These 2 medical devices have sparked controversy

Sandra Maddock, president, IMARC Research

The history of clinical research is filled with unfortunate examples of drug and device trials that involved serious ethical violations, injured patients or even resulted in death.

It’s a sobering reminder of the many risks medical devices can pose to patients and the importance of compliance in clinical trials. Although many of these events occurred decades ago, medical devices still have the potential to cause harm.

These issues are documented in the FDA’s annual list of medical device recalls and (in some rare cases) even make headlines. Here are two examples of more recent medical devices that have hurt patients.

Pelvic mesh treatments

Pelvic organ prolapse occurs when the tissue and muscles of the pelvic floor no longer support pelvic organs, causing them to drop. This can cause bulging, pain, urinary incontinence or sexual difficulties. Pelvic organ prolapse can be caused by childbirth or age.

Many physicians have used plastic surgical mesh to treat pelvic organ prolapse. However, the FDA has identified serious complications with the use of surgical mesh for this purpose. An FDA review of adverse events from 2005 to 2010 identified at least three deaths directly associated with pelvic mesh procedures (two bowel perforations and one hemorrhage), as well as nearly 4,000 reports of injury and malfunction. The most frequent complications included:

• Vaginal mesh erosion
• Infection
• Urinary problems
• Bleeding
• Organ perforation
• Recurrent prolapse
• Vaginal scarring

The FDA has not seen conclusive evidence that using transvaginal mesh in pelvic organ prolapse repairs improved outcomes more than traditional pelvic organ prolapse procedures, and it may expose patients to greater risk.

Complications from pelvic mesh treatments have resulted in a number of lawsuits.

In March 2018, the U.S. District Court for the Northern District of Indiana awarded one couple $35 million in damages after the woman suffered from severe pain and other injuries related to pelvic mesh treatment.

Pelvic mesh treatments are still in use today, although the FDA encourages healthcare providers to recognize that many instances of pelvic organ prolapse can be treated without mesh. Scientists have also developed a new mesh made of softer polyurethane material, although it still needs to undergo rigorous clinical trials before it will be approved.

The Essure birth control device

Bayer recently made the decision to discontinue the sale and distribution of Essure, a permanent, non-surgical birth control device implanted into the fallopian tubes, after a number of women reported painful complications.

In a news release, Bayer stated it stands by the product’s safety and efficacy, which it says is demonstrated by research involving more than 200,000 women over the past two decades. However, Bayer cited increased permanent contraception options, declining sales and “inaccurate and misleading publicity” among its reasons for discontinuing the device.

Since the FDA approved the device in 2002, it has received more than 26,770 reports of complications, including:

• Abdominal, pelvic or back pain
• Tearing or perforation of the uterus or fallopian tubes
• Unintended pregnancy
• Unexpected movement of the device to the abdominal or pelvic cavity
• Headaches
• Fatigue
• Weight changes
• Hair loss
• Mood changes, including depression

One patient’s painful experience with Essure led her on a crusade to warn others about the dangers of the device. She started a Facebook group called Essure Problems, which has more than 42,000 members to date and was featured in a recent Netflix documentary, The Bleeding Edge.

The importance of real-world evidence in medical device trials

Even the most well-controlled and rigorously conducted clinical study is limited in its ability to determine definitively how the device will function out in “the real world.” Limited by sample size, patient selection criteria, and the fact that there is a closer level of oversight and training of clinical personnel in a controlled clinical trial setting, clinical trials, while absolutely critical to the process, may not always be able to tell the full story. The serious complications these two medical devices have caused illustrate the importance of continuing to study the safety and efficacy of medical devices by collecting ample real-world evidence after regulatory approval.

When mesh products were initially introduced for pelvic repair in the 1990s, they were not required to undergo the FDA’s pre-market approval (PMA) process to demonstrate safety and effectiveness. In 2016, the FDA reclassified pelvic mesh as a high-risk medical device, and manufacturers are now required to submit premarket approval applications.

The Essure birth control device was always classified as a high-risk medical device and did undergo the pre-market approval process prior to its release. Following reports of adverse events, the FDA ordered the original manufacturer, Conceptus, and Bayer (the company that later acquired Conceptus) to conduct additional post-market studies.

Post-market data collection is important because long-term side effects may not always be evident during clinical trials. For this reason, the FDA has announced plans to increase post-market data collection and surveillance of medical devices.

IMARC Research has helped many medical device companies conduct compliant trials and ultimately secure approval. We also have extensive experience in collecting real-world evidence after a device has been approved.

To learn more about the history of clinical research and our role in it, explore our interactive timeline.

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