Concomitant Hysterectomy Ups Risk of Mesh Extrusion

BALTIMORE – Concomitant hysterectomy increases the risk of mesh extrusion in pelvic reconstructive surgery by more than fivefold, according to the results of a retrospective case-control study of women undergoing abdominal sacral colpopexy or vaginal mesh procedures.

"This is a very timely and important research topic, especially given the recent [Food and Drug Administration] advisory," said Dr. Nazanin Ehsani, who presented the results at the annual meeting of the Society of Gynecologic Surgeons.

In 2008 and again in 2011, the FDA issued warnings about the use of transvaginal mesh. The 2011 warning was issued to inform health care professionals that serious complications associated with surgical mesh for transvaginal repair of pelvic organ prolapse (POP) are not rare. The agency also noted that it is not clear that transvaginal repair with mesh is more effective than traditional non-mesh repair in all patients with POP, and it may expose patients to greater risk.

On multivariate analysis, concomitant hysterectomy was associated with an increased risk of mesh extrusion compared with no hysterectomy (odds ratio, 5.97; P = .003). Previous hysterectomy showed a trend toward increased risk of mesh extrusion compared with no hysterectomy (OR, 2.63; P = .06). In addition, concomitant hysterectomy was significantly associated with increased risk of mesh extrusion compared with previous hysterectomy (OR, 2.27; P =.03), Dr. Ehsani said at the meeting, which was jointly sponsored by the American College of Surgeons.

The researchers conducted a case-control study of women who underwent an abdominal sacral colpopexy (ASC) or vaginal mesh procedure (VMP) and developed mesh extrusion. Cases were matched with controls in a ratio of 1:3 by procedure data and type. Cases and controls were identified using diagnosis and procedure codes. Cases and control patients underwent the procedures between January 2006 and December 2009. The researchers collected information on age, race, type of procedure, estrogen status, hysterectomy status, type of vaginal incision, comorbidities, and smoking history.

They identified 84 case patients – 43 who underwent an ASC and 41 who underwent a VMP – and 314 controls. The mean age of the entire patient population was 62 years, with a median body mass index of 27.1 kg/m². The median time to the diagnosis of mesh extrusion was 16 weeks. Patients with ASCs were significantly younger than women in the other groups; patients in the ASC and control groups were significantly less likely to be smokers.

Mesh extrusion occurred most commonly in the anterior compartment (44%) in women who had a VMP, followed by the apical compartment (34%) and the posterior compartment (22%). Among women who had an ASC, extrusion occurred most commonly in the posterior compartment (63%), and occurred in the anterior compartment in 7% and in the apical compartment in 7%. Compartment status was unknown for 23% of women who had an ASC.

Concomitant hysterectomy is a significant risk factor for mesh extrusion in pelvic reconstructive surgery. "If a hysterectomy is indicated at the time of prolapse surgery, different approaches should be considered. When performing an abdominal sacral colpopexy, surgeons may want to consider a supracervical approach. This must be weighed against the risks of cervical preservation, including future cervical pathology and bleeding, as well as patient desires," said Dr. Ehsani of the department of obstetrics and gynecology at St. Luke’s Hospital in Bethlehem, Pa. "In the case of vaginal mesh procedure, surgeons may want to consider making separate vaginal incisions for mesh placement – that do not connect the vaginal cuff incision."

Dr. Ehsani reported that she is a consultant for American Medical Systems. Two of her coauthors are also consultants for American Medical Systems and Ethicon.

BALTIMORE – Concomitant hysterectomy increases the risk of mesh extrusion in pelvic reconstructive surgery by more than fivefold, according to the results of a retrospective case-control study of women undergoing abdominal sacral colpopexy or vaginal mesh procedures.

"This is a very timely and important research topic, especially given the recent [Food and Drug Administration] advisory," said Dr. Nazanin Ehsani, who presented the results at the annual meeting of the Society of Gynecologic Surgeons.

In 2008 and again in 2011, the FDA issued warnings about the use of transvaginal mesh. The 2011 warning was issued to inform health care professionals that serious complications associated with surgical mesh for transvaginal repair of pelvic organ prolapse (POP) are not rare. The agency also noted that it is not clear that transvaginal repair with mesh is more effective than traditional non-mesh repair in all patients with POP, and it may expose patients to greater risk.

On multivariate analysis, concomitant hysterectomy was associated with an increased risk of mesh extrusion compared with no hysterectomy (odds ratio, 5.97; P = .003). Previous hysterectomy showed a trend toward increased risk of mesh extrusion compared with no hysterectomy (OR, 2.63; P = .06). In addition, concomitant hysterectomy was significantly associated with increased risk of mesh extrusion compared with previous hysterectomy (OR, 2.27; P =.03), Dr. Ehsani said at the meeting, which was jointly sponsored by the American College of Surgeons.

The researchers conducted a case-control study of women who underwent an abdominal sacral colpopexy (ASC) or vaginal mesh procedure (VMP) and developed mesh extrusion. Cases were matched with controls in a ratio of 1:3 by procedure data and type. Cases and controls were identified using diagnosis and procedure codes. Cases and control patients underwent the procedures between January 2006 and December 2009. The researchers collected information on age, race, type of procedure, estrogen status, hysterectomy status, type of vaginal incision, comorbidities, and smoking history.

They identified 84 case patients – 43 who underwent an ASC and 41 who underwent a VMP – and 314 controls. The mean age of the entire patient population was 62 years, with a median body mass index of 27.1 kg/m². The median time to the diagnosis of mesh extrusion was 16 weeks. Patients with ASCs were significantly younger than women in the other groups; patients in the ASC and control groups were significantly less likely to be smokers.

Mesh extrusion occurred most commonly in the anterior compartment (44%) in women who had a VMP, followed by the apical compartment (34%) and the posterior compartment (22%). Among women who had an ASC, extrusion occurred most commonly in the posterior compartment (63%), and occurred in the anterior compartment in 7% and in the apical compartment in 7%. Compartment status was unknown for 23% of women who had an ASC.

Concomitant hysterectomy is a significant risk factor for mesh extrusion in pelvic reconstructive surgery. "If a hysterectomy is indicated at the time of prolapse surgery, different approaches should be considered. When performing an abdominal sacral colpopexy, surgeons may want to consider a supracervical approach. This must be weighed against the risks of cervical preservation, including future cervical pathology and bleeding, as well as patient desires," said Dr. Ehsani of the department of obstetrics and gynecology at St. Luke’s Hospital in Bethlehem, Pa. "In the case of vaginal mesh procedure, surgeons may want to consider making separate vaginal incisions for mesh placement – that do not connect the vaginal cuff incision."

Dr. Ehsani reported that she is a consultant for American Medical Systems. Two of her coauthors are also consultants for American Medical Systems and Ethicon.

BALTIMORE – Concomitant hysterectomy increases the risk of mesh extrusion in pelvic reconstructive surgery by more than fivefold, according to the results of a retrospective case-control study of women undergoing abdominal sacral colpopexy or vaginal mesh procedures.

"This is a very timely and important research topic, especially given the recent [Food and Drug Administration] advisory," said Dr. Nazanin Ehsani, who presented the results at the annual meeting of the Society of Gynecologic Surgeons.

In 2008 and again in 2011, the FDA issued warnings about the use of transvaginal mesh. The 2011 warning was issued to inform health care professionals that serious complications associated with surgical mesh for transvaginal repair of pelvic organ prolapse (POP) are not rare. The agency also noted that it is not clear that transvaginal repair with mesh is more effective than traditional non-mesh repair in all patients with POP, and it may expose patients to greater risk.

On multivariate analysis, concomitant hysterectomy was associated with an increased risk of mesh extrusion compared with no hysterectomy (odds ratio, 5.97; P = .003). Previous hysterectomy showed a trend toward increased risk of mesh extrusion compared with no hysterectomy (OR, 2.63; P = .06). In addition, concomitant hysterectomy was significantly associated with increased risk of mesh extrusion compared with previous hysterectomy (OR, 2.27; P =.03), Dr. Ehsani said at the meeting, which was jointly sponsored by the American College of Surgeons.

The researchers conducted a case-control study of women who underwent an abdominal sacral colpopexy (ASC) or vaginal mesh procedure (VMP) and developed mesh extrusion. Cases were matched with controls in a ratio of 1:3 by procedure data and type. Cases and controls were identified using diagnosis and procedure codes. Cases and control patients underwent the procedures between January 2006 and December 2009. The researchers collected information on age, race, type of procedure, estrogen status, hysterectomy status, type of vaginal incision, comorbidities, and smoking history.

They identified 84 case patients – 43 who underwent an ASC and 41 who underwent a VMP – and 314 controls. The mean age of the entire patient population was 62 years, with a median body mass index of 27.1 kg/m². The median time to the diagnosis of mesh extrusion was 16 weeks. Patients with ASCs were significantly younger than women in the other groups; patients in the ASC and control groups were significantly less likely to be smokers.

Mesh extrusion occurred most commonly in the anterior compartment (44%) in women who had a VMP, followed by the apical compartment (34%) and the posterior compartment (22%). Among women who had an ASC, extrusion occurred most commonly in the posterior compartment (63%), and occurred in the anterior compartment in 7% and in the apical compartment in 7%. Compartment status was unknown for 23% of women who had an ASC.

Concomitant hysterectomy is a significant risk factor for mesh extrusion in pelvic reconstructive surgery. "If a hysterectomy is indicated at the time of prolapse surgery, different approaches should be considered. When performing an abdominal sacral colpopexy, surgeons may want to consider a supracervical approach. This must be weighed against the risks of cervical preservation, including future cervical pathology and bleeding, as well as patient desires," said Dr. Ehsani of the department of obstetrics and gynecology at St. Luke’s Hospital in Bethlehem, Pa. "In the case of vaginal mesh procedure, surgeons may want to consider making separate vaginal incisions for mesh placement – that do not connect the vaginal cuff incision."

Dr. Ehsani reported that she is a consultant for American Medical Systems. Two of her coauthors are also consultants for American Medical Systems and Ethicon.