# Novel Biofilm Paradigm Explaining Clinical Implant-Associated Illness.

> **NIH NIH R21** · INDIANA UNIVERSITY INDIANAPOLIS · 2022 · $231,040

## Abstract

PROJECT SUMMARY
This is a proposal from an investigator to address the mechanistic underpinnings of host-biofilm interaction in
the context of surgical implant-associated complications. It is estimated 10 million women worldwide, including
3 million Americans have breast implants. Over 7 million Americans are living with hip/knee implants. Nearly
300,000 women annually have breast implant surgery in the United States, for reasons including post-
mastectomy breast reconstruction (breast cancer and prophylactic mastectomy), revision of prior augmentation/
reconstruction, cosmetic augmentation, and gender affirmation. Over 1 million total hip and total knee
replacement surgeries are performed each year in the US. With an aging population, there is a demand for
improved mobility and quality of life. The number of joint replacement surgeries are projected to increase
considerably in the future. Total joint replacement surgery is expected to continue to be one of the most common
elective surgical procedures in the coming decades.
There has been increased identification of patients experiencing a constellation of symptoms related to their
implants. The symptoms described include myalgias, chronic fatigue, connective-tissue disorders, and a host of
other manifestations often associated with autoimmune illnesses. Metal/plastic implants for arthroplasty and
silicone implants for breasts are made of different materials. Thus, the underlying cause of these conditions may
be associated with factors other than the implant material. Bacterial biofilms are one of the leading causes of
surgical implant failures, infection and revision surgeries. Despite efforts to maintain sterility during surgery,
implantable medical devices can become contaminated with the opportunistic bacteria from the host microflora
many of which can form biofilm.
This proposal aims to investigate the role of bacterial biofilms in the implant-associated illness. Host-biofilm
interactions are guided by the local micro-environmental niche of host in which the biofilm reside. Breast and hip
joint replacements have a host-microenvironment rich in adipose tissue comprising lipids. The proposal aims to
study lipid metabolites (oxylipins) formed during biofilm-host interaction. Oxylipins are oxidized lipids formed from
fatty acids by reactions involving dioxygen-dependent oxidation. Oxylipins have been reported to contribute to
inflammatory response. We hypothesize that oxylipins formed due to biofilm can stimulate CD4+ T cell leading
to autoimmune-like syndromes.

## Key facts

- **NIH application ID:** 10515767
- **Project number:** 1R21AI171932-01
- **Recipient organization:** INDIANA UNIVERSITY INDIANAPOLIS
- **Principal Investigator:** Mithun Sinha
- **Activity code:** R21 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $231,040
- **Award type:** 1
- **Project period:** 2022-05-26 → 2024-04-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10515767

## Citation

> US National Institutes of Health, RePORTER application 10515767, Novel Biofilm Paradigm Explaining Clinical Implant-Associated Illness. (1R21AI171932-01). Retrieved via AI Analytics 2026-05-27 from https://api.ai-analytics.org/grant/nih/10515767. Licensed CC0.

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