The Paragard copper IUD has generated over 54,000 adverse event reports to the FDA since its approval in 1984, with nearly 24,000 of those classified as serious health problems — and the manufacturer has been accused of downplaying breakage risks that left thousands of women requiring invasive surgery. The T-shaped copper device, originally made by Teva Pharmaceuticals and now sold by CooperSurgical, can fracture during removal, leaving copper fragments embedded in the uterus or migrating to other organs. When the FDA inspected CooperSurgical’s manufacturing plant near Buffalo, New York in 2022, inspectors faulted the company for failing to adequately investigate breakage complaints and not implementing adequate corrective and preventive plans.
For readers of a brain health and dementia care site, this story matters more than it might first appear. Chronic pain, surgical trauma, infections including sepsis, and prolonged stress from unresolved medical device injuries all carry documented consequences for cognitive health and neurological well-being. The intersection of reproductive health complications and long-term brain health is an underexplored area, and the Paragard litigation — now involving roughly 3,926 federal lawsuits — highlights how systemic failures in medical device oversight can cascade into broader health consequences. This article examines what went wrong with Paragard reporting, what the FDA found, where the litigation stands as of early 2026, and what affected individuals should know.
Table of Contents
- Why Did the Paragard IUD Cause More Complications Than Doctors Reported?
- What the FDA Found When It Finally Investigated Paragard Breakage
- The Human Cost — Injuries That Go Beyond the Initial Breakage
- What Women With Paragard Should Actually Do Now
- The Cognitive and Neurological Dimension of Chronic Medical Device Complications
- How Medical Device Reporting Failures Affect Public Health More Broadly
- What Comes Next in the Paragard Litigation and What It Means for Patients
- Conclusion
- Frequently Asked Questions
Why Did the Paragard IUD Cause More Complications Than Doctors Reported?
The core problem is mechanical: one or both arms of the T-shaped copper device can snap off during routine removal. When that happens, copper fragments may remain lodged in the uterine wall or migrate to surrounding organs, leading to uterine perforation, organ damage, infections, infertility, and ectopic pregnancy. The FDA notes that approximately half of pregnancies occurring with an IUD in place are likely ectopic — a life-threatening condition requiring emergency treatment. Since 2009 through October 2025, the agency received 9,618 reports of device breakage alone, with nearly 6,000 of those classified as serious events. Twenty-two deaths have been linked to the device through the second half of 2025. The gap between what doctors told patients and what was actually happening grew wider over years.
Lawsuits allege that manufacturers failed to warn both patients and physicians about the risk of breakage during removal. When investigative journalists from Spotlight on America interviewed women who experienced Paragard breakage, none of them reported being warned about breakage risk beforehand. This is not a case where complications were rare and unpredictable — the adverse event data had been accumulating for years, and the manufacturer’s own complaint records showed a pattern that the FDA would later describe as showing “significant increases” in breakage reports. The reporting gap also reflects a structural problem in medical device surveillance. Adverse event reporting to the FDA is largely voluntary for physicians, and many complications go unreported entirely. The more than 7,000 breakage complaints on file likely represent a fraction of actual incidents. When the only systematic tracking depends on voluntary reporting by busy clinicians — many of whom may not connect a difficult IUD removal to a manufacturing defect — the true scope of a problem can remain hidden for years.
What the FDA Found When It Finally Investigated Paragard Breakage
In 2021, after a surge in adverse event reports, the FDA initiated a formal safety review of IUD breakage. The following year, the agency inspected CooperSurgical’s manufacturing facility in the Buffalo, New York area. The inspection report was damning: the FDA faulted CooperSurgical for failing to adequately investigate breakage complaints and for not implementing adequate corrective action and preventive plans. In plain terms, the company was receiving complaints about its device breaking inside women’s bodies and was not doing enough to figure out why or to prevent it from continuing. CooperSurgical pushed back. The company claimed there was “no significant increase” in breakage reports as a percentage of total problems reported.
The FDA disagreed, citing significant increases in breakage reports over several years. CooperSurgical also attempted to explain away the rising numbers by blaming “stimulated reporting” driven by lawsuits — essentially arguing that more women were filing complaints only because they had heard about litigation, not because more devices were actually breaking. The FDA rejected this explanation as well. However, it is important to note that a rising complaint count does not automatically prove the device became more dangerous over time. Changes in awareness, social media discussion, and legal advertising can genuinely increase reporting rates for a problem that existed all along. The critical issue is not whether reporting was stimulated but whether the underlying breakage risk was adequately disclosed to patients and doctors in the first place — and on that question, the evidence strongly suggests it was not. If CooperSurgical had been transparent about breakage rates from the beginning, the “stimulated reporting” argument would be irrelevant because patients would have already known the risk.
The Human Cost — Injuries That Go Beyond the Initial Breakage
When a Paragard device fractures during removal, the immediate crisis is only the beginning. Women have reported needing hysteroscopy, laparoscopy, or even full hysterectomy to retrieve broken fragments. These are not minor procedures — a hysterectomy permanently ends a woman’s ability to bear children and carries its own surgical risks including infection, blood loss, and damage to surrounding organs. For younger women who had chosen an IUD specifically to preserve future fertility, the outcome is a cruel inversion of the device’s purpose. The range of reported injuries extends well beyond the reproductive system. Uterine perforation can allow copper fragments to migrate into the abdominal cavity, potentially damaging the bladder, bowel, or other organs.
Infections from retained fragments can escalate to sepsis, a systemic inflammatory response that carries significant mortality risk and, in survivors, has been linked to long-term cognitive impairment. Research published in critical care medicine journals has documented that sepsis survivors frequently experience lasting deficits in memory, attention, and executive function — a connection that makes Paragard complications relevant to anyone concerned about brain health. One plaintiff in the federal litigation, Pauline Rickard, became the first bellwether case to go to trial. Her case against Teva began on January 20, 2026, and after a two-week trial resulted in a defense verdict — the jury found Teva not liable for failure to warn. That outcome was a blow to the thousands of pending cases, but it represents one jury’s assessment of one plaintiff’s specific facts. Bellwether trials are designed to test how juries respond to different case theories, and two more trials are scheduled: Alisa Robere’s case began March 3, 2026, and Melody Braxton’s trial is set for May 11, 2026. The outcomes of those trials will likely shape the trajectory of the entire litigation.
What Women With Paragard Should Actually Do Now
If you currently have a Paragard IUD and are considering removal, the most important step is to have a frank conversation with your gynecologist about breakage risk before the procedure. Ask specifically about the protocol if the device does not come out intact. A physician experienced with IUD removals should be prepared to use ultrasound guidance and should have a plan for imaging and possible surgical retrieval if fragments remain. Do not assume your doctor is already aware of the breakage issue — as the Spotlight on America investigation revealed, many clinicians were not adequately informed by the manufacturer. The tradeoff women face is real. Paragard remains the only non-hormonal IUD available in the United States, and for women who cannot or prefer not to use hormonal contraception, it fills a gap that no other long-acting device currently occupies.
Removing a functioning Paragard out of fear carries its own consequences, including the need to find alternative contraception and the very breakage risk that removal is meant to avoid. Women who are not experiencing symptoms and whose device has been in place for a shorter duration may face lower breakage risk than those with older devices, though the manufacturer has not provided clear data on how age of the device correlates with fracture rates. This is a decision that should be made with a trusted physician who is genuinely informed about the current data — not one who dismisses the concern. For women who have already experienced a Paragard breakage, documenting everything is critical. Medical records of the removal attempt, imaging showing retained fragments, surgical reports, and any communications with the manufacturer should be preserved. The federal MDL in the Northern District of Georgia is still accepting cases, and estimated individual settlement values — if a global settlement is eventually reached — range from $10,000 to over $400,000 depending on injury severity. However, no global settlement has been reached as of March 2026, and the defense verdict in the first bellwether trial has introduced significant uncertainty about how these cases will ultimately resolve.
The Cognitive and Neurological Dimension of Chronic Medical Device Complications
This is where the Paragard story intersects most directly with brain health. Chronic pain from retained device fragments, the psychological trauma of surgical complications, and the stress of prolonged litigation all take measurable tolls on cognitive function. The hypothalamic-pituitary-adrenal axis — the body’s central stress response system — was not designed for years of unresolved medical crisis, and sustained cortisol elevation is one of the most well-documented risk factors for hippocampal atrophy and memory impairment. Women who develop infections from retained Paragard fragments face additional neurological risk. Sepsis, even when survived, has been associated with accelerated cognitive decline in longitudinal studies.
A 2010 study in the Journal of the American Medical Association found that severe sepsis was associated with a substantially higher likelihood of moderate to severe cognitive impairment among older adults. While most Paragard users are younger, the principle holds: systemic infection creates neuroinflammation that can have lasting effects on brain structure and function. There is a limitation worth stating plainly: no large-scale study has specifically examined the long-term cognitive outcomes of women who experienced Paragard breakage complications. The connection between device-related injury, infection, chronic stress, and brain health is supported by the broader medical literature on each of those individual factors, but direct causation specific to Paragard has not been established. This is an area where more research is needed, and affected women should be aware that their experiences may carry cognitive health implications that their treating physicians have not considered.
How Medical Device Reporting Failures Affect Public Health More Broadly
The Paragard case is not an isolated failure. The FDA’s adverse event reporting system, known as MAUDE, depends heavily on voluntary submissions from healthcare providers, and systematic underreporting is a recognized problem across virtually all medical device categories. A 2017 study estimated that only a fraction of device-related adverse events are ever reported to the FDA, meaning the 54,000 reports filed for Paragard likely represent the visible portion of a much larger problem.
This matters for anyone navigating the healthcare system, particularly older adults managing multiple devices and medications. The lesson from Paragard is not that all medical devices are dangerous — it is that patients cannot rely solely on manufacturer disclosures or even FDA-cleared labeling to understand the full risk profile of a device. Asking physicians directly about adverse event data, checking the FDA’s MAUDE database independently, and seeking second opinions before elective device procedures are reasonable precautions that the Paragard experience validates.
What Comes Next in the Paragard Litigation and What It Means for Patients
The trajectory of the Paragard litigation over the next several months will be shaped largely by the second and third bellwether trials. If plaintiffs secure favorable verdicts in the Robere or Braxton cases, pressure on CooperSurgical and Teva to negotiate a global settlement will increase substantially. If the defense continues to prevail, individual plaintiffs may face difficult decisions about whether to continue pursuing their claims.
The roughly 3,926 cases pending in the federal MDL represent a significant volume, and resolving them through individual trials would take years. For the broader medical device landscape, the Paragard litigation has already produced one lasting change: greater scrutiny of how manufacturers respond to breakage and fracture complaints. The FDA’s rejection of CooperSurgical’s “stimulated reporting” defense sends a signal that the agency expects manufacturers to investigate complaint trends on their merits rather than dismissing them as litigation artifacts. Whether that signal translates into stronger regulatory action or remains a one-off inspection finding will depend on how aggressively the FDA follows up — and on whether Congress provides the agency with the resources and authority to hold manufacturers accountable before tens of thousands of adverse events accumulate.
Conclusion
The Paragard IUD story is fundamentally one of information failure. A device that could fracture inside the body was implanted in millions of women without adequate disclosure of that risk, the manufacturer disputed the significance of its own complaint data, and the FDA did not act decisively until years after breakage reports began climbing. The consequences for affected women have ranged from additional surgery to infertility to life-threatening infections, and the potential cognitive and neurological effects of these complications deserve far more attention than they have received. With no global settlement on the horizon and bellwether trials still underway, the legal resolution remains uncertain.
For readers concerned about brain health, the Paragard case offers a broader reminder: medical device complications do not stay contained within a single organ system. Chronic pain, infection, surgical trauma, and sustained psychological stress all have documented pathways to cognitive impairment. Staying informed about the devices in your body, advocating for complete risk disclosure from your physicians, and documenting any complications thoroughly are practical steps that apply far beyond this single product. The women affected by Paragard breakage deserved better information before it happened — the least we can do now is ensure the information that has finally emerged reaches the people who need it.
Frequently Asked Questions
What is the Paragard IUD made of and why does it break?
Paragard is a T-shaped copper intrauterine device. The arms of the T can snap off during removal, particularly in devices that have been in place for extended periods. The exact manufacturing factors contributing to breakage have been the subject of FDA investigation, with inspectors faulting CooperSurgical for inadequate complaint investigation.
How many adverse events have been reported to the FDA for Paragard?
Over 54,000 adverse event reports have been filed with the FDA since Paragard was approved in 1984. Nearly 24,000 of those were classified as serious, and 22 deaths have been linked to the device through the second half of 2025. From 2009 through October 2025, 9,618 reports specifically involved device breakage.
Has there been a Paragard settlement?
No global settlement has been reached as of March 2026. Approximately 3,926 lawsuits are pending in the federal multidistrict litigation in the Northern District of Georgia. The first bellwether trial resulted in a defense verdict for Teva in early 2026, and two additional bellwether trials are scheduled. Estimated individual settlement values, if a resolution is reached, range from $10,000 to over $400,000.
Can Paragard complications affect brain health?
While no study has specifically examined Paragard breakage and cognitive outcomes, the complications associated with the device — including sepsis, chronic pain, and prolonged psychological stress — are all independently associated with cognitive impairment and accelerated brain aging in the medical literature.
Should I have my Paragard removed?
This is a decision to make with your gynecologist based on your individual circumstances. If you choose removal, discuss breakage risk beforehand and ensure your physician has a plan for imaging and possible surgical retrieval if the device does not come out intact. Paragard remains the only non-hormonal IUD available in the U.S., so weigh the breakage risk against your contraceptive needs and alternatives.
Were doctors warned about Paragard breakage risk?
Lawsuits allege that manufacturers failed to adequately warn both patients and physicians. Among women who reported breakage to investigative journalists at Spotlight on America, none said they had been warned about breakage risk before it occurred.
