FDA takes action to protect women’s health, orders manufacturers of surgical mesh intended for transvaginal repair of pelvic organ prolapse to stop selling all devices
April 16, 2019 – The U.S. Food and Drug Administration today ordered the manufacturers of all remaining surgical mesh products indicated for the transvaginal repair of pelvic organ prolapse (POP) to stop selling and distributing their products in the U.S. immediately. The order is the latest in a series of escalating safety actions related to protecting the health of the thousands of women each year who undergo surgery transvaginally to repair POP.
The FDA has determined that the manufacturers, Boston Scientific and Coloplast, have not demonstrated a reasonable assurance of safety and effectiveness for these devices, which is the premarket review standard that now applies to them since the agency reclassified them in class III (high risk) in 2016. As part of the 2016 reclassification, manufacturers were required to submit and obtain approval of premarket approval (PMA) applications, the agency’s most stringent device review pathway, in order to continue marketing their devices in the U.S. The companies will have 10 days to submit their plan to withdraw these products from the market.
… continue reading the FDA press announcement.
Read the meshCNN press release. Image credit leakylily.
In the UK
The Food and Drug Administration has let medical device companies file reports of injuries and malfunctions outside a widely scrutinized public database, which leave doctors and medical sleuths in the dark
Kaiser Health News senior correspondent Christina Jewett explains how she investigated a Food and Drug Administration database where medical device makers report malfunctions and patient injuries, skirting the public record. Because the cache of information is buried deep within the agency, it’s often hard for physicians, researchers and patient safety advocates to access the information.
Largest-Ever Study Shows Silicone Breast Implants Associated with Rare Diseases
In the largest study of long-term safety outcomes for patients with breast implants, researchers at The University of Texas MD Anderson Cancer Center have found that silicone implants are associated with some rare diseases, autoimmune disorders and other conditions.
To analyze the long-term safety and efficacy outcomes of patients with breast implants.
Summary Background Data:
Research is ongoing regarding the safety of silicone breast implants. Despite the number of patients with breast implants followed by United States Food and Drug Administration large postapproval studies (LPAS), this database has not been thoroughly analyzed or reported.
This is a multicentered, cohort study. LPAS prospectively monitor long-term implant-related outcomes and systemic harms for silicone/saline implants from 2 manufacturers (Allergan and Mentor) placed for primary/revision augmentation/reconstruction. Systemic harms, self-harm, and reproductive outcomes are compared with normative data. Implant-related complications are analyzed by implant composition and operative indication in the short and long terms.
LPAS data includes 99,993 patients, 56% of implants were silicone for primary augmentation. Long-term magnetic resonance imaging surveillance is under 5%. Compared with normative data, silicone implants are associated with higher rates of Sjogren syndrome (Standardized incidence ratio [SIR]8.14), scleroderma (SIR 7.00), rheumatoid arthritis (SIR5.96), stillbirth (SIR4.50), and melanoma (SIR3.71). One case of BI-ALCL is reported. There is no association with suicide. In the short term, rupture is higher for saline (2.5% vs. 0.5%, P < 0.001), and capsular contracture higher for silicone (5.0% vs. 2.8%, P < 0.001). At 7 years, reoperation rate is 11.7% for primary augmentation, and 25% for primary/revision reconstruction. Capsular contracture (III/IV) occurs in 7.2% of primary augmentations, 12.7% primary reconstructions, and is the most common reason for reoperation among augmentations.
This is the largest study of breast implant outcomes. Silicone implants are associated with an increased risk of certain rare harms; associations need to be further analyzed with patient-level data to provide conclusive evidence. Long-term safety and implant-related outcomes should inform patient and surgeon decision-making when selecting implants.
Reference. Press release.
The latest Instagram influencer frontier? Medical promotions
“By enlisting influencers to market their health care products amid a stream of Facetuned photos, pharmaceutical and biotechnology companies co-opt narratives that give social media users a sense of how healthy they can be, if only they had this product.”
“Social media enables its users to connect over shared interests, locations, and even illnesses. Using this formula, health care companies locate potential influencers who can use these commonalities to reach and build trust with an audience.”
“One wonders why a company would assume the risk of misinformed patients, as they are responsible for what their paid endorsers say. The reason is simple: One in three consumers in the US consult social media for health-related matters. “
Read The latest Instagram influencer frontier? Medical promotions, on vox, Feb 15, 2019.
Massive legal loophole means companies can add new ingredients to foods with no government safety review
The industry can declare on their own that added ingredients are safe without ever consulting the Food and Drug Administration about potential health risks.
References : publicintegrity and belowthesaltnews, 2015.
Dr Frances Oldham Kelsey : 20th-century American heroine for her role in the Thalidomide case
In 1960, Frances Kelsey was one of the Food and Drug Administration’s newest recruits. Before the year was out, she would begin a fight that would save thousands of lives — though no one knew it at the time.
- Andrea Tone explains how Kelsey was able to prevent a massive national public health tragedy by privileging facts over opinions, and patience over shortcuts.
- Video published on 7 June 2018 by TED-Ed.
Chemicals in Food May Harm Children, Pediatricians’ Group Says
In their Policy Statement and Technical Report, the American Academy of Pediatrics is urging families to limit the use of plastic food containers, cut down on processed meat during pregnancy and consume more whole fruits and vegetables rather than processed food.
Such measures would lower children’s exposures to chemicals in food and food packaging that are tied to health problems such as obesity, Roni Caryn Rabin reports. Featured image credit Fernanda Rodríguez.
2018 Policy Statement Abstract
Our purposes with this policy statement and its accompanying technical report are to review and highlight emerging child health concerns related to the use of colorings, flavorings, and chemicals deliberately added to food during processing (direct food additives) as well as substances in food contact materials, including adhesives, dyes, coatings, paper, paperboard, plastic, and other polymers, which may contaminate food as part of packaging or manufacturing equipment (indirect food additives); to make reasonable recommendations that the pediatrician might be able to adopt into the guidance provided during pediatric visits; and to propose urgently needed reforms to the current regulatory process at the US Food and Drug Administration (FDA) for food additives. Concern regarding food additives has increased in the past two decades, in part because of studies in which authors document endocrine disruption and other adverse health effects. In some cases, exposure to these chemicals is disproportionate among minority and low-income populations. Regulation and oversight of many food additives is inadequate because of several key problems in the Federal Food, Drug, and Cosmetic Act. Current requirements for a “generally recognized as safe” (GRAS) designation are insufficient to ensure the safety of food additives and do not contain sufficient protections against conflict of interest. Additionally, the FDA does not have adequate authority to acquire data on chemicals on the market or reassess their safety for human health. These are critical weaknesses in the current regulatory system for food additives. Data about health effects of food additives on infants and children are limited or missing; however, in general, infants and children are more vulnerable to chemical exposures. Substantial improvements to the food additives regulatory system are urgently needed, including greatly strengthening or replacing the “generally recognized as safe” (GRAS) determination process, updating the scientific foundation of the FDA’s safety assessment program, retesting all previously approved chemicals, and labeling direct additives with limited or no toxicity data.
Testosterone Prescribing in the United States, 2002-2016
Testosterone use in the United States tripled from 2001 through 2011, mostly in men without a clear indication.
In late 2013 and early 2014, two studies reported increased myocardial infarction and stroke associated with testosterone use.
The US Food and Drug Administration (FDA) issued a safety bulletin on January 31, 2014.
After a decade of growth, the percentage of US men receiving testosterone prescriptions decreased from 2013, falling to less than 2% of men by 2016.
This prescribing trends study was published July 10, 2018.
Fake And Faulty Drugs: A Problem No One Wants To Talk About
The explosion of Internet commerce, coupled with globalization and increased pharmaceutical use has led to an unprecedented vulnerability in the U.S. drug supply. Today, an estimated 80% of our drugs are manufactured overseas, mostly in India and China. Every link along this supply chain offers an opportunity for counterfeiters, and increasingly, they are breaking in. In 2008, fake doses of the blood thinner Heparin killed 81 people worldwide and resulted in hundreds of severe allergic reactions in the United States. In 2012, a counterfeit version of the cancer drug Avastin, containing no active chemotherapy ingredient, was widely distributed in the United States. In early 2013, a drug trafficker named Francis Ortiz Gonzalez was sentenced to prison for distributing an assortment of counterfeit, Chinese-made pharmaceuticals across America. By the time he was arrested, he had already sold over 140,000 fake pills to customers.
Even when the U.S. system works, as it mostly does, consumers are increasingly circumventing the safeguards. Skyrocketing health care costs in the U.S. have forced more Americans to become “medical tourists” seeking drugs, life-saving treatments and transplants abroad, sometimes in countries with rampant counterfeit drug problems and no FDA.
Increased incidence of cervical cancer in Sweden : Possible link with HPV vaccination
Recently, when the Swedish media discussed the increase in the incidence of cervical cancer, the health authorities were unable to explain the increase.
2018 Study Abstract
The Centre for Cervical Cancer Prevention in Sweden has noted in its annual report a substantial increase in the incidence of invasive cervical cancer, especially during the two years 2014 and 2015. I have sub-grouped the data according to age, using the same statistical database of the National Board of Health and Welfare as used by the authors of the above-mentioned report. The increase in the incidence of cervical cancer was shown to be most prominent among women 20–49 years of age while no apparent increase was observed among women above 50. The FDA has noted in the clinical trials referred to it for marketing approval that women exposed to the human papilloma virus (HPV) prior to vaccination had an increase in premalignant cell changes compared with placebo controls. I discuss the possibility that HPV vaccination could play a role in the increase in the incidence of cervical cancer by causing instead of preventing cervical cancer disease in women previously exposed to HPV. A time relationship exists between the start of vaccination and the increase in the incidence of cervical cancer. The HPV vaccines were approved in 2006 and 2007, respectively and most young girls started to be vaccinated during 2012–2013.
Featured image credit ijme shows increase in incidence of cervical cancer among younger women (<50 years) as compared with women ≥50 years. The data shows the number of cases/100,000 women from 2006 to 2015.