Bayer HealthCare & KARL STORZ Enter Collaboration Agreement to Provide Gynecologists Hysteroscopy Solutions Supporting the Procedure for Essure® Permanent Birth Control

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Bayer HealthCare Pharmaceuticals, Inc.

Nov 03, 2014, 09:37 ET

WHIPPANY, N.J., Nov. 3, 2014 /PRNewswire/ -- Bayer HealthCare Pharmaceuticals, Inc. today announced that it has entered into a collaborative agreement with KARL STORZ Endoscopy-America, Inc. (El Segundo, Ca.), to provide gynecologists with training and streamlined access to equipment used for hysteroscopic procedures including for the placement of Essure® for permanent birth control. In addition, the agreement establishes a comprehensive training platform for OB/GYN residency programs at some of the leading academic centers in the United States to help elevate education among residents on hysteroscopy and proper use of the equipment.

"Our two companies are united in our dedication to advancing minimally invasive surgical techniques among gynecologists," said Jeff Lersch, Vice President, Sales, KARL STORZ. "This agreement is founded upon major strengths of both of our companies, including the expertise KARL STORZ offers in minimally invasive surgery, quality equipment and service and the innovation provided by Bayer with Essure."

For women who have completed their families and desire permanent birth control, Essure may be an option. The Essure procedure can be done in 10 minutes in a doctor's office and there's no down time to recover. Most women go home 45 minutes after the procedure and return to normal activities within a day or two.

KARL STORZ will provide the high-quality equipment and instrumentation for establishing a complete office-based video hysteroscopy program. Hysteroscopic instruments encompass a slender, atraumatic 5 mm hysteroscope and a wide range of 5 Fr. Instruments. The company's office video system includes its TELE PACK X office video system that provides a compact all-in-one solution for visualization of hysteroscopic findings and for recording high-quality video images for documentation.

"This collaboration of two leading healthcare companies offers great potential for enhancing physician support with regard to these procedures," said Paul Bedard, senior vice president and general manager, women's health, Bayer. "Both companies offer exceptional expertise and sense of commitment to serving the needs of customers and patients alike. For gynecologists, this will mean a solid foundation for extending the important services they can offer. And, their patients benefit from having access to an important permanent birth control option."

About Essure®

Indication
Essure® is permanent birth control that works with your body to create a natural barrier against pregnancy.

Important Safety Information
Essure is not right for you if are uncertain about ending fertility, can have only one insert placed, are or have been pregnant within the past 6 weeks, have had your tubes tied, have an active or recent pelvic infection, or have a known allergy to contrast dye.

WARNING: You must continue to use another form of birth control until you have your Essure Confirmation Test (3 months after the procedure) and your doctor tells you that you can rely on Essure for birth control. It can take longer than three months for Essure to be effective. Talk to your doctor about which method of birth control you should use during this period. Women using an intrauterine device need to switch to another method. If you rely on Essure for birth control before receiving confirmation from your doctor, you are at risk of getting pregnant.

WARNING: Be sure you are done having children before you undergo the Essure procedure. Essure is a permanent method of birth control.

During the procedure: In clinical trials some women experienced mild to moderate pain (9.3%). Your doctor may be unable to place one or both Essure® inserts correctly. Although uncommon, part of an Essure insert may break off or puncture the fallopian tube requiring surgery to repair the puncture. Your doctor may recommend a local anesthetic. Ask your doctor about the risks associated with this type of anesthesia.

Immediately following the procedure: In clinical trials some women experienced mild to moderate pain (12.9%) and/or cramping (29.6%), vaginal bleeding (6.8%), and pelvic or back discomfort for a few days. Some women experienced nausea and/or vomiting (10.8%) or fainting. In rare instances, an Essure insert may be expelled from the body.

During the Essure Confirmation Test: You will be exposed to very low levels of radiation, as with most x-rays. In rare instances, women may experience spotting and/or infection.

Long-term Risks: There are rare reports of chronic pelvic pain in women who have had Essure. In rare instances, an Essure insert may migrate through the fallopian tubes and may require surgery No birth control method is 100% effective. Women who have Essure are more likely to have an ectopic pregnancy (pregnancy outside the uterus) if they get pregnant. This can be life-threatening. The Essure insert is made of materials that include a nickel-titanium alloy. Patients who are allergic to nickel may have an allergic reaction to the inserts. Symptoms include rash, itching and hives.

The safety and effectiveness of Essure has not been established in women under 21 or over 45 years old.

Essure does not protect against HIV or other sexually transmitted diseases.

Talk to your doctor about Essure and whether it is right for you.

About KARL STORZ
KARL STORZ Endoscopy-America, Inc. is an affiliate of KARL STORZ GmbH & Co. KG, an international leader for nearly 70 years in reusable endoscope technology, encompassing all endoscopic specialties. Based in Tuttlingen, Germany, KARL STORZ GmbH & Co. KG is a family-owned company that designs, engineers, manufactures, and markets all its products with an emphasis on visionary design, precision craftsmanship and clinical effectiveness. For more information, call (800) 421-0837 or visit the company's Web site at www.karlstorz.com.

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About Bayer HealthCare Pharmaceuticals Inc.
Bayer HealthCare Pharmaceuticals Inc. is the U.S.-based pharmaceuticals business of Bayer HealthCare LLC, a subsidiary of Bayer AG. Bayer HealthCare is one of the world's leading, innovative companies in the healthcare and medical products industry, and combines the activities of the Animal Health, Consumer Care, Medical Care, and Pharmaceuticals divisions. As a specialty pharmaceutical company, Bayer HealthCare Pharmaceuticals Inc. provides products for General Medicine, Hematology, Neurology, Oncology and Women's Healthcare. The company's aim is to discover and manufacture products that will improve human health worldwide by diagnosing, preventing and treating diseases.

Forward-Looking Statement
This news release may contain forward-looking statements based on current assumptions and forecasts made by Bayer Group or subgroup management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer's public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.

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SOURCE Bayer HealthCare Pharmaceuticals, Inc.