ParaGard Recall: Copper IUD Recall Update

Fact-Checked by: Our Staff

Despite a rising number of lawsuits and reports of serious injuries in women, ParaGard remains on the market today. The intrauterine device (IUD) is just the latest in a long line of birth control implants that have had disastrous impacts on the women that it was supposed to help

However, the manufacturer of the product makes too much money on the product to voluntarily recall it, and the FDA has not acted to protect consumers who run the risk of being injured.

There are two different kinds of IUDs on the market. There are devices that release a small amount of hormones into the body. Then, there are non-hormonal IUDs. ParaGard falls into the latter category.

ParaGard Is Another in a Long Line of IUD Failures

IUDs have had a tortured history in the United States. One of the original products in this line, the Dalkon Shield, was the subject of one of the largest mass torts in American history. Over 200,000 women filed lawsuits against the manufacturer of the product for serious complications that included infections, infertility, and pelvic inflammatory disease. A.H. Robins, the maker of the Dalkon Shield, was forced into bankruptcy by the lawsuits. Another IUD, Mirena, has led to lawsuits because the IUD became lodged and perforated in the uterus. These have given IUDs, in general, a bad name, yet companies still sell the products.

Currently, Cooper Companies is the maker of ParaGard. Sensing profit potential, it paid $1.1 billion for the brand to buy it from Teva Pharmaceutical. At the time of the sale, financial disclosures showed that ParaGard did $168 million in annual sales. Obviously, Cooper Companies intends to keep selling the product in spite of the reports of harm.

ParaGard is a t-shaped plastic device that measures just under an inch and a half. It has strings attached to make for supposedly easy removal. It is inserted into the uterus through the cervical canal. The doctor puts the Paragard into an applicator tube to get it into place.

The plastic is wrapped with a copper coil, which is how ParaGard prevents pregnancy. Instead of the devices using hormones to interfere with the body’s processes, it is the copper that accomplishes this. The copper stops the egg and the sperm from meeting as it acts as a spermicide. It also changes the lining of the uterus to prevent pregnancy. With the womb altered, even a fertilized egg would not be able to stick to the uterine walls.

ParaGard Could Degrade as it Remains in the Body

ParaGard is designed to stay in the body between 5-10 years. Women are supposed to carry on as normal as the device works. The legal issue is not with the effectiveness of the device. Most women do not even report side effects when Paragard is in their bodies.

The serious problem for women that is the subject of these lawsuits is taking the ParaGard out of the body. After ten years at the latest, the device needs to be removed because it loses effectiveness. The makers of the product have touted how easy it is to remove ParaGard. According to them, doctors simply need to pull on the attached strings, and the device will simply come out of the body. The claim that the procedure can be done in a doctor’s office and takes minutes. Many women wish it was that simple. Instead, they are suffering side effects that have dramatically impacted their lives

The problem is that the device can degrade after being inside the body for so many years. In particular, the plastic can get worn down and degrade. When the doctors pull on the strings to remove them from the body, the plastic can break apart, sometimes into small pieces. This could send tiny pieces of plastic scattering throughout a woman’s uterus. These can poke and damage the uterus and tissue in the body.

Device Breakage Could Require Serious Surgery

The difficulty is that the very small scattered pieces of plastic are very difficult to remove. In the worst-case scenario, women would need a hysterectomy to fully remove the tiny plastic pieces. Otherwise, they would continue to suffer intense pain and ongoing damage to their uterus.

There have been over 1,600 reports made to the FDA of device breakage. However, a ParaGard recall does not seem to be in the cards. The company still claims that their products work, and they will continue to sell them. Therefore, Cooper will not voluntarily issue a ParaGard IUD recall. Cooper simply paid too much money too recently for ParaGard to admit that they bought a dangerous product, and they do not want to open themselves up to legal liability that would follow a recall. This does not completely rule out a future recall of ParaGard, especially as reports of injuries mount.

In the meantime, you can contact a product liability lawyer if you or a loved one has been injured by ParaGard. Injured women have been filing lawsuits against Cooper and Teva for the damages that they have suffered when the plastic broke and scattered pieces into their bodies. 

FAQs

Here are the answers to questions that we are frequently asked about ParaGard lawsuits:

How Much Is My Case Worth?

It depends on how much you have suffered. Normally you would receive economic damages such as lost wages and doctor bills and non-economic damages that would include emotional distress and pain and suffering.

How Long Will My ParaGard Case Take?

Product liability lawsuits can take years to go to trial, but many defendants choose to settle cases early to cut down on their legal risk.

Can I Afford a ParaGard Lawsuit Attorney?

You absolutely can. Attorneys would take your case on a contingency basis, and you pay no money upfront and do not owe anything unless you win your case.

Take The First Step

844-373-7597

We’ll evaluate your case for free, and determine if you are entitled to compensation.