CooperSurgical unveils new inserter for simplified Paragard IUD placement
The new single-handed inserter by CooperSurgical streamlines the placement of Paragard, a hormone-free IUD with over 30 years of proven efficacy, enhancing accessibility for both health care providers and patients.
CooperSurgical unveils new inserter for simplified Paragard IUD placement | Image Credit: © Mariakray - © Mariakray - stock.adobe.com.
CooperSurgical has announced the launch of a newly FDA-approved inserter designed for single-handed placement of Paragard, a hormone-free copper intrauterine device (IUD).1
With over 30 years of clinical use, Paragard is the most common prescribed copper IUD in the United States. By simplifying the placement process for health care providers, the new inserter increases the accessibility of this contraceptive method.
Data has indicated over 99% efficacy for Paragard for up to 10 years, making it a reliable, long-term contraceptive method. Among Paragard users aged 25 to 50 years, 91% reported satisfaction after at least 1 year of use in a market survey. The new inserter makes the placement process simpler without impacting efficacy.
“Paragard has been a reliable contraceptive choice for patients for over 3 decades due to its continuous 10-year efficacy, immediate reversibility, and hormone-free composition,” said Lee P. Shulman, MD, professor at Northwestern University’s Feinberg School of Medicine. “The new single-hand inserter is intuitive for providers. It simplifies the insertion process, making it convenient for healthcare providers and their patients.”
Paragard should not be used in individuals who are pregnant, have fibroids or a pelvic infection, get infections easy, or experiences certain cancers or unexpected bleeding. Patients should tell their health care provider if they develop severe pain or fever shortly after placement, miss a period, or have abdominal pain.
Periods may be heavier and longer in the immediate aftermath of Paragard insertion. Other side effects include backache, pain during sex, anemia, and vaginal discharge. While pregnancy is rare after insertion, it can be life-threatening and lead to infertility or pregnancy loss. Other problems may occur if Paragard attaches or goes through the uterus.
Paragard is inserted at the fundus of the uterine cavity, and removal should occur no later than 10 years after the insertion date.2 However, if the patient desires continued Paragard use, it may be replaced at the time of removal.
Patients not currently using contraception may begin Paragard use at any time. Similarly, those switching to Paragard from an oral, transdermal, or vaginal contraceptive may begin Paragard immediately after discontinuation of the previous method.
When switching from another intrauterine system (IUS), Paragard may be inserted on the same day the IUS is removed. Paragard may also be inserted immediately after abortion or postpartum, as it is safe to breastfeed when using Paragard. Strict aseptic techniques should be utilized during the insertion procedure.
The efficacy of Paragard was proven in 2 clinical studies, the first of which was conducted by the World Health Organization. This was a randomized, multicenter, multinational study including 1396 parous women aged a mean 29 years.
The second study of Paragard was a meta-analysis of randomized, double-blind, comparative studies of copper T IUSs. Paragard was evaluated in 3536 US women, 64% of whom were nulliparous and 49% were nulligravida. Participants were aged a mean 23 years. Across both studies, a pregnancy rate of less than 1 in 100 was reported.
Patients should contact their health care provider if pelvic pain or pain during sex occurs. Additional adverse events that should lead to discussions with a health care provider include unusual vaginal discharge, possible exposure to sexually transmitted infections, severe or prolonged vaginal bleeding, and missed period.
References
- CooperSurgical launches Paragard intrauterine copper contraceptive with new single-hand inserter. Business Wire. September 3, 2024. Accessed September 4, 2024. https://www.businesswire.com/news/home/20240903577341/en/CooperSurgical-Launches-Paragard%C2%AE-Intrauterine-Copper-Contraceptive-with-New-Single-Hand-Inserter
- Paragard intrauterine copper contraceptive. CooperSurgical. Accessed September 4, 2024. https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.paragard.com%2Fwp-content%2Fuploads%2F2018%2F10%2FPARAGARD-PI.pdf&esheet=54114781&newsitemid=20240903577341&lan=en-US&anchor=Full+Prescribing+Information&index=4&md5=0f219f0697356858b82f0f72e3d738e9&_gl=1*1u9hmr1*_gcl_au*NTc4MTE3OTE1LjE3MjU0NTQ4MTQ.*_ga*MTA0NTgxNjIyOS4xNzI1NDU0ODE0*_ga_ZQWF70T3FK*MTcyNTQ1NDgxNC4xLjEuMTcyNTQ1NjEzNy42MC4wLjA.
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