Secondary Female Infertility: The Far-Reaching Effects of Adhesions

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Secondary Female Infertility: The Far-Reaching Effects of Adhesions

Gynecological and abdominal surgery can cause trauma that leads to post-surgical adhesions.1 Adhesions have been associated with a range of complications that affect a woman’s reproductive health and fertility.1–3 Here, Amanda Schamper, BSN, RN, Principal Medical Liaison at Baxter Healthcare Corporation, discusses the far-reaching effects of adhesions and the possible role of adhesion prevention in protecting a woman’s fertility.

The complications arising from post-surgical adhesions can range from mild to severe in nature.4 In some cases, their effects can lead to a lifelong risk of complications.5 Indeed, for some women undergoing abdominal or pelvic surgery, the consequences of post-surgical adhesions can have long term effects on their reproductive health and fertility.1–5

Several findings suggest a link between post-surgical adhesions and female fertility. Up to 90% of women undergoing major gynecologic surgery develop adhesions,1 and adhesions are considered a leading cause of secondary female infertility.1,2,5 This complication has been supported by evidence suggesting that full-term pregnancy rates correlate with adhesion scores.5-7 It is hypothesized that fertility might be affected because adhesions physically distort adnexal anatomy and thereby interfere with gamete and embryo transport.5

60-90%

of patients undergoing major gynecological surgery develop adhesions1

20–40%

of cases of infertility in women can be accounted for by adhesions1,3

Post-surgical adhesions not only make it more difficult to conceive, they are also associated with ectopic pregnancies and obstetric complications in those who manage to conceive.2,8

These obstetric complications can include miscarriage, premature rupture of membranes, premature delivery and placenta accreta.2

While some evidence suggests that surgical adhesiolysis can increase successful pregnancy rates compared with untreated women,5,6,9 the procedure comes with its own risks. For example, adhesiolysis can cause further tissue disruption and adhesion reformation is seen in around 85% of patients.9 Given these potential risks, for patients looking to preserve their fertility, adhesion prevention should be considered during surgery and its follow-up. Indeed, some international guidelines suggest such measures should be considered in high-risk patients, including any patient requiring surgery of the ovaries or uterus, patients who will require a secondary procedure, and patients undergoing laparoscopic gynecologic surgeries.10,11

There are several approaches to adhesion prevention. First and foremost, meticulous surgical technique is recognized as key. This can be supported by adjuncts such as anticoagulants, fibrinolytics, anti-inflammatory and anti-fibrotic agents. However, despite good surgical technique, the risk of adhesion formation cannot be completely eliminated due to the routine tissue trauma that occurs with any surgery which can be a factor in the development of adhesions.1 Adhesion barriers are another option to support surgical technique and have been shown to reduce post-surgical adhesions in patients undergoing gynecological laparoscopic adhesiolysis.3 While the impact of adhesion barriers on long term fertility remains to be determined, it can be hypothesized that reducing their incidence can support improved patient outcomes.

 

The association between adhesions and secondary female infertility show they can have long-reaching effects in women who wish to conceive.1–5

Unfortunately, it can be easy to overlook such complications because of the length of time between surgery and when adhesions first appear.1 Also, patients tend to be treated by someone other than the surgeon who conducted the first operation.1 ,7 While adhesiolysis may improve fertility, there is a risk of adhesion reformation.9 Therefore, it is worth considering adhesion prevention methods, such as ADEPT Adhesion Reduction Solution and SEPRAFILM Adhesion Barrier, that have been clinically proven to reduce the risk of adhesion formation in gynecologic surgical procedures.12,13

Indications and Important Safety Information

SEPRAFILM Indications for Use

SEPRAFILM Adhesion Barrier is indicated for use in patients undergoing abdominal or pelvic laparotomy as an adjunct intended to reduce the incidence, extent and severity of postoperative adhesions between the abdominal wall and the under-lying viscera such as omentum, small bowel, bladder, and stomach, and between the uterus and surrounding structures such as tubes and ovaries, large bowel, and bladder.

SEPRAFILM Important Risk Information

SEPRAFILM  Adhesion Barrier is contraindicated in patients with a history of hypersensitivity to Seprafilm and/or to any component of SEPRAFILM. SEPRAFILM Adhesion Barrier is contraindicated for use wrapped directly around a fresh anastomotic suture or staple line; as such use increases the risk of anastomotic leak and related events (fistula, abscess, leak, sepsis, peritonitis). SEPRAFILM Adhesion Barrier must be used according to the instructions for use. SEPRAFILM Adhesion Barrier is for single use only, supplied sterile and must not be re-sterilized. Every opened and unused SEPRAFILM pouch must be discarded. Do not use product if pouch is damaged or opened. The number of sheets used should be just adequate to cover the under surface of the abdominal wall or uterine incision in a single layer.

In patients who have ovarian, primary peritoneal or fallopian tube malignancies, SEPRAFILM use has been reported to have an increased risk of intra-abdominal fluid collection and/or abscess, particularly when extensive debulking surgery was required.

The safety and effectiveness of SEPRAFILM Adhesion Barrier has not been evaluated in clinical studies for the following: Patients with frank infections in the abdominopelvic cavity; patients with abdominopelvic malignancy; device placement in locations other than directly beneath an abdominal wall incision following laparotomy, or directly on the uterus following open myomectomy (not laparoscopic); patients with ongoing local and/or systemic inflammatory cell responses; device use in the presence of other implants, e.g. surgical mesh; patients requiring re-operation within four weeks of SEPRAFILM placement – during anticipated time of peak adhesion formation. Foreign body reactions have occurred with SEPRAFILM Adhesion Barrier.

The safety and effectiveness of SEPRAFILM Adhesion Barrier in combination with other adhesion prevention products and/or in other surgical procedures not within the abdominopelvic cavity have not been established in clinical studies.

The safe and effective use of SEPRAFILM Adhesion Barrier in pregnancy and Cesarean section has not been evaluated. No clinical studies have been conducted in pregnant women or women who have become pregnant within the first month after exposure to SEPRAFILM Adhesion Barrier. Therefore, this product is not recommended for use during pregnancy and avoidance of conception should be considered during the first complete menstrual cycle after use of SEPRAFILM Adhesion Barrier.

Long term clinical outcomes such as chronic pain and infertility have not been determined in clinical studies.

Rx Only.  For safe and proper use of this device refer to the complete Instructions for Use.

SEPRAFILM Full Instructions For Use

ADEPT® Adhesion Reduction Solution [4% Icodextrin] Indications

ADEPT® Adhesion Reduction Solution is indicated for use intraperitoneally as an adjunct to good surgical technique for the reduction of post-surgical adhesions in patients undergoing gynecological laparoscopic adhesiolysis.

ADEPT® Adhesion Reduction Solution [4% Icodextrin] Important Risk Information

ADEPT®  Solution is for direct intraperitoneal administration only. NOT for intravenous (IV) administration.

ADEPT® is contraindicated in patients with known or suspected allergy to cornstarch based polymers e.g. icodextrin, or with maltose or isomaltose intolerance, or with glycogen storage disease.

ADEPT® is contraindicated in laparotomy, in cases involving bowel resection or repair, or appendectomy and in surgical cases with frank abdomino-pelvic infection.

There have been rare reports of sterile peritonitis following the use of icodextrin.

Leakage of ADEPT® from port sites may lead to wound healing complications; meticulous fascial closure may reduce leakage through laparoscopic port sites post-operatively.

There have been rare reports of hypersensitivity reactions, pulmonary edema, pulmonary effusion and arrhythmia.

Anaphylaxis has been reported in a few patients.

Maltose metabolites of icodextrin may interfere with blood glucose measurement in diabetic patients who use rapid blood glucose systems that are not glucose specific.

In the pivotal study, the most frequently occurring treatment related adverse events between surgeries were post procedural leaking from port sites, labial, vulvar or vaginal swelling and abdominal distention.

Rx Only: For safe and proper use of this device, please refer to full Instructions For Use.

ADEPT Full Instructions For Use