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Regulation of Low to Moderate Risk Medical Devices by the Food and Drug Administration

By: Hayeon Na, Co-Copy Editor [Content-Focused]

On March 22, 2013, Public Broadcasting Service (PBS) aired an episode of “Need to Know” on the safety of low to moderate risk medical devices. The episode closely followed the lawsuit of patient Linda Gross who has pelvic organ prolapse and was advised by her doctor to undergo a minimally invasive procedure that places a mesh implant called Prolift ® in her pelvic area. Gynecare Prolift® is made by Ethicon, a subsidiary of Johnson and Johnson. Before the implant surgery, Gross was told that the mesh could be removed if there were immune rejections; however, she later found out that this was not the case.

Gross had Prolift® implanted in July of 2006.1 The surgery was successful, but she suffered from incessant sharp pains that disabled her from carrying out simple tasks. “Need to Know” informs that Gross decided to have the mesh removed 5 months later, but the doctor was unable to remove the whole mesh because her tissues had already grown into the device. She had multiple surgeries in which parts of the mesh were “cut out like bubblegum in your hair.”7 In total, Gross had 22 surgeries that involved Prolift®. She is no longer able to have sexual intercourse with her husband Jeff Gross, and suffers from pain that can only be controlled with narcotic pain medication.7

Linda and Jeff Gross attempted to contact Ethicon but did not receive a response. The Grosses hired attorney Adam Slater who sued Ethicon and Johnson and Johnson on their “failure to warn” consumers. Linda Gross was awarded $11.1million—$7.76 million in punitive damage and $3.35 million in compensatory damage— on February 25, 2013. In response, Ethicon issued a statement that it would appeal the verdict. There are thousands of other cases brought against Ethicon and other trans-vaginal mesh manufacturers, and “Need to Know” questioned whether the Food and Drug administration (FDA) approval process for low-to-moderate risk medical devices was adequate to ensure the safety of consumers, and whether the process was even being followed.

Prolift® was introduced in 2005 without being cleared by the FDA. Ethicon’sProlift® website states that over 120,000 women have received Prolift® implantations since 2005, when the device was marketed without FDA clearance. According to Bloomberg, the FDA warned Johnson and Johnson that the device had a “potential high risk for organ perforation” in August 2007. 2

“You may not market this device until you have provided adequate information,” …the agency told the New Jersey-based company… “If you market the device without conforming to these requirements, you will be in violation of the Federal Food, Drug and Cosmetic Act.” 2

The FDA published an adverse event report on May 1st, 2008 that stated that a patient’s Prolift® “crumpling into a ball” inside her body and caused her to have “jabbing pains” which led to a hysterectomy two months later. The result of this case report was “inconclusive”3 and Prolift®’s sale was not suspended. On the contrary, Prolift® was approved on May 15, 2008 on the grounds of being substantially equivalent to Gynemesh®, a product which was approved in 2004.4 In June 2012, Johnson and Johnson discontinued Prolift® for profit reasons after lawsuits were filed against the product.6

      In August 2010, “Vaginal Mesh for Prolapse: A Randomized Controlled Trial Study” by Iglesia, et al. was published in Obstetrics & Gynecology. The study was conducted for 3 months and involved 65 women who had organ prolapse.  The conclusion of the study was that the difference in “objective and subjective cure rates” between the group that had Prolift® and the group that did not was insignificant, but the mesh group had a higher rate of complications such as “vaginal mesh erosion.”5

Some medical devices and medications pose a challenge when it comes to clinical trials, which makes it difficult to determine the safety and efficacy.  Gregory Curfman, the executive editor of the New England Journal of Medicine, says that the current clearance process of proving “substantial equivalence” to an existing device that is marketed “does nothing to ensure the safety and the effectiveness of the device.”7 He believes that a more thorough review process of medical devices is needed.

David Nexon, the Senior Executive Vice President of Advamed—a trade association that represents medical device manufacturers—says that the process in place allows “innova[tion] much more rapidly.”7 However, problems arise when the old, proven devices are recalled after generations of new devices are approved by proving substantial equivalence.  Much like how the JengaTM tower fall when the lower blocks are removed, when too many of the older devices are recalled, the safety of newer devices that were approved upon the older devices is brought into question.

“For instance, Johnson and Johnson’s pelvic mesh traces its lineage back to various mesh products dating back decades. But one of those products was recalled in 1999.” After reports of injuries, Curfman says examples like this show why a more thorough review process of medical devices is needed. 7 (p4)

It takes more time and capital to bring innovation into play when every new device has to be built from the ground up; however, it is also impossible to ensure the safety of a device without thorough review involving clinical trials. This poses a burden on the manufacturers to invest millions of dollars in research and development, which may suppress competition.

The FDA commissioned a report from independent medical experts about its clearance process for low to moderate risk devices [in July 2011]. The experts concluded that the process was ‘flawed’ and recommended that the FDA come up with an entirely ‘new framework.’ Despite the findings, the FDA later issued a response [that the] clearance process should ‘not be eliminated.’7 (p5)

Even though both safety and innovation are important in the making of new products, many consider that the two are at odds with each other.  In the show, Host Jeff Greenfield asked Josh Rising, Project Director of the Medical Device Initiative at the Pew Charitable Trusts, how the United States compares to other countries in regards to medical device safety, and how post-market surveillance could be improved. According to Rising, post-marketing surveillance is the answer to both fostering innovation and ensuring safety. In Australia, there has been a registry for the past 10-12 years that tracks Australians who has received hip or knee replacements. This enables a real-time update on adverse effects and thus a faster reaction by medical personnel. Due to this system, doctors in “Australia stopped using metal-on-metal hip replacements years before those in [the United States].”7 (p7)

Rising also stated that medical devices need a unique ID to track the devices to not only to more efficiently alert manufacturers of a problem but also to inform consumers about a recall issued or an adverse effect discovered. Rising asserts that devices are “one of virtually the only consumer products that don’t have a unique number.”7 (p8) Currently, only the clinicians are in charge of informing patients of a complication. Therefore, if the clinician retires, loses track of the patient, or passes away, he or she can no longer inform the consumers.  Once in place, the unique device ID system would also benefit the manufacturers because they can collect data and use it to improve their next products.

In the US, Medwatch and NHRIC can be compared to a registry and unique ID number. Medwatch was founded in 1993 as FDA’s adverse event reporting system concerning medical products. Reports are voluntary for the general public and health care professionals and mandatory for manufacturers, importers, and medical product user facilities that manage and store medical products.8 However, there is no registry that keeps track of individual patients who are using individual devices.

The FDA has set aside a set of numbers in the 1970s for National Health Related Items Code (NHRIC), a system for identification and numbering of marketed device packages.9 This is voluntary, and manufacturers who desire to use the NHRIC number for unique product identification may apply to FDA for a labeler code.10 The labeler code of Ethicon Inc. is 8135, assigned in February of 1970.11 The NHRIC of Prolift® could not be easily located upon research.

In “Need to Know,” NHRIC and Medwatch were not mentioned by Rising. If NHRIC was used judiciously, it may be useful in improving post-marketing surveillance. However, simply improving post-marketing surveillance without stricter FDA requirements would make some consumers “test subjects” for low to moderate-risk devices. Both post-marketing surveillance, which keeps track of patients who use the device, and FDA regulation, which involves tightening the standards for new devices before they go on market, need to be reconsidered. This process is surely to involve patients, clinicians, the FDA, and the manufacturers.

More patients benefit from innovation as new devices come onto the market; at the same time, patients risk unknown adverse effects with newer medical products. When health professionals recommend new treatments, patients should not submit to “therapeutic misconception,” or assume that the product is safe and efficacious. Instead, patients and clinicians should make medical procedures an active process by actively researching the products before use and by providing following-up services.

If all of these measures were implemented, there would surely be a decrease in the sale of defective products and the incidence of serious adverse effects, which would result in fewer lawsuits and less health resources lost on the repetitive litigations that involve medical products. After researching their options, more prudent consumers will demand the manufacturers design products that are safer and more efficacious, even without stricter FDA regulations. Since the need for stricter regulation for low to moderate risk medical devices will diminish, this will prevent the ballooning of government healthcare costs. Not only should there be no mistakes made by the FDA and the manufacturers, but the consumers and the clinicians should also scrutinize products beforehand to create more opportunities to catch mistakes.

It is unfortunate that so many patients suffered from disabling adverse effects and my deepest condolences go out to those who suffer. Tragedy like this should not go on; this is an opportunity to involve everyone to better the health care system. Along with a better use for NHRIC and Medwatch, having all parties informed, involved, and working together in the health care system instead of pointing fingers or blaming only one sector will help achieve what everybody desires—safer, more efficacious products at lower costs.


  1. Akre J. Day 14: Linda Gross v. Ethicon, Ms. Gross Takes the Stand. Mesh Medical Device Newsdesk. http://meshmedicaldevicenewsdesk.com/latest-in-the-litigation-concerning-mesh-and-medical-devices/day-14-linda-gross-v-ethicon-she-takes-the-stand/. Published January 31, 2013. Accessed March 22, 2013.
  2. Voreacos D, Nussbaum A. J&J Sold Vaginal Mesh Implant After Sales Halt Ordered. Bloomberg. http://www.bloomberg.com/news/2012-06-26/j-j-sold-vaginal-mesh-implant-after-sales-halt-ordered.html . Published June 26, 2012. Accessed March 23, 2013.
  3. U.S. Food and Drug Administration. MAUDE Adverse Event Report: ETHICON, INC.PROLIFT®  PELVIC FLOOR REPAIRMESH, SURGICAL, POLYMERIC. U.S. Food and Drug Administration. http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1095383. Published May 1, 2008. Accessed March 23, 2013.
  4. U.S. Food and Drug Administration. Summary of Safety and Effectiveness K071512. U.S. Food and Drug Administration Access Data. http://www.accessdata.fda.gov/cdrh_docs/pdf7/K071512.pdf. Published May 15, 2008. Accessed March 23, 2013.
  5. Iglesia CB, Sokol AI, Sokol ER, et al. Vaginal mesh for prolapse: a randomized controlled trial. Obstet Gynecol. 2010;116: 293–303.
  6. Drugwatch. Transvaginal Mesh Recall. Drugwatch. http://www.drugwatch.com/transvaginal-mesh/recall.php. Published Feb 27, 2013. Accessed March 23, 2013.
  7. Public Broadcasting Service. Transcript: March 22, 2013. Public Broadcasting Service. http://www.pbs.org/wnet/need-to-know/transcripts-full-episode/transcript-march-22-2013/16591/. Published March 22, 2013. Accessed March 23, 2013.
  8. Craigle V. MedWatch: The FDA Safety Information and Adverse Event Reporting Program. J Med Libr Assoc. 2007 April; 95(2): 224–225.
  9. U.S. Food and Drug Administration. Medical Devices. U.S. Food and Drug Administration. http://www.fda.gov/medicaldevices/deviceregulationandguidance/databases/default.htm. Published Mar 5, 2013. Accessed March 23, 2013.
  10. U.S. Food and Drug Administration. More about National Health Related Items Code – NHRIC. U.S. Food and Drug Administration. http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Databases/ucm161456.htm. Published Aug 31, 2009. Accessed March 23, 2013.
  11. U.S. Food and Drug Administration. NHRIC – National Health Related Items Code. U.S. Food and Drug Administration. http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfNHRIC/nhric.cfm?ID=136. Published Mar 1, 2013. Accessed March 23, 2013.
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