Understanding a decade of safety reporting for sacral neuromodulation in the Food and Drug Administration Manufacturer and User Facility Device Experience database.

INTRODUCTION: Over 350 000 sacral neuromodulation (SNM) devices have been implanted since approval by the Food and Drug Administration (FDA) in 1998. SNM technology and clinical applications have evolved, with minimal safety updates after initial trials. We aim to provide an updated overview of real-world SNM safety. These insights will guide informed consent, preoperative counseling, and patient expectation-setting. MATERIALS AND METHODS: The FDA Manufacturer and User Facility Device Experience (MAUDE) database is a repository for medical device safety reports. We performed MAUDE categorical (1/1/98-12/31/10) and keyword (1/1/11-9/30/21) searches for "Interstim." A random sample of 1000 reports was reviewed and categorized by theme. To corroborate our MAUDE database analysis, a legal librarian searched the Public Access to Court Electronic Records (PACER) database, as well as Bloomberg Law's dockets database for all lawsuits related to SNM devices. RESULTS: Our search of the MAUDE database returned 44 122 SNM-related adverse events (AEs). The figure illustrates the prevalence of event categories in the random sample. The largest proportion of reports (25.6%) related to a patient's need for assistance with device use, followed by loss/change of efficacy (19.0%). Interestingly, a fall preceded issue onset in 32% of non-shock pain, 30% of lead/device migration, and 27% of painful shock reports. Our legal search revealed only four lawsuits: one for patient complications after an SNM device was used off-label, one case of transverse myelitis after implant, one for device migration or poor placement, and the fourth claimed the device malfunctioned requiring removal and causing permanent injury. CONCLUSIONS: This review confirms the real-world safety of SNM devices and very low complication rates as seen in the original clinical trials. Our findings indicate that 43.2% (95% confidence interval 40.1%-46.3%) of SNM "complications" are not AEs, per se, but rather reflect a need for improved technical support or more comprehensive informed consent to convey known device limitations to the patient, such as battery life. Similarly, the number of lawsuits is shockingly low for a device that has been in the market for 24 years, reinforcing the safety of the device. Legal cases involving SNM devices seem to relate to inappropriate patient selection-including at least one case in which SNM was used for a non-FDA approved indication-lack of appropriate follow-up, and/or provider inability to assist the patient with utilizing the device after implantation.

Manufacturer and User Facility Device Experience Reporting of Events Related to Transvaginal Mesh: Understanding the Data.

OBJECTIVE: The aim of this study was to examine potential bias in reports to the Manufacturer and User Facility Device Experience (MAUDE) database involving vaginal mesh by identifying the party submitting the report, the nature of the complaints, and whether the reports were edited. METHODS: All reports submitted to the MAUDE database involving synthetic transvaginal mesh from January 2000 through December 2017 (40,266 safety reports) were identified. A random 2% sample (900) of these reports was reviewed in depth to determine the specific relevant details, including reporter type (patient, manufacturer, lawyer) and details of the complaint/injury. RESULTS: Of the 40,226 reports to MAUDE identified, 28,473 (70.7%) were sling reports, and 11,793 (29.3%) described mesh products augmenting pelvic organ prolapse repair. Of the 900 reports reviewed in depth, 46%, 41%, 10%, and 2% of entries were reported by the manufacturer, attorney, health care provider, and patients, respectively. In the 4 years after submission, 18.6% of reports were modified at least once. CONCLUSIONS: The MAUDE database allows physicians, manufacturers, and patients to immediately report adverse events experienced due to medical devices. While this database is an important means to identify potential danger to patients, any individual can file a report and, thus, it should not be the sole source of evidence to consider when assessing device safety. Further, the MAUDE database provides no information into the total number of cases performed without complication.

The importance of data source in prescription drug monitoring program research.

OBJECTIVE: To develop a legal research protocol for identifying various measures of prescription drug monitoring program (PDMP) start dates, apply the protocol to create a useable PDMP database, and test whether the different legal databases that are meant to contain the same information produce divergent results when used in an illustrative empirical exercise. DATA SOURCES: Original research from state statutes, regulations, policy statements, and interviews; alternative PDMP data from the National Alliance for Model State Drug Laws and Prescription Drug Abuse Policy System; claims from a 40 percent random sample of Medicare beneficiaries, 2006-2014. STUDY DESIGN: Collaborative research effort among a group of lawyers to develop protocol. Legal research to produce an original database of dates state PDMP laws: (a) were enacted, (b) became operational, and (c) required query before prescribing controlled substances. Descriptive analyses characterize differences in dates of enactment, operation, and must query requirements. Regression analyses estimating, for each beneficiary annually any opioid prescription received in a calendar year, among other measures. Estimates conducted on under age 65 and full Medicare population. DATA COLLECTION/EXTRACTION METHODS: PDMP legal databases were linked to annual Medicare claims. PRINCIPAL FINDINGS: An original database differs from commonly used, publicly available data. Outcomes tested depend on the measure of PDMP date used and differ by data source. Must-query laws show the largest effects among all the laws tested. CONCLUSIONS: Data choices likely have had large consequences for study results and may explain contradictory outcomes in prior research. Researchers must understand and report protocol for dates used in PDMP research to ensure that results are internally consistent and verifiable.

Regulating Opioid Supply Through Insurance Coverage.

Responding to an opioid crisis in Canada, policy makers have implemented supply-side interventions seldom used in the US, regulating insurance reimbursement to discourage the prescribing of specified opioids. Using national databases of all opioids dispensed through provincial pharmaceutical programs and of opioid hospitalizations from January 2006 through March 2017, we found that requiring physicians to obtain prior authorization for patients to receive reimbursement for OxyContin prescriptions substantially reduced OxyContin fills, particularly among opioid-naive patients; it also reduced overall opioid prescriptions, suggesting limited substitution. "Grandfathering" OxyNeo (an abuse-resistant OxyContin variant), allowing previous OxyContin patients to obtain OxyNeo, increased OxyNeo fills but had no detectable effect on total opioid prescriptions, which points to substantial opioid substitution among chronic users of prescription opioids. We found no effects of regulatory changes on opioid-related hospitalizations. These results suggest that restrictions on pharmaceutical formularies can reduce fills of targeted opioids with the additional benefit of altering treatment of opioid-naive and other patients differently. Canadian policy makers may wish to extend such regulations to more provincial formularies and private insurers, and policy makers in the US and elsewhere could fruitfully follow suit.

Vaginal laser treatment of genitourinary syndrome of menopause: does the evidence support the FDA safety communication?

IMPORTANCE: Genitourinary syndrome of menopause (GSM) is a chronic, progressive condition frequently manifesting as vaginal dryness and pain with intercourse. Survey data indicate this is a highly prevalent, likely underreported, condition that profoundly affects quality of life for millions of women. Vaginal lasers demonstrate promise as an effective, nonhormone therapeutic alternative for GSM; however, the risks associated with them may have been overstated. OBJECTIVE: Despite reports of improved sexual and vaginal comfort without serious safety concerns, the Food and Drug Administration (FDA) issued a 2018 safety communication warning against it. We conducted a systematic literature review and surveyed both the FDA Manufacturer and User Facility Device Experience (MAUDE) and Bloomberg Law Databases to evaluate risks associated with laser treatment for GSM. EVIDENCE REVIEW: A systematic literature review identified articles published before September 2019. The MAUDE database was searched by name from 2009 to 2019 for safety claims for 24 vaginal laser devices. The Bloomberg Law database was searched for product liability claims against any vaginal laser device manufacturer before July 2019. FINDINGS: Literature review revealed 3 publications detailing 29 presumptive laser-associated complications, only 5 of which (17.2%) reported worsening symptoms after treatment. The MAUDE database contained 120 complaints; only 30 (25%) detailed potential adverse patient events, most frequently pain (n = 12) and burning (n = 10). The Bloomberg law database contained no claims asserting harm from device use. CONCLUSIONS AND RELEVANCE: Lacking strong evidence indicating significant patient risk for vaginal laser treatment of GSM, the FDA safety communication appears unsubstantiated and implies gender bias. Identified complications suggest most reported "adverse events" represent lack of treatment effect. The well-documented benefits and low risk of adverse event suggest laser therapy for GSM is reasonable with appropriate pretreatment counseling. Additional randomized, well-controlled clinical trials are needed to further elucidate both the safety and efficacy of this nonhormone therapy.

Robotic urologic surgery: trends in litigation over the last decade.

There is a lack of information regarding malpractice claims and indemnity payments associated with robotic cases in surgery. Malpractice claims and indemnity payouts will elucidate and mitigate harms of future adoption of new technology into surgery. We analyzed claims filed against Intuitive Surgical, Inc. from 2000 to 2017. A law librarian identified product liability claims from 2000 to 2017 with the defendant "Intuitive Surgical, Inc." using the Bloomberg Law database. We reviewed all available legal documents pertaining to identified claims, and extracted data points including filing date, surgery date, surgery type, robot type, instrument type, complications, and case outcomes. Since 2000, 123 claims were filed; 108 met criteria for inclusion. Gynecologic surgeries comprised the majority of claims (62%, 67 claims), followed by urologic surgeries (20%, 22 claims). Number of claims filed peaked in 2013 (30%, 32 claims) and then decreased each year, with 6% (7 claims) filed in 2016, and only 1% (1 claim) filed in 2017. Of the 22 claims regarding robotic urologic surgeries, 19 claims (86%) pertained to prostatectomy. Commonly alleged injuries in urologic cases were bowel injury (8 claims), erectile dysfunction (5 claims), bowel fistulas (4 claims), and incontinence (4 claims). Device failure was cited in only 2 claims. Early adopters of robotic surgery were at highest risk of litigation. This risk subsequently decreased despite the wide spread adoption of this technology. Almost all claims were secondary to surgical complications and not device failure, thus demonstrating a need for more systematic training for novel devices and early adopters.

The Truth Behind Transvaginal Mesh Litigation: Devices, Timelines, and Provider Characteristics.

OBJECTIVES: Following Food and Drug Administration communications about the safety of transvaginal prolapse, more than 73,000 patients with complications from treatment of pelvic organ prolapse (POP) or stress urinary incontinence (SUI) have filed product liability claims. This research analyzes the transvaginal mesh claims filed in the United States to identify key characteristics that may inform clinical decision-making. METHODS: We evaluated a 1% random sample from the Bloomberg Law Database: 2000 to 2014 and associated legal documents. Outcomes and measures used included annual rate of claim, mesh type, time interval between surgery and claim, defendants, and surgeon training. RESULTS: The search returned 76,865 results, and 2979 were excluded, leaving 73,915 claims. Of 739 claims (1%), 63.3% involved slings for SUI, 13.3% mesh for POP, and 165 (23.2%) involved both. The mesh named most often in claims was retropubic slings at 30.3% and transobturator slings at 27.1%. The number of cases filed increased significantly from 730 in 2011 to 11,798 in 2012, which then almost tripled in 2013 to 34,017. The interval from surgery to claim filing ranged from 4.8 to 5.3 years. Only 12% of implanting surgeons were or became board certified in Female Pelvic Medicine and Reconstructive Surgery. Only 4 cases named providers as codefendants. CONCLUSIONS: Most legal claims involved slings for SUI and began after the 2011 Food and Drug Administration communication about mesh for POP. The rise in lawsuits does not reflect the acceptably low complication rates for slings for SUI reported in the literature.

State Legal Restrictions and Prescription-Opioid Use among Disabled Adults.

BACKGROUND: In response to rising rates of opioid abuse and overdose, U.S. states enacted laws to restrict the prescribing and dispensing of controlled substances. The effect of these laws on opioid use is unclear. METHODS: We tested associations between prescription-opioid receipt and state controlled-substances laws. Using Medicare administrative data for fee-for-service disabled beneficiaries 21 to 64 years of age who were alive throughout the calendar year (8.7 million person-years from 2006 through 2012) and an original data set of laws (e.g., prescription-drug monitoring programs), we examined the annual prevalence of beneficiaries with four or more opioid prescribers, prescriptions yielding a daily morphine-equivalent dose (MED) of more than 120 mg, and treatment for nonfatal prescription-opioid overdose. We estimated how opioid outcomes varied according to eight types of laws. RESULTS: From 2006 through 2012, states added 81 controlled-substance laws. Opioid receipt and potentially hazardous prescription patterns were common. In 2012 alone, 47% of beneficiaries filled opioid prescriptions (25% in one to three calendar quarters and 22% in every calendar quarter); 8% had four or more opioid prescribers; 5% had prescriptions yielding a daily MED of more than 120 mg in any calendar quarter; and 0.3% were treated for a nonfatal prescription-opioid overdose. We observed no significant associations between opioid outcomes and specific types of laws or the number of types enacted. For example, the percentage of beneficiaries with a prescription yielding a daily MED of more than 120 mg did not decline after adoption of a prescription-drug monitoring program (0.27 percentage points; 95% confidence interval, -0.05 to 0.59). CONCLUSIONS: Adoption of controlled-substance laws was not associated with reductions in potentially hazardous use of opioids or overdose among disabled Medicare beneficiaries, a population particularly at risk. (Funded by the National Institute on Aging and others.).