Tampon Safety: Biocompatibility and Toxicology Program: Research on Medical Devices, Biocompatibility, and Toxicology

[Mary Wilson]

September 10, 2024

The FDA is aware of concerns about tampon safety after a 2024 study found metals in tampons during laboratory testing. We want the public to know that before tampons can be legally sold in the U.S., they must meet FDA requirements for safety and effectiveness. Manufacturers must test the product and its component materials before, during, and after manufacturing. Before a product is allowed onto the market, biocompatibility testing is undertaken by the manufacturing company, which is part of safety testing, and is reviewed by the FDA prior to market authorization.

While the study found metals in some tampons, the study did not test whether metals are released from tampons when used. It also did not test for metals being released, absorbed into the vaginal lining, and getting into the bloodstream during tampon use.

The FDA has therefore commissioned an independent literature review and initiated an internal bench laboratory study to evaluate metals in tampons. The comprehensive review of the published literature will provide a better understanding of the data currently available regarding the presence of chemicals in tampons and, importantly, any associated health effects of those chemicals. The FDA’s laboratory study will measure the amount of metals that come out of tampons under conditions that more closely mimic normal use. These initiatives will enable the FDA to complete a risk assessment of metals contained in tampons, based on a worst-case scenario of metal exposure. The FDA will communicate our findings from the literature review and lab testing publicly when they are available and have been peer reviewed. The FDA will also continue monitoring these devices as part of its total product lifecycle approach to medical devices.

Any tampon currently cleared by the FDA has been evaluated as described in the guidance document Menstrual Tampons and Pads: Information for Premarket Notification Submissions (510(k)s) and was determined to meet FDA premarket requirements.

The Biocompatibility and Toxicology Program in the FDA’s Center for Devices and Radiological Health (CDRH) conducts regulatory science research on the interactions between medical devices and the human body to help ensure patient access to innovative devices that are safe and effective. This is one of 20 research programs in CDRH’s Office of Science and Engineering Laboratories (OSEL).

Biocompatibility, Toxicology, and Medical Devices

All medical devices that contact the human body undergo biocompatibility safety assessments prior to market release. Pre-clinical research undertaken to address pre-market questions raised about the biocompatibility of medical devices is multidisciplinary and encompasses the use of biological evaluation and toxicological risk assessment technologies including novel in vitro, ex vivo/in vivo testing, and computational/in silico methodologies.

The Biocompatibility and Toxicology Program (BTP) addresses the biological and toxicological safety of the broad spectrum of medical devices currently on the market and emergent technologies (such as novel materials). The regulatory science efforts of the BTP are cross-cutting and span multiple medical device product lines to support the regulatory activities across all OPEQ offices. Specifically, the scope of this program is focused on promoting the acceptance/qualification of methods/tools (such as New Approach Methodologies [NAMs]*) or development of international standards or guidance for:

• evaluating biocompatibility (i.e., biological) endpoints and
• evaluating/estimating toxicological risk.

* Note: NAMs include a broad range of "alternative methods" such as in vitro, in chemico, in silico (such as, computational, bioinformatics), and systems biology approaches. In vivo methods can also be considered NAMs when they improve predictivity, shift studies to phylogenetically lower animals, or help replace, reduce, and refine animal use (that is, the 3Rs).

Regulatory Science Gaps and Challenges

The major regulatory science gaps and challenges that drive the Biocompatibility and Toxicology Program are:

• Insufficient New Alternative Methodologies (NAMs) validated/qualified for biocompatibility assessment of medical devices.
• A need for tools/methods (such as web-based/computational, guide) that facilitate and improve consistency of toxicological risk assessments for medical devices.
• Inadequate guidelines for evaluating biocompatibility of medical devices throughout their device lifetime.

Through regulatory science research, the Biocompatibility and Toxicology Program seeks to fill these knowledge gaps in order to improve and advance safety assessment approaches that are least burdensome to the medical device industry without compromising patient safety. To achieve this goal, the Biocompatibility and Toxicology Program evaluates new, as well as refines current, testing approaches to help harmonize methods for biocompatibility evaluation of medical devices and promote further consistency in the regulatory review of pre-market submissions.

Biocompatibility and Toxicology Program Activities

Currently, the Biocompatibility and Toxicology Program focuses on regulatory science research in the following areas:

• Evaluating the performance of in vitro test methods (such as reconstructed human epidermis [RhE] irritation test) with the objective to support their regulatory acceptance for assessing the biological risk(s) of medical devices.
• Establishing toxicological risk assessment tools (such as based on ISO 10993-17) to standardize calculations and promote uniformity in the toxicological risk assessment of medical devices.

For more information, email OSEL_biocomptox@fda.hhs.gov

https://www.fda.gov/medical-devices/medical-device-regulatory-science-research-programs-conducted-osel/biocompatibility-and-toxicology-program-research-medical-devices-biocompatibility-and-toxicology

[Mary Wilson]

Tampons as a source of exposure to metal(loid)s - Science Direct

August 2024, 108849

https://doi.org/10.1016/j.envint.2024.10884

Jenni A. Shearston ^{a b}, Kristen Upson ^c, Milo Gordon ^a, Vivian Do ^a, Olgica Balac ^a, Khue Nguyen ^d, Beizhan Yan ^d, Marianthi-Anna Kioumourtzoglou ^a, Kathrin Schilling ^a

Highlights

• •
  
  16 metal(loid)s were evaluated in different kinds of tampons.
• •
  
  Several toxic metals, including lead, were detected.
• •
  
  Tampon use is a potential source of exposure to metals in menstruating people.
• •
  
  The highest concentration was found for zinc (geometric mean = 52,000 ng/g)
• •
  
  A geometric mean lead concentration of 120 ng/g was found in our samples.

Abstract

Background
Between 52–86% of people who menstruate in the United States use tampons—cotton and/or rayon/viscose ‘plugs’—to absorb menstrual blood in the vagina. Tampons may contain metals from agricultural or manufacturing processes, which could be absorbed by the vagina’s highly absorptive tissue, resulting in systemic exposure. To our knowledge, no previous studies have measured metals in tampons.

Objectives
We evaluated the concentrations of 16 metal(loid)s in 30 tampons from 14 tampon brands and 18 product lines and compared the concentrations by tampon characteristics.

Methods
About 0.2 – 0.3 g from each tampon (n = 60 samples) were microwave-acid digested and analyzed by inductively coupled plasma mass spectrometry (ICP-MS) to determine concentrations of arsenic, barium, calcium, cadmium, cobalt, chromium, copper, iron, manganese, mercury, nickel, lead, selenium, strontium, vanadium, and zinc. We compared concentrations by several tampon characteristics (region of purchase, organic material, brand type) using median quantile mixed models.

Results
We found measurable concentrations of all 16 metals assessed. We detected concentrations of several toxic metals, including elevated mean concentrations of lead (geometric mean [GM] = 120 ng/g), cadmium (GM = 6.74 ng/g), and arsenic (GM = 2.56 ng/g). Metal concentrations differed by region of tampon purchase (US versus European Union/United Kingdom), by organic versus non-organic material, and for store- versus name-brand tampons. Most metals differed by organic status; lead concentrations were higher in non-organic tampons while arsenic was higher in organic tampons. No categoriy had consistently lower concentrations of all or most metals.

Discussion
Tampon use is a potential source of metal exposure. We detected all 16 metals in at least one sampled tampon, including some toxic metals like lead that has no “safe” exposure level. Future research is needed to replicate our findings and determine whether metals can leach out of tampons and cross the vaginal epithelium into systemic circulation.

https://www.sciencedirect.com/science/article/pii/S0160412024004355