The history of birth control is unfortunately filled with unfortunate defects that have injured women. Dalkon Shield became one of the largest mass tort lawsuits of all time. IUD insertion had been viewed as an easy way for a reversible form of birth control that did not have the same hormonal effects.
However, intrauterine devices have proven dangerous, as IUD removal work does not always go as planned. A IUD device called Paragard was supposed to change that. However, the IUD removal process has often gone awry, causing women serious injury.
Paragard is made by a company called CooperSurgical Inc. The original manufacturer was Teva Pharmaceutical, but Teva sold the Paragard product line to Cooper for $1.1 billion in 2017. The product has been on the market since 1984.
At the time that Cooper bought Paragard, the product was doing $168 million in annual sales. Now, both of these companies are defendants in hundreds of medical device lawsuits filed by injured women. They put profits over the safety of the women to whom they sold the product.
For information on current litigation, visit our Paragard lawsuit web page.
How Paragard Prevents Pregnancy
In theory, Paragard looks to be a simple product that is an easy way to prevent pregnancy. It is a simple looking t shaped device, consisting of only a few parts. These are:
- a copper coil
- a plastic t shaped piece
- strings on each side of the plastic
There is a copper wire attached to the end of the plastic. The copper coil is what provides the actual birth control effect. It produces an inflammatory reaction that harms both the sperm and the egg.
The copper has a natural toxicity that keeps the sperm from fertilizing the egg and implanting on the uterine wall. This is how Paragard prevents pregnancy.
There are no hormonal effects, just something in the uterus (inserted through the cervix) that makes it an inhospitable environment and keeps women from getting pregnant.
Some women prefer an IUD device because they view birth control as dangerous drugs. Paragard offers them an IUD without hormonal effects (unlike the Mirena IUD), and it can keep women from needing emergency contraception.
The doctor will insert the device in an office visit. Many can even obtain this form of birth control from an organization such as Planned Parenthood. No surgery whatsoever is required.
The entire process in the health care provider’s office can be done in a few minutes. The doctor inserts the device easily through the cervical canal. Once Paragard is in place, it can begin to work immediately.
Why Paragard Needs Removal After a Period of Time
Paragard can only be effective inside the body for so long. After a certain period of time, the copper wiring will wear down, and the IUD will not work as well as it did. Paragard can work for up to ten years and remain effective.
The manufacturers and peer reviewed studies claim that it has an effective rate greater than 99%. However, nobody has questioned whether it works. Instead, people are questioning the product’s safety, since the manufacturer may have failed to account for what happens to the device when it is in the body for so long.
Women may also want to have the device removed when they want to get pregnant. Paragard should have no lasting effects when it is removed (assuming that pieces of it have not damaged the reproductive organs). They just need to remove the birth control before they want to try to get pregnant.
The IUD Strings Do Not Always Work as Intended
Removal can be done in a doctor’s office, and it is only supposed to take only a few minutes. According to the manufacturer, all the doctor is supposed to do is gently pull on the strings to remove Paragard.
The device is supposed to easily come out of the body without requiring surgery from a healthcare provider. Some doctors even say that it is safe for women to take Paragard out of their body on their own. In any event, the company never warned about any danger associated with removal until recently.
However, this rosy product description used by the manufacturer does not always square with reality. Remember that Paragard can be in the body for years. Besides wear-and-tear on the plastic, the body itself can cause the device to weaken.
Synthetic medical devices that are inside the human body may not hold up well over time. That is exactly what happens with Paragard. The strings and the plastic do not always remain intact when the doctor reaches into the vagina to remove it.
Cervical mucus can degrade the product over time, and it can come apart inside the body. In this case, it can be incredibly difficult to have the IUD removed, but the health care provider will not realize it until after they have tried.
Complications from IUD Removal
The major complications occur when the strings break apart from the plastic or the plastic device breaks apart inside the body. This can cause serious danger in both the short and long run.
Any medical device that frays and breaks apart will result in significant side effects. We have seen this already with hernia mesh and vaginal mesh.
Even tiny pieces of these synthetic materials loose inside the body can cause intense pain and may require surgery to remove. The problem can be even worse when the foreign object is a hard piece of plastic.
Plastic in the Uterine Cavity Can Cause Serious Danger
Even Paragard removal that goes according to plan can cause side effects. The most common difficulty is pain and light bleeding, but that goes away in a few minutes normally.
Most women will feel some discomfort during the procedure, even though it is minor. For most women, there are not any problems during device removal. However, others are less fortunate.
The doctor may know immediately that there has been a problem during the removal. When the strings break off, and the plastic is still in the body, it is an indicator of a problem.
However, the doctor may not always know immediately that small pieces of plastic have broken off the t shaped device attached to the copper IUD. The women may not even know until she starts feeling pain right after the procedure.
When there are complications in Paragard removal, women can suffer the following side effects:
- severe pain
- pelvic infection
- heavy bleeding
- perforation of the uterus
- blood clots
Reports of Serious Complications from IUD Removal Are Increasing
Media reports are starting to capture the full extent of this product defect. One investigation chronicled the full extent of the problem. The media outlet interviewed one woman who thought that Paragard was a low-maintenance birth control device.
However, when she went to remove the device, there was a piece still inside her. The missing piece showed up on an x-ray, and she needed surgery to remove it.
Paragard removal can cause women to become infertile. Their uterus and reproductive system may be permanently damaged, and they may lose their fertility.
Thousands of Reports of Removal Problems in the FDA Database
The FDA maintains a database of adverse event reports. This same media report detailed above found over 3,000 reports of device breakage as of early 2021.
Almost two-thirds of these reports were classified as serious problems. 102 of these women suffered life-threatening side effects and required hospitalization. There have been 15 deaths associated with Paragard side effects.
The FDA Will Not Act to Protect Women
Despite the mounting reports of danger and a slew of lawsuits from women who experienced intense pain and require surgical removal of pieces of plastic, the FDA refuses to act to pull Paragard from the market, even though the manufacturer is making claims about the effectiveness of its intrauterine device without warning of dangers.
This means that women are on their own in making healthcare decisions about their own IUD and whether to even get one in the first place.
One would expect that the FDA order this product removed given the escalating reports of side effects, but that does not appear to be happening in the future.
What to Do if You Are In Pain After Your Paragard Removal
If you have had your Paragard device removed and are experiencing pain in the days afterward, you should call your doctor to make an appointment. The medical professional could run tests to see if there are pieces of plastic from your IUD device lodged in your uterus.
Your doctor will help determine your course of treatment to remove the plastic from your body. Nonetheless, before you even opt for an IUD device such as Paragard for preventing pregnancy, you should get professional medical advice to consider your birth control options.
Contact a Paragard IUD Removal Attorney
For more information about your legal options if you have been injured when your Paragard IUD was removed, contact the attorneys at Rosenfeld Injury Lawyers.
We can help you file a lawsuit against Cooper Cos, the manufacturer of this device, under the theory that the product that they sold you was defective.