the data is collected only from plastic surgeons, Gmitro said, while these cases might be detected by oncologists, gynecologists, general practitioners or other physicians.

And since cases of squamous cell carcinoma are detected an average of 20 years after implantation, there’s a chance that the original surgeon may no longer be practicing, leaving patients to seek follow-up treatment from other practitioners. Or, the brand name of the implant may have changed, Gmitro said, adding that this also makes cases difficult to track. 

The first step to identifying the scope of the problem is to require all doctors and medical practitioners to report any cases of cancer linked to implants directly to the FDA, she added.

Recent scrutiny

Breast implants last faced scrutiny in 2021 when the FDA told implant makers Allergan, Ideal Implant, Sientra, and Johnson & Johnson subsidiary Mentor to put black box warnings on the device labeling, informing doctors and patients about the risk of cancer and other complications, and to make it clear that the implants don’t last for a patient’s lifetime. 

The agency also said that healthcare providers and facilities selling the devices must review a decision checklist with patients prior to surgery, which includes information on the rates of breast implant-linked anaplastic large cell lymphoma associated with the devices. But it hasn’t yet included the same requirement for squamous cell carcinoma. 

Some people who have gotten implants may also develop breast implant illness, a term used to describe systemic symptoms including fatigue, brain fog, and joint or muscle pain, according to the FDA.

Despite these concerns, the number of procedures has increased.

In 2021, despite the pandemic, surgeons performed 365,000 breast augmentations, and 148,000 people had implants removed and replaced, according to the Aesthetic Society, a professional group for plastic surgeons. By comparison, there were 280,692 breast augmentations in 2019. 

In addition, 71,000 people had their implants removed and not replaced, an increase from 2019.

In total, breast augmentation procedures alone brought $1.54 billion in revenue in 2021 to U.S. plastic surgery practices, the Aesthetic Society reported.

Diagnosis and treatment

While the anaplastic large cell lymphoma is associated only with textured implants, cases of squamous cell carcinoma have been reported in all types of breast implants. A potential cause could be localized immune suppression directly around the implant linked to inflammation, MD Anderson’s Clemens said. 

The difference in prognosis between the cancers is stark: While most people with anaplastic large cell lymphoma who have limited disease are able to achieve complete remission, nearly half of people with squamous cell carcinoma die within six months, according to Clemens’ review. 

The cases are linked to the implant, the Plastic Surgery Foundation’s Glasberg said, noting “the pathology of the capsules [the scar tissue around the implant] seems to suggest that the tumor is emanating from the capsule.”

People with breast-implant related cancers experience symptoms including pain, swelling, fluid buildup and redness, although squamous cell carcinoma is more likely to show up as a mass spreading outside of the scar tissue around the implant, according to an article published in Clinics in Plastic Surgery. 

While signs of these cancers can show up in a regular screening or mammogram, they are not specific to these cancers and can overlap with benign implant complications, wrote Jennifer Cook, director of BIA-ALCL advocacy for the Breast Implant Safety Alliance, in an emailed statement. 

The cancer may go unrecognized if the radiologist reading the image is not up to date in their knowledge or if the cancer risk is deemed too remote to justify a biopsy or costly next steps, Cook said, adding that an MRI or ultrasound is usually better than a mammogram at detecting signs of the cancer.

The American Society of Plastic Surgeons recommends surgeons send biopsies to be tested for squamous cell carcinoma in addition to BIA-ALCL for diagnosis, said Glasberg, a former president of the society. Ahead of a planned implant removal, the group also recommends an MRI to detect whether there could be a tumor in the scar tissue closer to the chest wall, so that a surgeon is prepared if more extensive surgery is needed. 

Even when a cancer linked to breast implants is discovered, many patients find that while insurance companies will cover implant removal and reinsertion for people who underwent breast reconstruction, only 17% cover it in cases of augmentation and many explicitly deny cancer treatment if the patient had a prior history of cosmetic surgery, according to the review. 

“They are getting denied diagnosis and treatment,” Clemens said, adding that clinical societies are lobbying to change this.

Informed consent

The FDA appears concerned enough about the cancer risks that it is asking manufacturers to add information about the risks of squamous cell carcinoma to device labeling, and although that hasn’t yet been made a requirement, “my guess is in some short order they will,” Glasberg said. 

The agency said it hopes that increased awareness of this issue “may result in reporting of additional cases so the FDA can further evaluate the issue and have a better understanding of the risk,” the spokesperson wrote in an email. “We will continue to inform the public as any new significant information is available.”

Gmitro of the Breast Implant Safety Alliance would also like patients to be told that implants can cause squamous cell carcinoma, as part of the informed consent checklist patients receive before surgery. 

“We still have concerns about how this information is presented to the patient since there is no mandate or accountability system in place. Also, there is still no mechanism in place to warn patients when safety issues arise, which BISA believes should [also] be a requirement,” Gmitro said. 

“You have a car. They find you when there’s a problem with the car. Why can’t we do this with devices implanted in our bodies?” she asked.