References
- Abraham, J. (2002). Drug safety and the safety of patients: The challenge to medicine and health from permissive expert risk assessments of triazolam (Halcion). Health, Risk and Society, 4(1), 19–29.
- Alaszewski, A. (2011). Drugs, risk and society: Government, governance or governmentality? Health, Risk and Society, 13(5), 389–396.
- Altenstetter, C. (2011). Medical device regulation and nanotechnologies: Determining the role of patient safety concerns in policymaking. Law and Policy, 33(2), 227–255.
- Ardaugh, B. M., Graves, S. E., & Redberg, R. F. (2013). The 510(k) ancestry of a metal-on-metal hip implant. New England Journal of Medicine, 368(2), 97–100.
- Bauman, J. (2012). Déjà vu effect: Evaluation of United States medical device legislation, regulation, and the food and drug administration’s contentious 510(k) program. Food and Drug Law Journal, 67, 337–361.
- Beaussier, A., Demeritt, D., Griffiths, A., & Rothstein, H. (2016). Accounting for failure: Risk-based regulation and the problems of ensuring healthcare quality in the NHS. Health, Risk and Society, 18(3–4), 205–244.
- Bergsland, J., Ole, J. E., & Fosse, E. (2014). Barriers to medical device innovation. Medical Devices: Evidence and Research, 7, 205–209.
- Carpenter, D., Connolly, D. N., & Kass Lempert, L. (2017). Substantial equivalence standards in tobacco governance: Statutory clarity and regulatory precedent for the FSPTCA. Journal of Health Politics, Policy and Law, 42(4), 607–644.
- Consumer Reports. (2012, May). Dangerous medical implants and devices: Most medical implants have never been tested for safety. Consumer Reports. Retrieved from https://www.consumerreports.org/cro/magazine/2012/04/cr-investigates-dangerous-medical-devices/index.htm
- Currie, G., Humphreys, M., Waring, J., & Rowley, E. (2009). Narratives of professional regulation and patient safety: The case of medical devices in anaesthetics. Health, Risk and Society, 11(2), 117–135.
- Davis, C., & Abraham, J. (2011a). A comparative analysis of risk management strategies in European Union and United States pharmaceutical regulation. Health, Risk and Society, 13(5), 413–431.
- Davis, C., & Abraham, J. (2011b). Desperately seeking cancer drugs. Sociology of Health and Illness, 13(5), 731–747.
- Day, C. S., Park, D. J., Rozenshteyn, F. S., Owusu-Sarpong, N., & Gonzalez, A. (2016). Analysis of FDA-approved orthapaedic devices and their recalls. Journal of Bone and Joint Surgery, 98(6), 517–524.
- Devlin, H. (2017b, September). Revealed: Johnson & Johnson’s ‘irresponsible’ actions over vaginal mesh implant. The Guardian. Retrieved from https://www.theguardian.com/society/2017/sep/29/revealed-johnson-johnsons-irresponsible-actions-over-vaginal-mesh-implant
- Devlin, J. (2017a, December). New Zealand bans vaginal mesh implants. The Guardian. Retrieved from https://www.theguardian.com/science/2017/dec/12/new-zealand-bans-vaginal-mesh-implants
- Drake, F. (2011). Protesting mobile phone masts: Risk, neoliberalism, and governmentality. Science, Technology and Human Values, 36(4), 522–548.
- DrugWatch. (2017). Transvaginal mesh lawsuits. Retrieved from https://www.drugwatch.com/transvaginal-mesh/lawsuit/
- Epstein, S. (1995). The construction of lay expertise: AIDS activism and forging of credibility in the reform of clinical trials. Science, Technology, & Human Values, 20(4), 408–437.
- Faulkner, A. (2009). Medical technology into healthcare and society: A sociology of devices, innovation and governance. Basingstoke, UK: Palgrave MacMillan.
- Food and Drug Administration. (2008, October 20). FDA public heal notification: Serious complications associated with transvaginal placement of surgical mesh for pelvic organ [Public Health Notification]. Retrieved from https://www.gpo.gov/fdsys/pkg/USCOURTS-ca4-15-01454/pdf/USCOURTS-ca4-15-01454-1.pdf
- Food and Drug Administration. (2009). Strategic plan for risk communication. Retrieved from http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/ucm183673.htm#update
- Food and Drug Administration. (2010, August). 510(k) Working Group: Preliminary report and recommendations [Internal Evaluation]. Retrieved from https://www.fda.gov/downloads/aboutfda/centersoffices/CDRH/cdrhreports/UCM220784.pdf
- Food and Drug Administration. (2011a). Communicating risks and benefits: An evidence-based user’s guide. Retrieved April 24, 2016, from http://www.fda.gov/ScienceResearch/SpecialTopics/RiskCommunication/.
- Food and Drug Administration. (2011b, July). Update on serious complications associated with transvaginal placement of surgical mesh for pelvic organ prolapse [Public Health Notification]. Retrieved from https://www.fda.gov/downloads/medicaldevices/safety/alertsandnotices/ucm262760.pdf
- Food and Drug Administration. (2014a, July 28). The 510(k) program: Evaluating substantial equivalence in premarket notifications [510(k)]: Guidance for industry and food and drug administration staff. Retrieved from https://www.fda.gov/downloads/MedicalDevices/…/UCM284443.pdf
- Food and Drug Administration. (2014b, June 26). Regulatory controls. Retrieved from http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/GeneralandSpecialControls/ucm2005378.htm#special
- Food and Drug Administration. (2014c, August 22). Evaluation of sex-specific data in medical device clinical studies: Guidance for industry and food and drug administration staff. Retrieved from https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM283707.pdf
- Food and Drug Administration. (2016, January 4). FDA strengthens requirements for surgical mesh for the transvaginal repair of pelvic organ prolapse to address safety risks [Press Release]. Retrieved from https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm479732.htm
- Food and Drug Administration. (2018a, March 28). FDA mission. Retrieved from https://www.fda.gov/aboutfda/whatwedo/default.htm
- Food and Drug Administration. (2018b, February 1). Premarket notification 510(k). Retrieved from http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/PremarketNotification510k/default.htm
- Food and Drug Administration. (2018c, September 4). How to find and effectively use predicate devices. Retrieved from https://www.fda.gov/medicaldevices/deviceregulationandguidance/howtomarketyourdevice/premarketsubmissions/premarketnotification510k/ucm134571.htm
- Food and Drug Administration. (2018d, January 3). FDA facts: Postmarket patient registry ensures access to safe and effective devices. Retrieved from http://www.fda.gov/AboutFDA/Innovation/ucm484826.htm
- Food and Drug Administration. (2018e, March 15). Reclassification. Retrieved from https://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/CDRHTransparency/ucm378724.htm
- Food and Drug Administration. (2018f, March 8). Recalls, corrections and removals (devices). Retrieved from http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/PostmarketRequirements/RecallsCorrectionsAndRemovals/
- Fox, D. M., & Zuckerman, D. M. (2014). Regulatory reticence and medical devices. Milbank Quarterly, 92(1), 151–159.
- Garcia, A., & Monlezon, D. J. (2015). Global convergance on the bioethics of surgical implants. BioMed Research International, 1–4. doi:10.1155/2015/853125
- Government Accountability Office. (2009). Shortcomings in fda’s premarket review, postmarket surveillance, and inspection of device manufacturing establishments (GAO-09-370T). Retrieved from https://www.gao.gov/products/GAO-09-370T
- Institute of Medicine. (2011a). Medical devices and the public’s health: The FDA 510(k) clearance process at 35 years. Washington, DC: National Academies Press.
- Institute of Medicine. (2011b). Medical Devices and the Public’s Health: The FDA 510(k) Clearance Process at 35 Years (Report Brief). Washington, DC: National Academies Press. Retrieved from http://www.nationalacademies.org/hmd/~/media/Files/Report%20Files/2011/Medical-Devices-and-the-Publics-Health-The-FDA-510k-Clearance-Process-at-35-Years/510k%20Clearance%20Process%202011%20Report%20Brief.pdf
- Jakimovska, K. K., Glavas-Dodov, M., Tonic-Ribarska, J., & Trajkovic-Jolevska, S. (2013). Medical device risk management and its economic impact. Macedonian Pharmaceutical Bulletin, 59(1, 2), 49–60.
- Karpowicz, L., Bell, E., & Racine, E. (2016). Ethics oversight mechanisms for surgical innovation: A systematic and comparative review of arguments. Journal of Empirical Research on Human Research Ethics, 11(2), 135–164.
- Kent, J., & Faulkner, A. (2002). Regulating human implant technologies in Europe: Understanding the new era in medical device regulation. Health, Risk and Society, 4(2), 189–209.
- Leiter, V., & White, S. K. (2015). Enmeshed in controversy: Claims about the risks of vaginal mesh devices. Health, Risk and Society, 17(1), 64–80.
- Leiter, V., White, S. K., & Walters, A. N. (2017). Adverse events reports associated with vaginal mesh: An interrupted time series analysis. Women’s Health Issues, 27(3), 279–285.
- Leonard, S. (2012, April). Serious adverse events triple in three years: Is risk or reporting to blame? Medical Device and Diagnostic Industry. Retrieved from https://www.mddionline.com/serious-adverse-events-triple-three-years-risk-or-reporting-blame
- Markey, E., & Offices of the Congressman. (2012). Defective devices, destroyed lives: Loophole leaves patients unprotected from flawed medical devices. Retrieved from U.S. Senate website https://www.markey.senate.gov//imo/media/doc/Defective%20Devices%20Destroyed%20Lives%20FINAL.pdf
- Maschke, K. J., & Gusmano, M. K. (2016). Evidence and access to biomedical interventions: The case of stem cell treatments. Journal of Health Politics, Policy and Law, 41(5), 918–937.
- Merrill, R. A. (1994). Regulation of drugs and devices: An evolution. Health Affairs, 13(3), 47–69.
- Nygaard, I. (2008). What does ‘FDA Approved’ mean for medical devices? Obstetrics and Gynecology, 111(1), 4–6.
- Osimani, B. (2010). Pharmaceutical risk communication: sources of uncertainty and legal tools of uncertainty management. Health, Risk & Society, 12(5), 453-469. doi:10.1080/13698575.2010.509493
- Osimani, B. (2013). The precautionary principle in the pharmaceutical domain: A philosophical enquiry into probabilistic reasoning and risk aversion. Health, Risk and Society, 15(2), 123–143.
- Pinnow, E., Herz, N., Loyo-Berrios, N., & Traver, M. (2014). Enrolment and monitoring of women in post-approval studies for medical devices mandated by the food and drug administration. Journal of Women’s Health, 23(3), 218–223.
- Ritsick, J., Cormier, J. W., & Fleder, J. R. (2013, October 1). Did the FDA shed light on the meaning of ‘Market Withdrawal’ in the updated RPM? Unfortunately, No. (Blog). Retrieved from https://www.tandf.co.uk//journals/authors/style/reference/tf_APA.pdf
- Rothstein, H. (2006). The institutional origins of risk: A new agenda for risk research. Health, Risk and Society, 8(3), 215–221.
- Somberg, J. C., McEwen, J., & Molnar, J. (2014). Assessment of cardiovascular and noncardiovascular medical device recalls. American Journal of Cardiology, 113(11), 1899–1903.
- Sorenson, C., & Drummond, M. (2014). Improving medical device regulation: The United States and Europe in perspective. Milbank Quarterly, 92(1), 114–150.
- US Department of Commerce. (2016). 2016 top markets report: Medical devices: A market assessment tool for US exporters. Retireved from international trade administration website https://www.trade.gov/topmarkets/pdf/Medical_Devices_Top_Markets_Report.pdf
- US Office of the Law Revision Council. (2017). 21 USC 360l: Postmarket Surveillance.
- US Senate Hearing. (2011). A Delicate Balance: FDA and the Reform of the Medical Device Approval Process before the Special Committee on Aging, Senate, 112th Cong.
- Wall, L. L., & Brown, D. (2010). The perils of commercially driven surgical innovation. American Journal of Obstetrics and Gynecology, 202(1), 30.e1-e4.
- Wizemann, T. (2010). Public health effectiveness of the FDA 510(k) clearance process: Balancing patient safety and innovation. Washington, DC: National Academies Press.
- Yin, R. K. (2013). Case study research: design and methods. Thousand Oaks, CA: Sage Publications.
- Zuckerman, D. M., Brown, P., & Das, A. (2014). Lack of publicly available scientific evidence on the safety and effectiveness of implanted medical devices. JAMA Intern Med, 174(11), 1781–1787.
- Zuckerman, D. M., Brown, P., & Nissen, S. E. (2011). Medical device recalls and the FDA approval process. Archives of Internal Medicine, 171(11), 1006–1011.