FDA highlights significant risks related to Essure birth control

The Food and Drug Administration added serious risks, patient information and physician information to the agency’s website related to Essure permanent birth control: 

From the FDA site: 

Essure is a permanent birth control method for women (female sterilization). Implantation of the Essure System does not require a surgical incision. In the procedure, a health care provider inserts flexible coils through the vagina and cervix and into the fallopian tubes – the tubes that carry the eggs from the ovaries to the uterus. Over a period of about three months, tissue forms around the inserts. The build-up of tissue creates a barrier that keeps sperm from reaching the eggs, thus preventing conception. Essure is considered a permanent form of birth control and therefore is not intended to be removed.

Over the past several years, the FDA has been examining the growing number of reports of harm with Essure. The adverse events reported associated with the use of the Essure System include persistent pain, perforation of the uterus and/or fallopian tubes, intra-abdominal or pelvic device migration, abnormal or irregular bleeding, and allergy or hypersensitivity reactions. Some women have had surgical procedures to remove the device. In addition, Essure System failure, and, in some cases, incomplete patient follow-up have resulted in unintended pregnancies.

The FDA convened a meeting of the Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee on September 24, 2015, to hear expert scientific and clinical opinions as well as patients’ experiences regarding the benefits and risks of the Essure System. In addition, a public docket soliciting comments on the device remained open from July 22, 2015 until October 24, 2015. FDA received more than 2,800 comments in this docket and is reviewing each comment and the views and perspectives expressed.

The panel meeting and docket provide valuable information to inform the FDA’s decision-making processes, including the Agency’s consideration of potential risk mitigation strategies. This information is under careful review in FDA. We expect to complete our review and communicate publically about our next steps at the end of February 2016.

 http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/EssurePermanentBirthControl/default.htm

Petitioning The FDA For A Black Box Warning On Opioids and Benzos

Rhode Island health officials are calling on the Food and Drug Administration to warn consumers about the danger of combining prescription painkillers with anti-anxiety medications. That combination has fueled a rising number of accidental drug overdose deaths.
Read more here: http://ripr.org/post/petitioning-fda-black-box-warning-opioids-and-benzos

Lucy's Weight Loss System recalls dietary supplements

Lucy's Weight Loss System of Arlington, Texas, is recalling all lots of Pink Bikini and Shorts on the Beach Capsules in all colors, 30 count (750MG per capsule)

The products are tainted with Sibutramine, Phenolphthalein, and/or Diclofenac, active ingredients not declared on the label.

Sibutramine, an appetite suppressant, was withdrawn from the U.S. market in October 2010. Phenophthalein is not currently approved for marketing in the U.S. because of concerns of carcinogenicity. Use of Diclofenac in patients already taking NSAIDS, with allergies, with underlying illnesses or with recent cardiac bypass surgery, could lead to gastrointestinal disturbances, fatal heart attack or stroke.

https://cdanews.com/2016/01/lucys-weight-loss-system-recalls-pink-bikini-and-shorts-on-the-beach-diet-pills/

Isolux (Naples, FL) Gets a Warning Letter over its A/C Powered Illuminators

From the FDA Letter:

During an inspection of your establishment located in Naples, FLon November 4, 2015 through November 6, 2015, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures A/C Powered Illuminators. Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), [21 U.S.C. § 321(h)], these products are devices because they are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or are intended to affect the structure or function of the body.

 

This inspection revealed that these devices are adulterated within the meaning of section 501(h) of the Act, [21 U.S.C. § 351(h)], in that the methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation are not in conformity with the Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) regulation found at Title 21, Code of Federal Regulations (CFR), Part 820. 

 

These violations include, but are not limited to, the following:

 

1.      Failure to adequately establish procedures for corrective and preventive actions (CAPA) as required by 21 CFR 820.100(a). Specifically, your firm conducted CAPA activities related to spot uniformity and homogeneity of your fiber optic cable illumination and misalignment of your Isovu Headlight Camera System in March 2011. The records for these CAPAs did not include documentation related to your investigation into underlying causes and verification or validation of the corrective action. 

 

This is a continued observation from previous inspections of your firm in January 2010 and August 2005.

 

2.      Failure to adequately establish procedures to ensure that all purchased or otherwise received product and services conform to specified requirements as required by 21 CFR 820.50. Specifically, Section 4.2 of your Quality System Regulation Manual (QSRM) outlines your purchasing controls. Your firm did not implement these procedures to adequately qualify the new supplier of your fiber optic cables in 2011.  

 

This is a continued observation from previous inspections of your firm in January 2010 and August 2005.

 

3.      Failure to adequately establish procedures for acceptance of incoming product, as required by 21 CFR 820.80(b). Specifically, your firm relies on your suppliers’ Certificates of Analysis and a UL certification for incoming products. These activities do not ensure that these incoming products meet your product specifications.

 

4.      Failure to establish and maintain procedures for design change, as required by 21 CFR 820.30(i). Specifically, Section 2 of your QSRM outlines your firm’s procedures for design change. These procedures do not include requirements for the identification, documentation, validation or verification, and approval of design changes prior to implementation.

 

5.      Failure to establish and maintain a design history file (DHF) for each type of device, as required by 21 CFR 820.30(j). Specifically, your firm has not established a DHF for your 1180 XSB Xenon Light Source devices to demonstrate that the design was developed in accordance with an approved design plan. Additionally, a review of your DHF did not include documented evidence that the design was approved for transfer into production.

 

We acknowledge receipt of your response on December 1, 2015 concerning our investigator’s observations noted on the Form FDA 483 (FDA 483), Inspectional Observations, issued to your firm on November 6, 2015. Your response did not provide adequate supporting evidence that the referenced corrections and planned courses of action have been implemented. 

 

Your firm should take prompt action to correct the violations addressed in this letter.  Failure to promptly correct these violations may result in regulatory action being initiated by the FDA without further notice.  These actions include, but are not limited to, seizure, injunction, and civil money penalties.  Also, federal agencies may be advised of the issuance of Warning Letters about devices so that they may take this information into account when considering the award of contracts. Additionally, premarket approval applications for Class III devices to which the Quality System regulation violations are reasonably related will not be approved until the violations have been corrected.  Requests for Certificates to Foreign Governments will not be granted until the violations related to the subject devices have been corrected.

http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm482382.htm

FDA Recalls Skinny Latina Million Dollar Marinade Over Undeclared Ingredient

New of a recent recall of Skinny Latina Million Dollar Marinade bottles from stores for containing undeclared soy. People who are allergic to soy should not consume the product.

The product is available in clear 12-ounce glass bottles with a label on the back stating when it is best consumed. All bottles with the label, “Best By 12-15-15” or earlier, are being recalled. The bottles did not include the corrected labels stating that these contain soy.

The recall was triggered by the discovery of soy in its gluten-free teriyaki sauce ingredient, without the packaging indicating its presence. It is important to note that Skinny Latina Foods Inc. voluntarily recalled the distributed products immediately after, the same press release states.

http://www.latinpost.com/articles/109995/20160120/fda-recalls-skinny-latina-million-dollar-marinade-over-undeclared-ingredient.htm