Democratic Progressive Party Legislator Lin Shu-fen (林淑芬) and Women’s Link founder Huang Sue-ying (黃淑英) yesterday called on the government to ban transvaginal mesh implants and establish a registry system for medical implants.
Transvaginal mesh implants are used to repair weakened or damaged tissue in women’s bladder or pelvic areas, usually in cases of pelvic organ prolapse (POP) or stress urinary incontinence (SUI).
The US Food and Drug Administration (FDA) cleared the first surgical mesh product specifically for use in SUI cases in 1996 and for POP cases in 2002.
Photo: Tu Chien-jung, Taipei Times
However, complications including chronic pain, vaginal bleeding or discharge, pain during intercourse, urinary problems and exposure of the mesh through the vagina have been reported in many nations, triggering lawsuits in several countries.
New Zealand and Australia last year banned the use of the implants, while the UK enacted a temporary ban, and in April, the FDA ordered manufacturers to immediately stop selling and distributing surgical mesh for anterior compartment prolapse repair, citing safety concerns, Huang told a news conference at the Legislative Yuan in Taipei.
“Compared with the proactive measures taken in other nations, Taiwan is still silent on the issue,” she said.
The Ministry of Health and Welfare only changed the classification of transvaginal mesh to a third-class “high-risk” medical device in July 2017, requiring manufacturers to submit a safety report on their products every six months, Huang said.
“The government is very irresponsible. Its relaxed attitude toward regulating the manufacturers, neglecting the health risks to women who have had such implant surgery,” Lin said.
Reports of complications associated with transvaginal meshes in Taiwan increased from 59 cases in 2013 to 303 cases in 2017, and some patients might not even be aware that their discomfort could be the result of complications caused by the implants, she said.
The government needs to establish a medical implant registry system, and require that patients be informed about the possible risks associated with transvaginal meshes before having such surgeries.
Food and Drug Administration section chief Tu Pei-weng (杜培文) said the agency was aware of international safety warnings about the products and had adjusted the risk management measures on such implants.
However, a meeting of specialists that the agency held in March suggested that the reported problems in Taiwan stemming from such procedures were more due to physicians’ training and patient screening than with the products, she said.
The specialists at the meeting said that banning the use of transvaginal mesh implants would hurt women with SUI or POP, as there is no better alternative treatment, Tu said.
Given patient personal data protection regulations, registry systems are usually voluntary, not compulsory, she said.
An amendment to the Regulations for Governing the Management of Medical Devices (醫療器材管理法) that is under review at the Legislative Yuan would require the tracking of high-risk medical devices from the manufacturers, Taiwan’s Food and Drug Administration said.
Proposed legislation in the US outlines three conditions in which Washington would be authorized to protect Taiwan were China to invade, a report said yesterday. US Representative Ted Yoho this month said he would introduce a Taiwan Invasion Prevention Act, which would authorize US military force if China were to invade Taiwan-controlled areas, including its outlying islands. According to a version of the bill obtained by the Chinese-language Liberty Times (the sister paper of the Taipei Times), the bill lists three conditions in which a US president would be authorized to use military force to protect Taiwan: If China uses military force
The Supreme Court on Tuesday found four men guilty of attempted murder in the 2017 stabbing of Spanish surfer Ignacio Prio on a Pingtung County beach in the final ruling in the case, sentencing them to three-and-a-half to six years in prison. The defendants had appealed their convictions for attempted murder in the first and second rulings, which had also led to prison sentences ranging from three-and-a-half years to six years. The then-42-year-old Prio went to Jialeshui Beach (佳樂水) near Kenting (墾丁) on March 31, 2017, was attacked after he asked four men to remove their fishing lines from an area
Two new commuter trains are scheduled to be launched in January next year, the Taiwan Railways Administration (TRA) said yesterday. The acquisition of EMU-900 commuter train cars is part of the railway operator’s plan to replace 589 train cars that have been in operation for more than three decades. The agency has also placed orders to buy 600 intercity train cars. The first batch of 20 EMU-900 cars is to be delivered to the nation in September, although delivery might be delayed until October due to the COVID-19 pandemic, the agency said. The batch would be formed into two trains of 10
‘IMMORAL, INSINCERE’: Huang Kun-huei said that Ma was ‘distorting history’ in claiming that Lee Teng-hui laid the foundation for the so-called ‘1992 consensus’ Former Presidential Office secretary-general Huang Kun-huei (黃昆輝) on Saturday rejected former president Ma Ying-jeou’s (馬英九) claim that former president Lee Teng-hui (李登輝) had been a proponent of Beijing’s “one China” principle. Lee, who served as president from 1988 to 2000, died in Taipei on Thursday last week. After visiting the Taipei Guest House on Saturday to pay his respects to Lee, Ma posted on Facebook that “28 years ago on this day” Lee hosted a session of the now-defunct National Unification Council, during which he passed a resolution on the “one China” principle. That resolution became the basis of the Chinese Nationalist Party’s