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Breast Reconstruction at Penn Plastic Surgery: Patient Safety is Paramount

At Penn Plastic Surgery, the options for breast reconstruction include free flap (autologous) tissue transplantation and mammoplasty, the surgical placement of breast implants.

At this time, Penn Medicine performs more non-implant reconstruction surgeries than any other center in the world -- and has a solid commitment to the success and safety of breast implant surgery, as well.

This is possible because Penn’s reconstructive breast surgeons are at the forefront of their field -- innovating surgical techniques and regularly contributing to the growing body of literature on the breast reconstruction.

Moreover, patients come to Penn Medicine for our surgeons’ world-renowned excellence in clinical practice, and their commitment to patient safety.

When it comes to breast reconstruction, says Joseph M. Serletti, MD, FACS, Chief of Penn Plastic Surgery, patient safety is paramount. Penn Plastic Surgery’s clinical team prioritizes patient safety during every step of breast reconstruction with implants.


Penn’s Patient Education Before Breast Implant Surgery

Breast implants are either saline-filled or silicone-gel filled, and come in a variety of configurations. Whatever their shape or composition, implants have been closely investigated and reviewed by the U.S. Food and Drug Administration (FDA) for many years.

Joseph M. Serletti, MD, FACS

Silicone gel implants, for example, have been reviewed by the FDA since 1990, and cleared for general use since the mid-90s.

“Even though they’re very safe, and even though they have such a long history of scrutiny, we take vigilance very seriously here,” Dr. Serletti explained. “If your patient needs breast reconstruction with implants, you can trust us with their ongoing health.”

Prior to surgery, patients meet with one of Penn Plastic Surgery’s Advanced Practice Providers to review the risks of surgery and sign a multi-page consent form. The consent form ensures that the patient fully understands the potential risks involved in surgery.

Patients are informed about the more common complications of breast implants, like infections and capsular contraction (a thick scarring of the capsule that leads to reduced cosmesis).

Penn Plastic Surgeons also review rare events like Breast Implant Associated-Anaplastic Large Cell Lymphoma (BIA-ALCL) and potential auto-immune reactions.


Reducing the Risk of Infection

Penn’s breast surgeons reduce the risk of infection and capsular contraction with a meticulous commitment to keeping the surgery site disinfected during the procedure.

“We are extremely careful in the OR, in terms of surgical techniques and handling of the implant,” said Dr. Serletti. “We flush the implant as well as the pocket with several sources of antibiotic irrigation, and we make sure that the field is absolutely dry... meaning there’s no active bleeding,” he continued.

Dr. Serletti noted that infections are a particularly serious worry for patients. If they can’t be treated with antibiotics, the entire implant must be removed.


Breast Implant Associated-Anaplastic Large Cell Lymphoma (BIA-ALCL)

The FDA recently identified textured breast implants from manufacturer Allergen BIOCELL as a risk for anaplastic large cell lymphoma (ALCL), a rare form of lymphoma.

Breast implant-associated ALCL (or BIA-ALCL) usually occurs several years after a breast implant has been placed. It typically presents as an enlargement of the breast along with the collection of fluid around the implant.

Although BIA-ALCL is rare,  women who received the Allergan BIOCELL implants are at six times increased risk for BIA-ALCL.

“The scarring around a textured implant is itself textured,” Dr. Serletti said. “And there’s something about the textured component of the capsule that seems to develop the BIA-ALCL”.

He added that some physicians have theorized the condition is due to a low-grade gram-negative infection that impacts the local lymphocyte population and causes a malignancy.

“The overall incidence of BIA-ALCL is somewhere in the range of one in ten thousand to thirty-thousand cases,” Dr. Serletti continued, noting that there have only been about six hundred cases worldwide, and that about 11 million women currently have breast implants.

FDA’s Recent Request that Allergan Voluntary Recall Implants due to BIA-ALCL Link

In a few cases, BIA-ALCL has developed into an invasive lymphoma, requiring further treatment. Thus, on July 24th, the FDA issued a safety communication requesting that Allergan recall its BIOCELL textured breast implants and tissue expanders. Allergan agreed and is removing these products from the global market.


BIA-ALCL Symptoms and Treatment

BIA-ALCL is treated by removing the implant and capsule.

If a patient presents with textured implants who complain about the new onset of pain, swelling, or asymmetry between the breasts, refer them to their plastic surgeon for an evaluation as soon as possible.

Any fluid accumulation around the breast capsule should be drained and tested for lymphoma.

Women with textured breast implants who do not experience symptoms do not need to have them removed.

While Penn Medicine has not seen any cases of BIA-ALCL, academic medicine has begun to study the condition in earnest in the past few years. Its link to textured implants has been narrowed down to the layer of scar tissue that naturally forms around any medical implants in the body.

Another rare, though unproven, complication of breast implants is an auto-immune reaction after surgery.

“We tell patients that even though no one’s been able to prove it, there is still a rare risk of auto-immune-type symptoms after the placement of silicone style breast implants,” Dr. Serletti said.

He noted that patients with these symptoms often improve after their implants are removed.

“I believe there are rare patients who are sensitive to breast implants, even though no scientific party has been able to prove a cause-and-effect relationship,” he continued. “Disclosing these facts is part of our informed consent process.”


Consult With Penn Plastic Surgeons About Your Patient

To consult with a Penn plastic surgeon about your patient, call Penn’s provider-only line at 877-937-7366.

To refer a patient for a breast reconstruction consultation or BIA-ALCL evaluation, call 877-937-7366 or use our online patient referral form.

Learn more about Dr. Serletti and the team of board-certified plastic surgeons who comprise Penn’s breast reconstruction team


Additional Breast Implant and Reconstruction Resources from Penn Medicine

Penn Medicine, Philadelphia, PA 800-789-7366 © , The Trustees of the University of Pennsylvania

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