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Medical Device, Recall & Approval Process: Study Recommends Stricter FDA Regulation

Terri Ackerman

Last updated: October 20, 2016 7:03 pm

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A recent study suggests that stricter U.S. Food and Drug Administration (FDA) regulations, sufficient “proper data,” and greater FDA oversight could prevent some serious medical device problems. Specifically, problems with some medical devices might have been prevented if the FDA had required more rigorous testing and comprehensive expert evaluation. 1

According to the study, published in the journal Obstetrics and Gynecology, some in the medical community are concerned about the approval process for certain “high-risk” devices used in obstetrics and gynecology. The researchers reviewed the FDA medical device approval database for approvals granted from January 2000 to December 2015. They concluded that the FDA may have been too hasty in approving or not sufficiently diligent in requiring efficacy and safety data. It is important for the FDA to hold companies to a high scientific standard for trials for medical devices used in obstetrics and gynecology. 2

Controversial devices discussed in the study include a permanent sterilization method for women and a device intended to reduce postsurgical adhesions. 3

The researchers also raised concerns about some devices that went through the short 501(k) approval process as an equivalent to a medical device already on the market, including transvaginal mesh and power morcellators.  These devices were approved through the 510(k) approval process instead of the more rigorous premarket approval process for new medical devices. The use of these devices and reports of postmarketing adverse events have led to serious health concerns. The largest manufacturer of power morcellators withdrew their power morcellators from the market, and transvaginal mesh has subsequently been reclassified by the FDA as a PMA, “high-risk” device. 4

On one hand, the researchers acknowledge the desire to not discourage medical device “innovation.” On the other hand, they believe that raising the “burden of proof” related to device safety might reduce the number of patient adverse events and complications and medical device recalls. 5

FDA Classifies Medical Devices

When the FDA approves a medical device, it also officially classifies that device based on how potentially dangerous it appears to be. Class I devices are considered fairly safe and do not require extensive testing before being approved, while Class III devices ostensibly require more rigorous and comprehensive testing for approval. 6

Class I devices are understood to carry the least danger. Examples include bandages and tongue depressors. 7

Class II devices are deemed of potentially moderate risks to patients. Examples include hip implants and catheters. These devices are approved through what is known as the 510(k) approval pathway, which “allows applicants to cite similar existing and previously approved devices as predicates, which circumvents the need for additional clinical testing or postmarketing surveillance.” 8

Class III devices are “designated life sustaining,” and present the greatest potential risks to patients. Examples include pacemakers and breast implants. 9

Problems with Medical Devices

While some defective medical devices may be recalled either voluntarily or by the FDA, there are others that are not recalled. Despite the lack of a recall, or a limited recall of only a few specific models, serious medical problems may arise as a result of using these devices.

This concern over the potential side effects of using certain devices has become apparent, most recently with two devices used in gynecological procedures: transvaginal mesh and power morcellators.

Although they have had limited recalls, if any, the FDA has serious safety concerns about the use of both of them. 10

Vaginal Mesh, Recalls and Warnings

In 2011, the FDA released a Safety Communication, not recall, regarding transvaginal mesh. The agency concluded that it did not see “conclusive evidence that using transvaginally placed mesh in POP [pelvic organ prolapse] repair improves clinical outcomes any more than traditional POP repair that does not use mesh, and it may expose patients to greater risk.” 11

In 2012, the Ethicon division of Johnson & Johnson withdrew four transvaginal mesh models citing market concerns, rather than medical ones. 12

In January 2016, the FDA announced two final orders regarding surgical mesh used for pelvic organ prolapse: one to reclassify these devices from Class II, moderate-risk devices to Class III, high-risk devices and a second, requiring manufacturers to “submit a premarket approval (PMA) application to support the safety and effectiveness of surgical mesh for the transvaginal repair of POP.” 13

No Power Morcellator Recall to Date

In 2014, the FDA issued not a power morcellator recall, but a Safety Communication about use of these devices in laparoscopic gynecologic surgery. During surgery, the devices can scatter bits of undetected cancerous tissue throughout the abdominal cavity. 14

Power morcellators have been used in laparoscopic surgery to removed fibroids (called a myomectomy) or a woman’s uterus (known as a hysterectomy). This medical device slices up tissue into tiny bits and then removes them through small incisions in the abdomen. 15

Power morcellators can spread uterine sarcomas, including an aggressive type of cancer called leiomyosarcoma. “Because of this risk and the availability of alternative surgical options for most women, the FDA” has warned “against the use of laparoscopic power morcellators in the majority of women undergoing myomectomy or hysterectomy for treatment of fibroids.” 16

  1. http://www.ncbi.nlm.nih.gov/pubmed/27159747http://www.fiercemedicaldevices.com/story/fda-approved-high-risk-womens-health-devices-without-proper-data-study/2016-05-23 

  2. http://www.ncbi.nlm.nih.gov/pubmed/27159747; http://www.fiercemedicaldevices.com/story/fda-approved-high-risk-womens-health-devices-without-proper-data-study/2016-05-23 

  3. http://www.ncbi.nlm.nih.gov/pubmed/27159747; http://www.fiercemedicaldevices.com/story/fda-approved-high-risk-womens-health-devices-without-proper-data-study/2016-05-23 

  4. http://www.ncbi.nlm.nih.gov/pubmed/27159747; http://www.fiercemedicaldevices.com/story/fda-approved-high-risk-womens-health-devices-without-proper-data-study/2016-05-23; http://cancerletter.com/articles/20140801_1/; http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm479732.htm 

  5. http://www.ncbi.nlm.nih.gov/pubmed/27159747; http://www.fiercemedicaldevices.com/story/fda-approved-high-risk-womens-health-devices-without-proper-data-study/2016-05-23 

  6. http://www.ncbi.nlm.nih.gov/pubmed/27159747 

  7. http://www.ncbi.nlm.nih.gov/pubmed/27159747 

  8. http://www.ncbi.nlm.nih.gov/pubmed/27159747 

  9. http://www.ncbi.nlm.nih.gov/pubmed/27159747; http://www.fda.gov/MedicalDevices/ResourcesforYou/Consumers/ucm142523.htm 

  10. http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm424443.htm; http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm479732.htm; http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm262435.htm 

  11. http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm262435.htm; http://www.fda.gov/downloads/MedicalDevices/Safety/AlertsandNotices/UCM262760.pdf 

  12. http://www.nytimes.com/2012/06/06/business/johnson-johnson-unit-will-stop-selling-urinary-implants.html?_r=0 

  13. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm479732.htm 

  14. http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm424443.htm 

  15. http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm424443.htm 

  16. http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm424443.htm