Civil Liability of Doctors for the Use of Dermal Fillers Without a Marketing Authorization in Medical Aesthetic Services

Citra Cahyarini, Nanik Sutarni, Dwi Imroatus Sholikah, Rivan Picaso

Abstract


The use of dermal fillers in medical aesthetic services is growing rapidly because this procedure is considered to provide fast results, is minimally invasive, and is increasingly popular with the public. Dermal fillers are essentially non-surgical procedures to improve facial contours, reduce wrinkles, or increase soft tissue volume. However, this procedure still carries medical and legal risks and must be performed with safe, legal products that meet the doctor's competence. Legal issues arise when doctors use dermal fillers without a marketing authorization, because this action has the potential to violate medical device safety regulations, cause patient harm, and open up opportunities for civil liability. This study aims to analyze the civil liability of doctors in the use of dermal fillers without a marketing authorization using the Civil Code, consumer protection, and health law approaches. The results of the study indicate that doctors can be held liable based on unlawful acts, breach of contract, and breach of professional obligations and the obligation to ensure the legality of the products used. From a consumer protection perspective, patients are considered consumers of health services who have the right to security, correct information, and compensation for any losses incurred. The use of dermal fillers without a marketing authorization is not only an administrative violation but can also result in serious civil liability for doctors. 


Keywords


Civil Liability; Consumer Protection; Dermal Filler; Doctor; Health Law; Marketing Authorization.

Full Text:

PDF

References


Journals:

Arifin, M., dan D. Rahmawati. “Pengawasan Alat Kesehatan Ilegal dalam Praktik Estetika Medis di Indonesia.” Jurnal Hukum dan Kesehatan, Vol. 7, No. 2, 2023, hlm. 112–126.

Lestari, F., dan R. Firmansyah. “Pertanggungjawaban Hukum Dokter dalam Tindakan Estetika Medis.” Jurnal Ius Constituendum, Vol. 6, No. 1, 2021, hlm. 88–101.

Mawu, R. “Informed Consent dalam Pelayanan Kesehatan dan Tanggung Jawab Medis.” Lex Administratum, Vol. 6, No. 4, 2018, hlm. 120–128.

Napitupulu, R. “Tanggung Jawab Klinik Kecantikan terhadap Keamanan Produk dan Pelayanan Estetika Medis.” Jurnal Hukum Kesehatan Indonesia, Vol. 2, No. 1, 2020, hlm. 33–41.

Sabri, M. “Tanggung Jawab Hukum Dokter terhadap Pasien akibat Kelalaian Medis.” Jurnal Hukum Kesehatan Indonesia, Vol. 1, No. 2, 2021, hlm. 45–56.

Suryani, D., dan A. Hidayat. “Perlindungan Hukum terhadap Konsumen Jasa Klinik Kecantikan di Indonesia.” Lex Privatum, Vol. 13, No. 2, 2024, hlm. 55–67.

Widjaja, Gunawan, dan Ahmad Yani. Hukum tentang Perlindungan Konsumen. Jakarta: Gramedia Pustaka Utama, 2003.Wibowo, A. “Pertanggungjawaban Hukum Dokter dalam Penggunaan Produk Estetika Medis Ilegal.” Jurnal Hukum Kesehatan dan Etika Medis, Vol. 5, No. 2, 2023, hlm. 88–96.

Books:

Agustina, Rosa. Perbuatan Melawan Hukum. Jakarta: Pascasarjana Fakultas Hukum Universitas Indonesia, 2003.

Badan Pengawas Obat dan Makanan Republik Indonesia. Pedoman Pengawasan Produk Estetika Medis dan Alat Kesehatan. Jakarta: BPOM RI, 2023.

Fuady, Munir. Perbuatan Melawan Hukum: Pendekatan Kontemporer. Bandung: Citra Aditya Bakti, 2013.

Guwandi, J. Hukum Medis dan Rumah Sakit. Jakarta: Balai Penerbit FKUI, 2010.

Hanafiah, M. Jusuf, dan Amri Amir. Etika Kedokteran dan Hukum Kesehatan. Edisi ke-5. Jakarta: EGC, 2017.

Isfandyarie, A. Tanggung Jawab Hukum dan Sanksi bagi Dokter. Jakarta: Prestasi Pustaka, 2006.

Kansil, C. S. T. Pengantar Ilmu Hukum dan Tata Hukum Indonesia. Jakarta: Balai Pustaka, 2006.

Kementerian Kesehatan Republik Indonesia. Peraturan dan Kebijakan Pengawasan Alat Kesehatan dan Produk Estetika Medis. Jakarta: Kementerian Kesehatan RI, 2024.

Kementerian Kesehatan Republik Indonesia. Undang-Undang Nomor 17 Tahun 2023 tentang Kesehatan. Jakarta: Kementerian Kesehatan RI, 2023.

Koeswadji, Hermien Hadiati. Hukum Kedokteran: Studi tentang Hubungan Hukum dalam Mana Dokter sebagai Salah Satu Pihak. Bandung: Citra Aditya Bakti, 2002.

Machmud, S. Penegakan Hukum dan Perlindungan Hukum bagi Dokter yang Diduga Melakukan Malpraktik. Bandung: Mandar Maju, 2008.

Miru, Ahmadi, dan Sutarman Yodo. Hukum Perlindungan Konsumen. Jakarta: RajaGrafindo Persada, 2015

Nasution, Az. Hukum Perlindungan Konsumen: Suatu Pengantar. Jakarta: Diadit Media, 2011.

Nasution, Bahder Johan. Hukum Kesehatan: Pertanggungjawaban Dokter. Jakarta: Rineka Cipta, 2013.

Notoatmodjo, Soekidjo. Etika dan Hukum Kesehatan. Jakarta: Rineka Cipta, 2010.

Sampoerno. Etika dan Hukum Kesehatan. Surabaya: Airlangga University Press, 2011.

Setiawan. Pokok-Pokok Hukum Perikatan. Jakarta: Binacipta, 1999.

Shidarta. Hukum Perlindungan Konsumen Indonesia. Jakarta: Grasindo, 2006.

Soekanto, Soerjono, dan Sri Mamudji. Penelitian Hukum Normatif: Suatu Tinjauan Singkat. Jakarta: RajaGrafindo Persada, 2015.

Subekti. Pokok-Pokok Hukum Perdata. Jakarta: Intermasa, 2005.

Sutrisno, dan Hartono. Tanggung Jawab Perdata dalam Pelayanan Kesehatan. Jakarta: Sinar Grafika, 2011.

Widjaja, Gunawan. Tanggung Jawab Pelaku Usaha dalam Hukum Perlindungan Konsumen. Jakarta: Prenada Media, 2008.

Regulations:

Central Jakarta District Court. Decision Number 734/Pdt.G/2023/PN.Jkt.Pst, July 11, 2024.

Food and Drug Monitoring Agency of the Republic of Indonesia. Regulation of the Food and Drug Monitoring Agency Number 30 of 2020 concerning Technical Requirements for Cosmetic Labeling. State Gazette of the Republic of Indonesia 2020 Number 1623.

Republic of Indonesia. Civil Code (Burgerlijk Wetboek).

Republic of Indonesia. Government Regulation Number 28 of 2024 concerning Implementing Regulations of Law Number 17 of 2023 concerning Health. State Gazette of the Republic of Indonesia 2024 Number 135.

Republic of Indonesia. Law Number 17 of 2023 concerning Health. State Gazette of the Republic of Indonesia 2023 Number 105.

Republic of Indonesia. Law Number 8 of 1999 concerning Consumer Protection. State Gazette of the Republic of Indonesia 1999 Number 42.




DOI: http://dx.doi.org/10.30659/ldj.8.2.570-590

Refbacks

  • There are currently no refbacks.



Law Development Journal has been indexed by:

Editorial Office: RUMAH JURNAL FH UNISSULA (RJFHU) 2nd Floor, Faculty of Law Universitas Islam Sultan Agung. Jln. Kaligawe KM. 4, Semarang City, Central Java, Indonesia. 

Phone: +62 8214461245
Email: ldj@unissula.ac.id

Creative Commons License

LAW DEVELOPMENT JOURNAL (eISSN : 2747-2604), This work is licensed under a Attribution-NonCommercial-NoDerivatives 4.0 International (CC BY-NC-ND 4.0).