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FDA OKs first condom for anal sex
specifically designed for use during anal sex has gained Food and Drug Administration approval.
Anal intercourse is considered to be much riskier than vaginal sex for the transmission of infections such as HIV and HPV, a risk factor for anal cancer, agency officials said in a statement Feb. 23 announcing the decision. And though the Centers for Disease Control and Prevention has long encouraged the use of a condom during anal intercourse, the FDA had not until now deemed this practice safe.
The latex ONE Male Condom, from prophylactic maker Global Protection Corp. of Boston, has already been available for vaginal sex. The FDA action now allows the company to market the product for anal intercourse.
“This authorization helps us accomplish our priority to advance health equity through the development of safe and effective products that meet the needs of diverse populations,” Courtney Lias, PhD, the director of the FDA’s Office of GastroRenal, ObGyn, General Hospital, and Urology Devices, said in a statement.
The FDA said it relied on an Emory University clinical study of condom safety of more than 500 men. Those who took part in the study were evenly divided between men who have sex with men and men who have sex with women. The condom failure rate, meaning that a condom either broke or slipped, was less than 1% during anal sex. The failure rate was 3 times higher during vaginal intercourse.
The Emory researchers also found that roughly 70% of men who have sex with men would be more likely to use condoms marked as safe for anal sex, according to a survey of 10,000 people.
ONE Male Condoms sell for between $3.48 for a three-pack and $14.48 for a 24-pack, according to Milla Impola, Global Protection’s director of marketing and communications. The FDA said the condom should be used with a condom-compatible lubricant when used during anal sex.
A version of this article first appeared on WebMD.com.
specifically designed for use during anal sex has gained Food and Drug Administration approval.
Anal intercourse is considered to be much riskier than vaginal sex for the transmission of infections such as HIV and HPV, a risk factor for anal cancer, agency officials said in a statement Feb. 23 announcing the decision. And though the Centers for Disease Control and Prevention has long encouraged the use of a condom during anal intercourse, the FDA had not until now deemed this practice safe.
The latex ONE Male Condom, from prophylactic maker Global Protection Corp. of Boston, has already been available for vaginal sex. The FDA action now allows the company to market the product for anal intercourse.
“This authorization helps us accomplish our priority to advance health equity through the development of safe and effective products that meet the needs of diverse populations,” Courtney Lias, PhD, the director of the FDA’s Office of GastroRenal, ObGyn, General Hospital, and Urology Devices, said in a statement.
The FDA said it relied on an Emory University clinical study of condom safety of more than 500 men. Those who took part in the study were evenly divided between men who have sex with men and men who have sex with women. The condom failure rate, meaning that a condom either broke or slipped, was less than 1% during anal sex. The failure rate was 3 times higher during vaginal intercourse.
The Emory researchers also found that roughly 70% of men who have sex with men would be more likely to use condoms marked as safe for anal sex, according to a survey of 10,000 people.
ONE Male Condoms sell for between $3.48 for a three-pack and $14.48 for a 24-pack, according to Milla Impola, Global Protection’s director of marketing and communications. The FDA said the condom should be used with a condom-compatible lubricant when used during anal sex.
A version of this article first appeared on WebMD.com.
specifically designed for use during anal sex has gained Food and Drug Administration approval.
Anal intercourse is considered to be much riskier than vaginal sex for the transmission of infections such as HIV and HPV, a risk factor for anal cancer, agency officials said in a statement Feb. 23 announcing the decision. And though the Centers for Disease Control and Prevention has long encouraged the use of a condom during anal intercourse, the FDA had not until now deemed this practice safe.
The latex ONE Male Condom, from prophylactic maker Global Protection Corp. of Boston, has already been available for vaginal sex. The FDA action now allows the company to market the product for anal intercourse.
“This authorization helps us accomplish our priority to advance health equity through the development of safe and effective products that meet the needs of diverse populations,” Courtney Lias, PhD, the director of the FDA’s Office of GastroRenal, ObGyn, General Hospital, and Urology Devices, said in a statement.
The FDA said it relied on an Emory University clinical study of condom safety of more than 500 men. Those who took part in the study were evenly divided between men who have sex with men and men who have sex with women. The condom failure rate, meaning that a condom either broke or slipped, was less than 1% during anal sex. The failure rate was 3 times higher during vaginal intercourse.
The Emory researchers also found that roughly 70% of men who have sex with men would be more likely to use condoms marked as safe for anal sex, according to a survey of 10,000 people.
ONE Male Condoms sell for between $3.48 for a three-pack and $14.48 for a 24-pack, according to Milla Impola, Global Protection’s director of marketing and communications. The FDA said the condom should be used with a condom-compatible lubricant when used during anal sex.
A version of this article first appeared on WebMD.com.
Malpractice suits against ob.gyns. continue downward trend
Nearly 80% of obstetrician-gynecologists report having been named in at least one malpractice claim, but the total number who report such suits has fallen steadily since 2017, according to the Medscape Ob/Gyn Malpractice Report 2021.
Ob.gyns. were the fifth most likely among practitioners in 29 specialties to be sued, and they are much more likely than are the typical physicians to be parties to a malpractice case (51%), according to the new report. However, the number of ob.gyns. who reported a malpractice suit has been dropping, from 85% in 2017 to 83% in 2019 to 79% in 2021. In most cases, multiple parties were named in the lawsuit (64%), although 27% of ob.gyns. reported having been sued individually.
The most common reasons for lawsuits were complications from treatment/surgery (39%), poor outcome/disease progression (30%), failure to diagnose/delayed diagnosis (25%), patients suffering an abnormal injury (17%), and failure to treat/delayed treatment (16%).
The 2021 report was compiled from an online survey that included more than 4,300 physicians representing 29 specialties; the survey was available from May 21 to Aug. 28, 2021. Respondents include 314 ob.gyns. Most respondents had been in practice at least 25 years (60%), and 55% were at least 60 years old.
Ob.gyns. carry higher malpractice insurance costs than nearly every other medical specialty, owing to the unique challenges and inherent risks of delivering newborn babies. In 2021, 33% of ob.gyns. reported paying at least $30,000 in annual premiums, and only 27% said they paid less than $20,000. Over half of all specialists (52%) paid less than $20,000 in annual insurance premiums.
More than 70% of ob.gyns. were “very” (32%) or “somewhat” surprised (40%) by their malpractice suits. A large majority said they believed the lawsuit was unwarranted (78%). One respondent wrote: “Feeling like I had done my best for the patient and she sued me anyway.”
Many cases settled before trial (40%), although some (12%) were still in process at the time of the survey. Other outcomes ranged from a judge or jury ruling on behalf of the physician (8%) or the lawsuit being dismissed within a few months of filing (8%). Ob.gyns. reported having lost 2% the suits.
The largest proportion of cases took less than 2 years (39%), although almost as many cases (33%) lasted between 3 and 5 years. Monetary awards to plaintiffs exceeded $1 million in 15% of cases that resulted in economic damages, with 8% of these awards exceeding $2 million. One in five awards were between $500,000 and $1 million.
Most ob.gyns. (67%) said the lawsuits did not negatively affect their careers. Roughly one in five ob.gyns. (21%) said they now trusted their patients less than they did before the suit, modestly fewer than specialists overall (24%).
The largest proportion of ob.gyns. (44%) said they would not have done anything differently, almost identical to the proportion of physicians overall (43%). Approximately 10% of ob.gyns. said they would never have taken the patient in the first place, while 9% said they should have developed better chart documentation, and 8% said they should have referred the patient to another physician.
A version of this article first appeared on Medscape.com.
Nearly 80% of obstetrician-gynecologists report having been named in at least one malpractice claim, but the total number who report such suits has fallen steadily since 2017, according to the Medscape Ob/Gyn Malpractice Report 2021.
Ob.gyns. were the fifth most likely among practitioners in 29 specialties to be sued, and they are much more likely than are the typical physicians to be parties to a malpractice case (51%), according to the new report. However, the number of ob.gyns. who reported a malpractice suit has been dropping, from 85% in 2017 to 83% in 2019 to 79% in 2021. In most cases, multiple parties were named in the lawsuit (64%), although 27% of ob.gyns. reported having been sued individually.
The most common reasons for lawsuits were complications from treatment/surgery (39%), poor outcome/disease progression (30%), failure to diagnose/delayed diagnosis (25%), patients suffering an abnormal injury (17%), and failure to treat/delayed treatment (16%).
The 2021 report was compiled from an online survey that included more than 4,300 physicians representing 29 specialties; the survey was available from May 21 to Aug. 28, 2021. Respondents include 314 ob.gyns. Most respondents had been in practice at least 25 years (60%), and 55% were at least 60 years old.
Ob.gyns. carry higher malpractice insurance costs than nearly every other medical specialty, owing to the unique challenges and inherent risks of delivering newborn babies. In 2021, 33% of ob.gyns. reported paying at least $30,000 in annual premiums, and only 27% said they paid less than $20,000. Over half of all specialists (52%) paid less than $20,000 in annual insurance premiums.
More than 70% of ob.gyns. were “very” (32%) or “somewhat” surprised (40%) by their malpractice suits. A large majority said they believed the lawsuit was unwarranted (78%). One respondent wrote: “Feeling like I had done my best for the patient and she sued me anyway.”
Many cases settled before trial (40%), although some (12%) were still in process at the time of the survey. Other outcomes ranged from a judge or jury ruling on behalf of the physician (8%) or the lawsuit being dismissed within a few months of filing (8%). Ob.gyns. reported having lost 2% the suits.
The largest proportion of cases took less than 2 years (39%), although almost as many cases (33%) lasted between 3 and 5 years. Monetary awards to plaintiffs exceeded $1 million in 15% of cases that resulted in economic damages, with 8% of these awards exceeding $2 million. One in five awards were between $500,000 and $1 million.
Most ob.gyns. (67%) said the lawsuits did not negatively affect their careers. Roughly one in five ob.gyns. (21%) said they now trusted their patients less than they did before the suit, modestly fewer than specialists overall (24%).
The largest proportion of ob.gyns. (44%) said they would not have done anything differently, almost identical to the proportion of physicians overall (43%). Approximately 10% of ob.gyns. said they would never have taken the patient in the first place, while 9% said they should have developed better chart documentation, and 8% said they should have referred the patient to another physician.
A version of this article first appeared on Medscape.com.
Nearly 80% of obstetrician-gynecologists report having been named in at least one malpractice claim, but the total number who report such suits has fallen steadily since 2017, according to the Medscape Ob/Gyn Malpractice Report 2021.
Ob.gyns. were the fifth most likely among practitioners in 29 specialties to be sued, and they are much more likely than are the typical physicians to be parties to a malpractice case (51%), according to the new report. However, the number of ob.gyns. who reported a malpractice suit has been dropping, from 85% in 2017 to 83% in 2019 to 79% in 2021. In most cases, multiple parties were named in the lawsuit (64%), although 27% of ob.gyns. reported having been sued individually.
The most common reasons for lawsuits were complications from treatment/surgery (39%), poor outcome/disease progression (30%), failure to diagnose/delayed diagnosis (25%), patients suffering an abnormal injury (17%), and failure to treat/delayed treatment (16%).
The 2021 report was compiled from an online survey that included more than 4,300 physicians representing 29 specialties; the survey was available from May 21 to Aug. 28, 2021. Respondents include 314 ob.gyns. Most respondents had been in practice at least 25 years (60%), and 55% were at least 60 years old.
Ob.gyns. carry higher malpractice insurance costs than nearly every other medical specialty, owing to the unique challenges and inherent risks of delivering newborn babies. In 2021, 33% of ob.gyns. reported paying at least $30,000 in annual premiums, and only 27% said they paid less than $20,000. Over half of all specialists (52%) paid less than $20,000 in annual insurance premiums.
More than 70% of ob.gyns. were “very” (32%) or “somewhat” surprised (40%) by their malpractice suits. A large majority said they believed the lawsuit was unwarranted (78%). One respondent wrote: “Feeling like I had done my best for the patient and she sued me anyway.”
Many cases settled before trial (40%), although some (12%) were still in process at the time of the survey. Other outcomes ranged from a judge or jury ruling on behalf of the physician (8%) or the lawsuit being dismissed within a few months of filing (8%). Ob.gyns. reported having lost 2% the suits.
The largest proportion of cases took less than 2 years (39%), although almost as many cases (33%) lasted between 3 and 5 years. Monetary awards to plaintiffs exceeded $1 million in 15% of cases that resulted in economic damages, with 8% of these awards exceeding $2 million. One in five awards were between $500,000 and $1 million.
Most ob.gyns. (67%) said the lawsuits did not negatively affect their careers. Roughly one in five ob.gyns. (21%) said they now trusted their patients less than they did before the suit, modestly fewer than specialists overall (24%).
The largest proportion of ob.gyns. (44%) said they would not have done anything differently, almost identical to the proportion of physicians overall (43%). Approximately 10% of ob.gyns. said they would never have taken the patient in the first place, while 9% said they should have developed better chart documentation, and 8% said they should have referred the patient to another physician.
A version of this article first appeared on Medscape.com.
Missed diagnosis common source of malpractice claims against PCPs
, according to the Medscape Primary Care Physician Malpractice Report 2021. This figure is less than the overall proportion of physicians in all specialties named in a malpractice suit (51%).
More PCPs were part of lawsuits that named multiple parties (34%) than suits that named a individual practitioners (11%). Failure to make a proper diagnosis (41%) was the most common claim in malpractice suits against PCPs, followed by poor outcome/disease progression (26%), complications from treatment/surgery (17%), wrongful death (16%), and failure to treat/delayed treatment (16%).
The report was compiled from an online survey that included more than 4,300 physicians from 29 specialties. The survey was available from May 21, 2021, to August 28, 2021, and included 732 family and internal medicine physicians. Most respondents had practiced medicine for more than 25 years (47%) or from 21-25 years (16%). Almost half of respondents (47%) were aged 60 years or older.
Most PCPs (63%) reported malpractice insurance premiums of less than $20,000 per year, which is more than the overall proportion for all specialists (52%). The typical premium for PCPs was $5,000-$9,999 (26%). Premium payments varied widely by geographic area, with a PCP in New York paying five times as much as a colleague in California, Tennessee, or Ohio would pay to obtain comparable coverage, the survey found.
More than 9 in 10 PCPs (91%) reported being “very surprised” or “somewhat surprised” to having been part of a malpractice suit and reported being upset and anxious: “Feeling betrayed by people to whom I had provided good care, and embarrassed that my colleagues might find out,” as one internist put it. The majority (84%) of PCPs said their lawsuits were unwarranted, in line with perceptions among all specialists (83%).
The largest proportions of cases were settled before trial (35%) or were dismissed within a few months of lawsuit filing (16%). A judge or jury ruled in the plaintiff’s favor only 2% of the time. Seven percent of cases are ongoing, and 3% were settled at trial, according to the survey.
The largest number of cases (40%) took between 1 and 2 years, although 30% were less than a year. Roughly one in four cases (24%) lasted 3-5 years. Almost half (47%) of any monetary payments to plaintiffs were $100,000 or less; one-third of such payments were capped at $500,000.
Two-thirds (68%) of PCPs said that the lawsuit did not negatively affect their careers, and more than one in four (28%) said they now no longer trust patients or that they treat them differently. This change in trust is slightly higher than for specialists overall (24%).
More than 4 in 10 PCPs (41%) said they would have done nothing differently despite being sued. The largest proportion of changes other PCPs would have made included improved documentation (18%) and ordering additional tests as a hedge against a lawsuit (11%); 10% said they should never have taken on the patient in the first place.
A version of this article first appeared on Medscape.com.
, according to the Medscape Primary Care Physician Malpractice Report 2021. This figure is less than the overall proportion of physicians in all specialties named in a malpractice suit (51%).
More PCPs were part of lawsuits that named multiple parties (34%) than suits that named a individual practitioners (11%). Failure to make a proper diagnosis (41%) was the most common claim in malpractice suits against PCPs, followed by poor outcome/disease progression (26%), complications from treatment/surgery (17%), wrongful death (16%), and failure to treat/delayed treatment (16%).
The report was compiled from an online survey that included more than 4,300 physicians from 29 specialties. The survey was available from May 21, 2021, to August 28, 2021, and included 732 family and internal medicine physicians. Most respondents had practiced medicine for more than 25 years (47%) or from 21-25 years (16%). Almost half of respondents (47%) were aged 60 years or older.
Most PCPs (63%) reported malpractice insurance premiums of less than $20,000 per year, which is more than the overall proportion for all specialists (52%). The typical premium for PCPs was $5,000-$9,999 (26%). Premium payments varied widely by geographic area, with a PCP in New York paying five times as much as a colleague in California, Tennessee, or Ohio would pay to obtain comparable coverage, the survey found.
More than 9 in 10 PCPs (91%) reported being “very surprised” or “somewhat surprised” to having been part of a malpractice suit and reported being upset and anxious: “Feeling betrayed by people to whom I had provided good care, and embarrassed that my colleagues might find out,” as one internist put it. The majority (84%) of PCPs said their lawsuits were unwarranted, in line with perceptions among all specialists (83%).
The largest proportions of cases were settled before trial (35%) or were dismissed within a few months of lawsuit filing (16%). A judge or jury ruled in the plaintiff’s favor only 2% of the time. Seven percent of cases are ongoing, and 3% were settled at trial, according to the survey.
The largest number of cases (40%) took between 1 and 2 years, although 30% were less than a year. Roughly one in four cases (24%) lasted 3-5 years. Almost half (47%) of any monetary payments to plaintiffs were $100,000 or less; one-third of such payments were capped at $500,000.
Two-thirds (68%) of PCPs said that the lawsuit did not negatively affect their careers, and more than one in four (28%) said they now no longer trust patients or that they treat them differently. This change in trust is slightly higher than for specialists overall (24%).
More than 4 in 10 PCPs (41%) said they would have done nothing differently despite being sued. The largest proportion of changes other PCPs would have made included improved documentation (18%) and ordering additional tests as a hedge against a lawsuit (11%); 10% said they should never have taken on the patient in the first place.
A version of this article first appeared on Medscape.com.
, according to the Medscape Primary Care Physician Malpractice Report 2021. This figure is less than the overall proportion of physicians in all specialties named in a malpractice suit (51%).
More PCPs were part of lawsuits that named multiple parties (34%) than suits that named a individual practitioners (11%). Failure to make a proper diagnosis (41%) was the most common claim in malpractice suits against PCPs, followed by poor outcome/disease progression (26%), complications from treatment/surgery (17%), wrongful death (16%), and failure to treat/delayed treatment (16%).
The report was compiled from an online survey that included more than 4,300 physicians from 29 specialties. The survey was available from May 21, 2021, to August 28, 2021, and included 732 family and internal medicine physicians. Most respondents had practiced medicine for more than 25 years (47%) or from 21-25 years (16%). Almost half of respondents (47%) were aged 60 years or older.
Most PCPs (63%) reported malpractice insurance premiums of less than $20,000 per year, which is more than the overall proportion for all specialists (52%). The typical premium for PCPs was $5,000-$9,999 (26%). Premium payments varied widely by geographic area, with a PCP in New York paying five times as much as a colleague in California, Tennessee, or Ohio would pay to obtain comparable coverage, the survey found.
More than 9 in 10 PCPs (91%) reported being “very surprised” or “somewhat surprised” to having been part of a malpractice suit and reported being upset and anxious: “Feeling betrayed by people to whom I had provided good care, and embarrassed that my colleagues might find out,” as one internist put it. The majority (84%) of PCPs said their lawsuits were unwarranted, in line with perceptions among all specialists (83%).
The largest proportions of cases were settled before trial (35%) or were dismissed within a few months of lawsuit filing (16%). A judge or jury ruled in the plaintiff’s favor only 2% of the time. Seven percent of cases are ongoing, and 3% were settled at trial, according to the survey.
The largest number of cases (40%) took between 1 and 2 years, although 30% were less than a year. Roughly one in four cases (24%) lasted 3-5 years. Almost half (47%) of any monetary payments to plaintiffs were $100,000 or less; one-third of such payments were capped at $500,000.
Two-thirds (68%) of PCPs said that the lawsuit did not negatively affect their careers, and more than one in four (28%) said they now no longer trust patients or that they treat them differently. This change in trust is slightly higher than for specialists overall (24%).
More than 4 in 10 PCPs (41%) said they would have done nothing differently despite being sued. The largest proportion of changes other PCPs would have made included improved documentation (18%) and ordering additional tests as a hedge against a lawsuit (11%); 10% said they should never have taken on the patient in the first place.
A version of this article first appeared on Medscape.com.