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.
The Ministry of Finance this afternoon announced the winning numbers for the March-April uniform invoice lottery. The winning number for the NT$10 million (US$318,060) special prize is 19531471, and the winning number for the NT$2 million grand prize is 85941329. Three numbers were drawn for the NT$200,000 first prize: 07225810, 20231230 and 83518781. Those with receipts matching the last seven digits of any of the first-prize numbers will win the NT$40,000 second prize, while those matching the last six digits will win the NT$10,000 third prize. Those whose receipts match the last five digits of the first-prize numbers can claim the NT$4,000 fourth prize,
SIX SUBSIDIES: The monthly allowance for older farmers is to increase to NT$10,000, and NT$5,000 is to be given to homemakers under the national pension system, Lai said The government is to implement major welfare policies for disadvantaged groups, including raising the monthly allowance for older farmers to NT$10,000 and providing homemakers with NT$5,000 per month, President William Lai (賴清德) said yesterday. Lai made the remarks during a visit to Wangling Temple in Chiayi County, saying that the planned increases were being introduced amid economic growth and an increase in tax revenue. Touting a policy, in which the government plans to provide a monthly allowance of NT$5,000 for every child under the age of 18 in a bid to address Taiwan’s low birthrate, Lai said that if received for the
STAY COOL: The HPA recommended that people stay hydrated, use air-conditioning or fans while indoors, wear loose-fitting clothes and walk in the shade while outdoors Employers must implement measures such as installing cooling equipment, and providing drinking water and rest breaks for outdoor workers starting from Monday next week, the Taipei Department of Labor said on Sunday. Employers who fail to comply could face fines of NT$30,000 to NT$300,000 under the Occupational Safety and Health Act (職業安全衛生法), the department said. Businesses in Taipei employing fewer than 100 workers, as well as registered self-employed workers with labor insurance coverage, could receive on-site assessments and guidance from occupational safety consultants to help them apply for central government subsidies to implement or improve heat-protection measures, it said. Under the Ministry of
ISOLATION: The outposts would serve as support and backup bases, forcing US forces to either face China head-on or reroute, increasing travel time and operational costs China’s outposts in the South China Sea could be used to delay and constrain foreign forces during a conflict in the Taiwan Strait, giving Beijing a critical window to carry out amphibious landing and blockade operations, a report said. The Chinese Communist Party’s (CCP) forward operating bases on islands and reclaimed features in the South China Sea could delay foreign forces long enough for the Chinese People’s Liberation Army (PLA) to secure a key 48-to-72-hour window in the Taiwan Strait, a report commissioned by the Mainland Affairs Council found. The report, conducted by the Institute for National Defense and Security Research, examined
RSS