Nickel Label
Conceptus Inc., Makers of Essure
331 East Evelyn Avenue
Mountain View, CA 94041, USA
Main 650-962-4000
Fax 650-962-5200
www.conceptus.com
www.essuremd.com
www.essure.com
 
  October  12,  2011

IMPORTANT ESSURE® PERMANENT BIRTH CONTROL SYSTEM LABELING CHANGE
FDA APPROVAL OF THE REMOVAL OF THE NICKEL CONTRAINDICATION FOR ESSURE

 Dear Valued Customer:
 
Conceptus, Inc. would like to inform you of an important update to the instructions for use for the Essure System regarding:
  • The removal of a contraindication for patients with known hypersensitivity to nickel as confirmed by skin test
  • The removal of a warning for patients with a suspected hypersensitivity to nickel to  pursue  a confirmatory skin test
  • The  addition of a warning for patients with suspected hypersensitivity to nickel
Given the clinical relevance of data gathered from the Essure clinical trials and a decade of commercial use, the following label modifications were approved by the US Food and Drug Administration on July 1, 2011.
 
Removed Contraindications statement:
 
“Known hypersensitivity to nickel confirmed by skin test (see Warnings section below for patients with hypersensitivity to nickel.)”
 
Removed Warnings statement:
 
“Patients with suspected hypersensitivity to nickel should undergo a skin test to assess hypersensitivity prior to an Essure placement procedure (see Contraindications section above for patients with known hypersensitivity to nickel).”
 
New Warnings statement:
 
“The Essure micro-insert includes nickel-titanium alloy, which is generally considered safe. However, in vitro testing has demonstrated that nickel is released from this device. Patients who are allergic to nickel may have an allergic reaction to this device, especially those with a history of metal allergies. In addition, some patients may develop an allergy to nickel if this device is implanted. Typical allergy symptoms reported for this device include rash, pruritus, and hives.”
The new labeling was supported by the following information:
  • Nickel sensitivity was not an exclusion criterion in the Essure clinical trials and no short-term adverse events occurred that suggested that the micro-insert was allergenic
  • A review of nine years of commercial experience/adverse events reported did not demonstrate a causal relationship between nickel sensitivity and wearing the Essure micro-insert
  • The number of reported adverse events related to possible allergic reaction to the Essure micro-insert is extremely low; less than 1 in 5,000
Thus, patients with a known hypersensitivity to nickel may now be candidates for the Essure procedure.   However, please be advised that your patients should still be properly counseled about the risks and benefits of the Essure procedure, including the possibility of an allergic reaction to the micro-insert or development of an allergy to nickel.

To obtain a copy of the new Essure IFU, please download it here.

For further information, please contact your Conceptus Sales Representative or call the Physician Consultation line at 877-ESSURE 2 (877-377-8732), prompt 3.

Sincerely,
 
  signature  
  Gary Metz
Director, Clinical and Global Marketing
Conceptus Incorporated
331 East Evelyn Avenue
Mountain View, CA 94041
Phone: 650-962-4000