TRUMBULL, Conn.--(BUSINESS WIRE)--CooperSurgical, a global leader in women’s healthcare, today announced the launch of a new inserter designed for single-hand placement of Paragard®, which was recently approved by the U.S. Food and Drug Administration (FDA). The new single-hand inserter simplifies the placement process for healthcare providers, making Paragard an even more accessible contraceptive choice for both providers and patients. Paragard, the #1 prescribed copper intrauterine device (IUD), is a tried and true, non-hormonal contraceptive option with more than 30 years of clinical use.
“Paragard has been a reliable contraceptive choice for patients for over three decades due to its continuous 10-year efficacy, immediate reversibility, and hormone-free composition,” said Dr. Lee P. Shulman, board-certified obstetrician-gynecologist and 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 is immediately reversible and offers over 99% efficacy for up to 10 years1 providing women with reliable, long-term contraception. A Paragard market survey found that 91% of users ages 25-50 were satisfied with Paragard overall after at least one year.*3 The newly approved inserter, with its built-in loading tip and single-hand functionality, simplifies the placement procedure without compromising the reliability of Paragard itself.
“We are constantly striving to meet the evolving needs of healthcare providers, and the patients they serve,” said Holly Sheffield, President of CooperSurgical. “With nearly 8 million women choosing Paragard, the new inserter simplifies the placement process and marks a significant milestone for the product. It reaffirms our mission to deliver innovative and safe solutions that positively impact the lives of patients and providers everywhere.”
Paragard with the new single-hand inserter is now commercially available. For more information on Paragard, please visit Paragard.com.
* Based on an April 2023 Paragard User Survey Report, a web-based survey of women aged 18-50 (n=1004), data for age 25-50 (n=904) who currently use Paragard birth control and have for at least 1 year.
About Paragard
Paragard is a hormone-free IUD that prevents pregnancy for up to 10 years using copper.
Important Safety Information
- Don’t use Paragard if you are or may be pregnant, have fibroids, a pelvic infection including pelvic inflammatory disease (PID), get infections easily, certain cancers, unexplained bleeding, Wilson’s disease, or a copper allergy. IUDs, including Paragard, have been associated with an increased risk of PID.
- Pregnancy with Paragard is rare but can be life threatening and cause infertility or loss of pregnancy.
- Paragard may attach to or go through the uterus and cause other problems.
- Tell your healthcare provider (HCP) if you develop severe pain or fever shortly after placement, miss a period, have abdominal pain, or if Paragard comes out. If it comes out, use backup birth control.
- Tell your HCP you have Paragard before having an MRI or a medical procedure using heat therapy.
- At first, periods may become heavier and longer with spotting in between.
- Additional common side effects include anemia, pain during sex, backache, and vaginal discharge.
- Paragard does not protect against HIV or STDs.
Only you and your HCP can decide if Paragard is right for you. Available by prescription only.
You are encouraged to report negative side effects of prescription drugs to the FDA at www.fda.gov/medwatch or call 1-800-FDA-1088.
Click here for the Full Prescribing Information for Paragard.
About CooperSurgical
CooperSurgical is a leading fertility and women's healthcare company dedicated to putting time on the side of women, babies, and families at the healthcare moments that matter most in life. CooperSurgical is at the forefront of delivering innovative assisted reproductive technology (ART) and genomic solutions that enhance the work of ART professionals to the benefit of families. We currently offer over 600 clinically relevant medical devices to women's healthcare providers, including testing and treatment options.
CooperSurgical is a wholly-owned subsidiary of CooperCompanies (Nasdaq: COO). CooperSurgical, headquartered in Trumbull, CT, produces and markets a wide array of products and services for use by women's health care clinicians. More information can be found at www.coopersurgical.com.
About CooperCompanies
CooperCompanies (Nasdaq: COO) is a leading global medical device company focused on improving lives one person at a time. The Company operates through two business units, CooperVision and CooperSurgical. CooperVision is a trusted leader in the contact lens industry, improving the vision of millions of people every day. CooperSurgical is a leading fertility and women’s health company dedicated to assisting women, babies and families at the healthcare moments that matter most. Headquartered in San Ramon, CA, CooperCompanies (“Cooper”) has a workforce of more than 15,000 with products sold in over 130 countries. For more information, please visit www.coopercos.com.
Forward-Looking Statements
This press release contains "forward-looking statements" as defined by the Private Securities Litigation Reform Act of 1995 including, among others, statements regarding a product launch and features and technologies that may impact demand for new products. Forward-looking statements necessarily depend on assumptions, data or methods that may be incorrect or imprecise and are subject to risks and uncertainties. Among the factors that could cause actual results and future actions to differ materially from those described in forward-looking statements are risks relating to challenges inherent in developing, manufacturing, launching, marketing, and selling new products; risks relating to research and development, regulatory requirements, clinical studies, sales, marketing, and distribution plans and capabilities; potential product performance and quality issues; intellectual property risks; competition; and other factors described in CooperCompanies’ Securities and Exchange Commission filings, including the “Business”, “Risk Factors” and "Management's Discussion and Analysis of Financial Condition and Results of Operations" sections in Cooper’s Annual Report on Form 10-K for the fiscal year ended October 31, 2023, as such Risk Factors may be updated in annual and quarterly filings. CooperCompanies cautions investors that forward-looking statements reflect the company’s analysis only on their stated date. CooperCompanies disclaims any intent to update them except as required by law.
References
- Paragard® Package Insert, Trumbull, CT: CooperSurgical, Inc. 2024.
- Trussell J. Contraceptive failure in the United States. Contraception. 2011;83:397-404.
- Data on File.
Paragard® is a registered trademark of CooperSurgical, Inc.
© 2024 CooperSurgical, Inc. C-US-PAR-000669 July 2024
