The medical device industry plays an essential role in modern healthcare. It offers tools and technologies that improve quality of life and support critical treatments. 

According to Market.us, the worldwide medical devices market was worth USD 492 billion in 2022. It is projected to reach USD 656 billion by 2032, reflecting a steady compound annual growth rate (CAGR) of 3%. This growth is largely driven by the rise in complex surgeries and advancements in technology.

However, alongside innovation comes the risk of malfunction, and women have been disproportionately affected by certain medical device failures. From reproductive health aids to implants and monitoring systems, several devices have sparked concern due to unexpected complications. 

This article explores five medical device failures that caught women off guard, shedding light on the real-world impact behind the statistics.

1. Paragard IUD

The Paragard intrauterine device (IUD) has long been marketed as a safe, hormone-free contraceptive option, effective for up to ten years. However, in recent years, alarming reports have surfaced of the device breaking during removal, leading to severe injuries and unexpected medical interventions.

Reports have emerged of the device breaking during removal, particularly the copper arms snapping off and becoming lodged in the uterus. These incidents have led to severe medical outcomes such as internal bleeding, chronic pain, infections, and in some cases, hysterectomy. Additional complications include device migration, tissue damage, and potential infertility.

The situation has led to thousands of legal claims, with over 3,200 lawsuits currently pending in court as part of the ongoing Paragard lawsuit. Plaintiffs allege defective design and a failure to adequately warn users of the risks.

According to TorHoerman Law, the FDA has initiated a safety review following more than 7,000 complaints submitted to its Adverse Event Reporting System. These unexpected complications have left many women physically and emotionally distressed, eroding trust in what was marketed as a reliable medical device.

2. Essure Permanent Birth Control

Essure, a permanent birth control device, was initially promoted as a non-surgical alternative to traditional tubal ligation. The device involved placing small metal coils into the fallopian tubes, which would then trigger scar tissue formation to block the passage of eggs. 

While designed to offer a convenient, long-term solution for contraception, Essure has instead caused widespread controversy and health concerns. Thousands of women reported severe complications, such as chronic pelvic pain, device migration, and even perforation of the uterus or fallopian tubes. 

In many cases, women had to undergo additional surgeries, some as drastic as hysterectomies, to remove the device. These adverse effects have led to lasting physical and emotional trauma.

The FDA searched the MAUDE database on January 2, 2025. The search identified 73,678 medical device reports related to Essure from its approval in 2002 through December 2024. Most early reports (2013–2015) were submitted by patients, but by 2024, Bayer, the device’s manufacturer, submitted 98% of the reports. Mounting safety concerns and public outcry eventually led to Essure being discontinued in the U.S.

3. Transvaginal Mesh

Transvaginal mesh was introduced as a surgical solution for pelvic organ prolapse (POP) and stress urinary incontinence (SUI), both common conditions following childbirth. The mesh was designed to reinforce weakened pelvic muscles and provide long-term support. However, over time, alarming reports emerged about serious complications.

Many women suffered from mesh erosion, chronic pelvic pain, recurrent infections, and in severe cases, organ perforation. Removal often proved difficult, as the mesh could become embedded in surrounding tissue. These complications frequently led to additional surgeries, sometimes multiple, which brought lasting physical and emotional distress. 

According to the NIH, long-term outcomes are worse than originally reported. Studies suggest that 1 in 30 women may require a second procedure to remove or revise the mesh up to a decade after implantation. These complications are frequently underreported and underestimated by healthcare providers and patients alike, making awareness and proper follow-up essential.

4. Breast Implants

Breast implants, whether silicone or saline, have long been used for cosmetic and reconstructive purposes. However, beyond the commonly known risks of rupture and capsular contracture, more serious health concerns have emerged. 

A rare form of cancer, breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), has been linked primarily to textured implants. Additionally, a growing number of women have reported systemic symptoms collectively referred to as “breast implant illness.” These symptoms include fatigue, joint pain, cognitive difficulties, and autoimmune issues.

These unexpected complications have prompted increased regulatory scrutiny and product recalls. Many women, unaware of the potential long-term risks, were caught off guard after years of assuming their implants were safe. 

In response, the FDA now mandates that all approved breast implants include clear, patient-friendly labeling. This includes a patient decision checklist, boxed warnings highlighting key risks, and a device card with implant-specific information. The sale and distribution of breast implants are restricted to healthcare providers who ensure patients review and sign this checklist prior to surgery.

5. Metal-on-Metal Hip Implants

Metal-on-metal hip implants were once promoted as a durable solution for individuals needing joint replacement due to arthritis or injury. Though commonly associated with older adults, many women also received these implants. 

However, significant complications emerged over time. The friction between metal components can release metal ions into the bloodstream, leading to metallosis—a form of metal poisoning. This condition may cause tissue damage, chronic pain, inflammation, and ultimately implant failure.

Women have shown higher rates of adverse effects, which may be attributed to anatomical differences and variations in immune system responses. As a result, many patients required painful and costly revision surgeries. In some cases, the health impacts have been long-lasting and severe. 

The widespread nature of these issues prompted product recalls and a surge of lawsuits against manufacturers. The controversy highlighted the need for better testing, transparency, and patient education regarding the risks of implanted medical devices, especially for women.

Frequently Asked Questions (FAQs)

How can women make safer choices about medical devices?

Women can make safer choices by researching thoroughly, consulting multiple medical professionals, reviewing FDA safety alerts, and asking about long-term risks. Understanding manufacturer warnings and patient experiences can also provide insight. Participating in shared decision-making with a healthcare provider ensures informed, personalized medical choices.

What should I do if I suspect my medical device has failed?

If you suspect your medical device has failed, seek medical attention immediately. Document symptoms, keep the device packaging or information, and report the issue to the FDA’s MedWatch. Consult your doctor for further evaluation, and consider speaking with a legal expert if the failure caused serious harm or complications.

Do medical devices expire?

Yes, medical devices can expire. Many have a shelf life or expiration date, especially those with sterile packaging or electronic components. Using expired devices can lead to reduced effectiveness or safety risks. Always check the manufacturer’s label and consult a healthcare provider before using any medical device.

Medical device failures have left countless women facing unexpected pain, surgeries, and life-altering health challenges. The cases highlight the urgent need for better oversight, transparency, and patient education. Women must be empowered to ask questions, report adverse events, and advocate for their health. As the medical device industry evolves, learning from these failures is essential to prevent future harm.

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