Summary Safety Review - U by Kotex Sleek and U by Kotex Click Tampons - Assessing the risk of tampons coming apart during removal and potential adverse reactions (side effects)

Review decision

A Summary Safety Review complements other safety related information to help Canadians make informed decisions about their use of health products. Each summary outlines what was assessed in Health Canada’s review, what was found and what action was taken by Health Canada, if any.

Product

U by Kotex Sleek and U by Kotex Click Menstrual Tampons

Potential Safety Issue

Tampons coming apart during removal and potential adverse reactions (side effects) if pieces are not all removed from the body

Key Messages

U by Kotex Sleek and U by Kotex Click are menstrual tampons.
Health Canada's safety review was triggered by an increase in the number of complaints/incidents reported in Canada related to U by Kotex Sleek and U by Kotex Click tampons, with the majority of reports describing tampons coming apart during removal.
Health Canada requested more information from the manufacturer after a small number of reports described symptoms that could have been related to toxic shock syndrome (TSS). TSS is a condition resulting from bacteria getting into the body and releasing toxins.
In response to reports of U by Kotex Sleek tampons coming apart and of adverse reactions, the manufacturer initiated a voluntary recall (product removal) of certain batches (lots) in December 2018.
A recall of the U by Kotex Click tampons was not necessary given the lower rate of tampons coming apart and the use of different manufacturing equipment.
Based on a review of all available information, Health Canada concluded that the voluntary recall done by the manufacturer was satisfactory.
Health Canada will work with the manufacturer to monitor the effectiveness of the corrective measures taken to address the risk of tampons coming apart during use, and will continue to actively monitor the safety of these medical devices.

Overview

As part of its post-market surveillance, Health Canada observed an increase in the number of incidents reported since 2017 related to U by Kotex Sleek and U by Kotex Click tampons coming apart during removal. Some users needed medical attention to remove tampon pieces left in the body, or had adverse reactions such as infections, vaginal irritation, abdominal pain, fever, nausea or headaches.

A menstrual tampon is a soft material product that is inserted into the vagina to absorb blood during a woman's menstrual period. It may or may not come with an applicator to help insertion. A tampon may have an attached string to help remove it. Using tampons may present certain health risks, including toxic shock syndrome (TSS), a condition resulting from bacteria getting into the body (bloodstream) and releasing toxins. It is a rare but serious infection that has initial symptoms similar to the flu. These risks are increased if tampons are left in too long.

More information on menstrual tampons, including information to help users minimize the potential health risks of tampon use, can be found here.

Use in Canada

U by Kotex Sleek and U by Kotex Click are menstrual tampons.
These tampons are widely available in Canada and are manufactured by Kimberly-Clark.

Safety Review Findings

Health Canada observed an increase in the number of reports related to U by Kotex Sleek and U by Kotex Click tampons coming apart during removal. In the majority of reports, there was no reported injury to the user, but some needed medical attention to remove tampon pieces left in the body. A small number of reports described symptoms that could have been related to toxic shock syndrome (TSS), such as abdominal pain, fever, headache, infection, nausea, vaginal irritation, and vomiting.
On December 11, 2018, the manufacturer announced a recall to withdraw certain batches of U by Kotex Sleek tampons from the Canadian market due to a manufacturing issue that made them more likely to come apart during removal.
As part of this safety review, Health Canada requested more information from the manufacturer. This information clarified that:
- Corrective actions were taken by the manufacturer to address the increase in reports of U by Kotex Sleek and U by Kotex Click tampons coming apart during removal.
- The rate of tampons coming apart was several times lower for U by Kotex Click tampons compared to that for U by Kotex Sleek tampons.
- U by Kotex Click tampons were not manufactured on the same equipment that produced the recalled batches of defective U by Kotex Sleek tampons.
At the time of the safety review, one case of toxic shock syndrome (TSS) had been reported to Health Canada that was related to U by Kotex Click tampons in 2013. One case has been reported that was related to U by Kotex Sleek tampons in 2014.
Health Canada found the corrective actions taken by the manufacturer to be satisfactory. A recall of the U by Kotex Click tampons was not necessary given the lower rate of tampons coming apart and the use of different manufacturing equipment.

Conclusions and actions

This safety review concluded that the recall initiated by the manufacturer on December 11, 2018, for specific batches of U by Kotex Sleek tampons addressed the observed increased reporting of tampons coming apart for this product. A recall of U by Kotex Click tampons is not necessary at this time.
Health Canada will work with the manufacturer to ensure that the actions taken to correct the issue of tampons coming apart during removal have been effective.
Health Canada will continue to monitor safety information involving all menstrual tampons, as it does for all medical devices on the Canadian market, to identify and assess potential harms. Health Canada will take appropriate and timely action if and when any new health risks are identified.

Additional information

The analysis that contributed to this safety review included scientific and medical literature, Canadian and international adverse reaction reports and what is known about the use of these medical devices both in Canada and internationally.

For additional information, contact the Marketed Health Products Directorate.

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Summary Safety Review - U by Kotex Sleek and U by Kotex Click Tampons - Assessing the risk of tampons coming apart during removal and potential adverse reactions (side effects)

Review decision